Severe Acute Respiratory Syndrome Coronavirus 2Phase 1NCT04461353
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
A Phase 1 study testing Aerolized Hydroxychloroquine Sulfate in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by Pulmoquine Therapeutics, Inc at 1 site in United States.
Trial summary
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: To assess the safety and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Aerolized Hydroxychloroquine Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 17 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent.
- Males or females aged ≥18 years old.
- Good general health as determined by no acute illness and no clinically significant abnormal findings on medical history, vital signs, laboratory tests, or physical examination at screening that, in the opinion of the PI, would interfere with study drug administration, jeopardize the safety of the study participant, or impact the validity of the study results; participants with stable chronic illness are allowed at the discretion of the PI.
- An interpretable 12-lead ECG with a corrected QT (QTc) interval ≤450 ms, according to Bazett's formula, without evidence of clinically significant abnormal findings.
- Normal FEV1/FVC ratio, defined as any value above 0.7 or above the lower 5th percentile of normal AND FEV1 >80% of predicted or above the lower 5th percentile of normal.
- Pulse oximetry 02 saturation ≥95% in room air.
Show all 15Show fewer
- Negative test result for COVID-19 within 7 days of Day 1 AND concurrent with local hospital policy:
- A nasopharyngeal swab tested with the ID NOW COVID-19 assay (Abbot). OR
- A negative RNA-based test result of an oropharyngeal or nasopharyngeal swab or saliva sample performed according to CLIA/CLEP.
- Females of child-bearing potential must be non-pregnant, non-lactating, have a negative urine pregnancy test at screening, and agree to use an acceptable form of birth control for 200 days after the last administration of the study drug. Females are considered of non-childbearing potential if they are postmenopausal (last menstrual period at least 1 year before screening) or have been surgically sterilized (documented hysterectomy, tubal ligation, or bilateral oophorectomy) for at least 6 months at screening.
- Willing to comply with protocol-defined procedures and complete all study visits.
- Willing to use the Inhalation System and exhale through the nose.
- Adequate venous access in the left or right arm to allow collection of required blood samples.
- Participant understands and communicates in English.
- Serum Potassium level ≥3.5 mEq/L, Serum Magnesium level ≥1.5 mg/dL, and Serum Calcium ≥8.5 mg/dL.
Who cannot join
- Any self-reported symptoms of influenza-like or COVID-19-like illness in the 14 days preceding the study visit: Fever >101.4 °F, sore throat, nasal congestion, post-nasal discharge, shortness of breath, gastrointestinal distress, wheezing, cough, headache, or fatigue.
- Any history of diagnosed chronic lung disease, including but not limited to asthma or chronic obstructive lung disease.
- Symptoms of seasonal allergies or use of any drugs for seasonal allergies or any inhaled (oral/nasal) drugs in the 2 weeks prior to Day 1. Mild seasonal allergy symptoms that have not altered sleep or activity patterns nor required use of over-the-counter (OTC) or prescription medications are allowed.
- Any close contact exposure in the past 28 days to a person who was diagnosed as having COVID-19, with or without laboratory confirmation, during that close contact exposure or in the ensuing 14 days OR a similar encounter with a person who was determined to have suspected COVID-19, defined by that person being ordered to enter isolation for that indication by a medical authority. Close contact is defined as being within approximately 6 feet of a COVID-19 case for a prolonged (>10 minutes) period of time and can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 patient OR having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on), if such contact occurred while not wearing the recommended personal protective equipment for that type of contact [e.g., gowns, gloves, N95 respirator (or equivalent), eye protection].
- Any participant with a history of SARS-CoV-2 infection that was confirmed by testing or diagnosed without testing within 4 weeks preceding Day 1. If infection occurred more than 4 weeks prior, candidates may be enrolled if they meet the rest of the eligibility criteria.
- Any participant with a history severe respiratory illness that required hospitalization in the 60 days preceding Day 1 OR any participant with a history severe respiratory illness that required hospitalization in the preceding 120 days without full recovery.
Show all 18Show fewer
- Participation in another clinical study that involved treatment with an investigational product or device within 30 days of screening or during the study.
- Participants with a known history of human immunodeficiency virus (HIV) infection.
- Known, active hepatitis A, B, or C infection.
- History of bronchospasm in response to use of an inhalation device.
- Use of any prescription medication (except oral contraceptives) during the 30 days prior to study dosing that may affect drug absorption, metabolism and excretion, prolong the QTc interval, affect drug efficacy, or increase the risk of adverse reactions, unless approved by the Principal Investigator.
- Use of any OTC product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by the Principal Investigator.
- Unwilling or unable to provide written informed consent.
- Any known hypersensitivity to quinolines (e.g., hydroxychloroquine, chloroquine, primaquine, quinine) or known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or any contraindication to oral hydroxychloroquine.
- Known retinopathy, fundus disease, or macular disease.
- Diagnosis of long QT Syndrome.
- Smoking of tobacco or non-tobacco substances, or vaping, within the last 6 months.
- Severe obesity (body mass index [BMI] ≥35 kg/m2).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: A Phase 1 Randomized Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows:
- To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered.
- To determine the recommended Phase 2a dose (RP2D).
Secondary objectives:
- To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
Read the detailed description
Study Design:
This is a randomized, double-blind placebo-controlled Phase 1 single-dose dose-escalation study to assess the safety, tolerability and PK of oral inhalation of AHCQ in healthy participants.
Escalating single doses of AHCQ will be studied in healthy participants. The study drug will be administered by inhalation through the mouth, and participants will be encouraged to exhale through the nose. The study drug, AHCQ, will be administered starting at an initial dose of 20 mg (Cohort A1, 1 mL of 20 mg/mL AHCQ solution) with a proposed subsequent doses of 50 mg (Cohort A2, 1 mL of 50 mg/mL AHCQ).
Number of Participants (Planned):
Two dose levels are planned to be evaluated. Each cohort will comprise 8 participants (6 active, 2 placebo). Therefore, 16 participants will initially be planned to be enrolled in the study. Additional participants may be enrolled if one or more enrolled participants do not complete the study.
- Being tested
- Aerolized Hydroxychloroquine Sulfate, Placebo
- Keywords
- coronavirus, COVID-19, Hydroxychloroquine Sulfate, Hydroxychloroquine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerolized Hydroxychloroquine SulfateDrug
Also called AHCQ
sterile AHCQ 100 mg/mL for inhalation, is a clear solution packaged in clear glass vials and stored at room temperature.
PlaceboOther
The placebo product and diluent solution is sodium chloride inhalation solution, United States Pharmacopeia (USP) 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine Sulfate | Active comparator | The study drug AHCQ will be administered by inhalation through the mouth. The starting dose will be 20 mg (Cohort A1) with a proposed subsequent dose of 50 mg (Cohort A2). At each dose level 8 participants (including at least 3 female participants and 3 participants older than 50 years old) will be enrolled. Six participants will receive the active study drug and 2 participants will receive placebo. Receives: Drug: Aerolized Hydroxychloroquine Sulfate |
| Placebo | Placebo comparator | Placebo will be administered by inhalation through the mouth. It will be administered in both Cohort A1 and Cohort A2. Six participants will receive the active study drug and 2 participants will receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0
TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)
Measured: after treatment (Day 1) through to Day 30
Change from baseline in clinical laboratory test results for CBC with differential
Blood sample collected for CBC with differential will be assessed from baseline (at screening)
Measured: Screening and Day 8
Incidence of abnormal laboratory test results for CBC with differential at Screening
Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests
Measured: Screening
Incidence of abnormal laboratory test results for CBC with differential - Day 8
Day 8 blood sample collected for CBC with differential
Measured: Day 8
Changes from baseline for blood glucose
Blood sample collected for blood glucose and measured with a glucometer
Measured: Screening and Day 1
Incidence of abnormal laboratory test results for chemistry -Screening
Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measured: Screening
Incidence of abnormal laboratory tests results for chemistry - Day 8
Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measured: Day 8
Incidence of abnormal laboratory tests results for urinalysis - Screening
Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measured: Screening
Incidence of abnormal laboratory tests results for urinalysis- Day 8
Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measured: Day 8
Changes in vital signs from baseline (pre-dose) - respiratory rate
The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)
Measured: Screening, Day 1, Day 2 and Day 8
Changes in vital signs from baseline (pre-dose)- temperature
Oral temperature
Measured: Screening, Day 1, Day 2 and Day 8
Changes in vital signs from baseline (pre-dose) - seated blood pressure
Systolic and diastolic blood pressure
Measured: Screening, Day 1, Day 2 and Day 8
Changes in vital signs from baseline (pre-dose) - pulse
Heart rate measure by radial pulse rate (beats/min)
Measured: Screening, Day 1, Day 2 and Day 8
Changes in vital signs from baseline (pre-dose) - O2 saturation
O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter <92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)
Measured: Screening, Day 1, Day 2 and Day 8
Incidence of abnormal and physical examinations findings during Screening- general appearance
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - general appearance
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2- general appearance
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- general appearance
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening- neurological
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1- neurological
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2- neurological
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- neurological
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1 (pre-dose, within 3 hours of dose)
Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening - lungs
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - lungs
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2 - lungs
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8 - lungs
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening- abdomen
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - abdomen
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2- abdomen
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- abdomen
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during screening- endocrine
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - endocrine
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2- endocrine
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- endocrine
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening- extremities
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1- extremities
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2- extremities
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- extremities
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during Screening- lymphatic
Physical exam by clinician. A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1- lymphatic
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2 - lymphatic
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8- lymphatic
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Incidence of abnormal and physical examinations findings during screening - skin
A directed physical examination will be conducted
Measured: Screening
Incidence of abnormal and physical examinations findings on Day 1 - skin
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 1
Incidence of abnormal and physical examinations findings on Day 2 - skin
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 2
Incidence of abnormal and physical examinations findings on Day 8 - skin
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measured: Day 8
Changes from baseline for pulmonary function tests (PFTs) - FEV1
Pulmonary function testing and recording of FEV1, both actual and percent predicted
Measured: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Changes from baseline for pulmonary function tests (PFTs) - FVC
Pulmonary function testing and recording of FVC, , both actual and percent predicted
Measured: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC
Pulmonary function testing and recording of FEV1/FVC
Measured: creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Changes from baseline for ECG readings - QT interval
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QT Interval (msec) will be the assessment parameter.
Measured: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
Changes from baseline for ECG readings - QTcB Interval
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QTcB interval (msec) will be the assessment parameter.
Measured: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
Changes from baseline for ECG readings - QRS duration
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QRS duration (msec) will be the assessment parameter.
Measured: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
Changes from baseline for ECG readings - PR interval
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG PR interval (msec) will be the assessment parameter.
Measured: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
Changes from baseline for ECG readings - heart rate
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG heart rate (beats/min) will be the assessment parameter.
Measured: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
Incidence of abnormal ECG - Screening
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QT Interval will be the assessment parameter.
Measured: Screening
Incidence of abnormal ECG- Day 1
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QT Interval will be the assessment parameter.
Measured: Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hours
Incidence of abnormal ECG - Day 2
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QT Interval will be the assessment parameter.
Measured: Days 2
Incidence of abnormal ECG - Day 8
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing.
ECG QT Interval will be the assessment parameter.
Measured: Days 8.
Secondary outcomes (1)
HCQ concentration in whole blood versus time profiles
Blood samples for PK analysis will be collected via indwelling catheter or via direct venipuncture.
Measured: Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start25 Jun 2020
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind placebo-controlled Phase 1 single-dose dose-escalation study to assess the safety, tolerability and PK of oral inhalation of AHCQ in healthy participants. A sentinel dose strategy will be employed and the decision to escalate to the next dose level, or deescalate or stop the study, will be based on review and analysis of all available blinded safety and tolerability data by the Safety Review Committee (SRC), which will make a recommendation to the Sponsor and the Sponsor will inform the PI of the recommendation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmoquine Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Ohad S Bentur, MD, MHA, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461353
- Sponsor's protocol ID
- PUL-01
- Status last verified
- Aug 2020
- First submitted
- 23 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04461353
- Acronym / sponsor ID
- PUL-01
- Keywords
- coronavirus, COVID-19, Hydroxychloroquine Sulfate, Hydroxychloroquine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pulmoquine Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Rockefeller University
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows:
- To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered.
- To determine the recommended Phase 2a dose (RP2D).
Secondary objectives:
- To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
Detailed description
Study Design:
This is a randomized, double-blind placebo-controlled Phase 1 single-dose dose-escalation study to assess the safety, tolerability and PK of oral inhalation of AHCQ in healthy participants.
Escalating single doses of AHCQ will be studied in healthy participants. The study drug will be administered by inhalation through the mouth, and participants will be encouraged to exhale through the nose. The study drug, AHCQ, will be administered starting at an initial dose of 20 mg (Cohort A1, 1 mL of 20 mg/mL AHCQ solution) with a proposed subsequent doses of 50 mg (Cohort A2, 1 mL of 50 mg/mL AHCQ).
Number of Participants (Planned):
Two dose levels are planned to be evaluated. Each cohort will comprise 8 participants (6 active, 2 placebo). Therefore, 16 participants will initially be planned to be enrolled in the study. Additional participants may be enrolled if one or more enrolled participants do not complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind placebo-controlled Phase 1 single-dose dose-escalation study to assess the safety, tolerability and PK of oral inhalation of AHCQ in healthy participants. A sentinel dose strategy will be employed and the decision to escalate to the next dose level, or deescalate or stop the study, will be based on review and analysis of all available blinded safety and tolerability data by the Safety Review Committee (SRC), which will make a recommendation to the Sponsor and the Sponsor will inform the PI of the recommendation.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine Sulfate | Active comparator | Drug: Aerolized Hydroxychloroquine SulfateThe study drug AHCQ will be administered by inhalation through the mouth. The starting dose will be 20 mg (Cohort A1) with a proposed subsequent dose of 50 mg (Cohort A2). At each dose level 8 participants (including at least 3 female participants and 3 participants older than 50 years old) will be enrolled. Six participants will receive the active study drug and 2 participants will receive placebo. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be administered by inhalation through the mouth. It will be administered in both Cohort A1 and Cohort A2. Six participants will receive the active study drug and 2 participants will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to give written informed consent.
- Males or females aged ≥18 years old.
- Good general health as determined by no acute illness and no clinically significant abnormal findings on medical history, vital signs, laboratory tests, or physical examination at screening that, in the opinion of the PI, would interfere with study drug administration, jeopardize the safety of the study participant, or impact the validity of the study results; participants with stable chronic illness are allowed at the discretion of the PI.
- An interpretable 12-lead ECG with a corrected QT (QTc) interval ≤450 ms, according to Bazett's formula, without evidence of clinically significant abnormal findings.
- Normal FEV1/FVC ratio, defined as any value above 0.7 or above the lower 5th percentile of normal AND FEV1 >80% of predicted or above the lower 5th percentile of normal.
Key exclusion criteria (18 listed)
- Any self-reported symptoms of influenza-like or COVID-19-like illness in the 14 days preceding the study visit: Fever >101.4 °F, sore throat, nasal congestion, post-nasal discharge, shortness of breath, gastrointestinal distress, wheezing, cough, headache, or fatigue.
- Any history of diagnosed chronic lung disease, including but not limited to asthma or chronic obstructive lung disease.
- Symptoms of seasonal allergies or use of any drugs for seasonal allergies or any inhaled (oral/nasal) drugs in the 2 weeks prior to Day 1. Mild seasonal allergy symptoms that have not altered sleep or activity patterns nor required use of over-the-counter (OTC) or prescription medications are allowed.
- Any close contact exposure in the past 28 days to a person who was diagnosed as having COVID-19, with or without laboratory confirmation, during that close contact exposure or in the ensuing 14 days OR a similar encounter with a person who was determined to have suspected COVID-19, defined by that person being ordered to enter isolation for that indication by a medical authority. Close contact is defined as being within approximately 6 feet of a COVID-19 case for a prolonged (>10 minutes) period of time and can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 patient OR having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on), if such contact occurred while not wearing the recommended personal protective equipment for that type of contact [e.g., gowns, gloves, N95 respirator (or equivalent), eye protection].
- Any participant with a history of SARS-CoV-2 infection that was confirmed by testing or diagnosed without testing within 4 weeks preceding Day 1. If infection occurred more than 4 weeks prior, candidates may be enrolled if they meet the rest of the eligibility criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerolized Hydroxychloroquine SulfateAlso: AHCQsterile AHCQ 100 mg/mL for inhalation, is a clear solution packaged in clear glass vials and stored at room temperature. | Drug | Hydroxychloroquine Sulfate |
| PlaceboThe placebo product and diluent solution is sodium chloride inhalation solution, United States Pharmacopeia (USP) 0.9%. | Other | Placebo |
Primary outcome
Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0
Time frame: after treatment (Day 1) through to Day 30
TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)
Change from baseline in clinical laboratory test results for CBC with differential
Time frame: Screening and Day 8
Blood sample collected for CBC with differential will be assessed from baseline (at screening)
Incidence of abnormal laboratory test results for CBC with differential at Screening
Time frame: Screening
Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests
Incidence of abnormal laboratory test results for CBC with differential - Day 8
Time frame: Day 8
Day 8 blood sample collected for CBC with differential
Changes from baseline for blood glucose
Time frame: Screening and Day 1
Blood sample collected for blood glucose and measured with a glucometer
Incidence of abnormal laboratory test results for chemistry -Screening
Time frame: Screening
Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Incidence of abnormal laboratory tests results for chemistry - Day 8
Time frame: Day 8
Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Incidence of abnormal laboratory tests results for urinalysis - Screening
Time frame: Screening
Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Incidence of abnormal laboratory tests results for urinalysis- Day 8
Time frame: Day 8
Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Changes in vital signs from baseline (pre-dose) - respiratory rate
Time frame: Screening, Day 1, Day 2 and Day 8
The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)
Changes in vital signs from baseline (pre-dose)- temperature
Time frame: Screening, Day 1, Day 2 and Day 8
Oral temperature
Changes in vital signs from baseline (pre-dose) - seated blood pressure
Time frame: Screening, Day 1, Day 2 and Day 8
Systolic and diastolic blood pressure
Changes in vital signs from baseline (pre-dose) - pulse
Time frame: Screening, Day 1, Day 2 and Day 8
Heart rate measure by radial pulse rate (beats/min)
Changes in vital signs from baseline (pre-dose) - O2 saturation
Time frame: Screening, Day 1, Day 2 and Day 8
O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter <92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)
Incidence of abnormal and physical examinations findings during Screening- general appearance
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - general appearance
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2- general appearance
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- general appearance
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening- neurological
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1- neurological
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2- neurological
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- neurological
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular
Time frame: Day 1 (pre-dose, within 3 hours of dose)
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening - lungs
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - lungs
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2 - lungs
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8 - lungs
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening- abdomen
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - abdomen
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2- abdomen
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- abdomen
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during screening- endocrine
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - endocrine
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2- endocrine
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- endocrine
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening- extremities
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1- extremities
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2- extremities
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- extremities
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during Screening- lymphatic
Time frame: Screening
Physical exam by clinician. A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1- lymphatic
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2 - lymphatic
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8- lymphatic
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings during screening - skin
Time frame: Screening
A directed physical examination will be conducted
Incidence of abnormal and physical examinations findings on Day 1 - skin
Time frame: Day 1
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 2 - skin
Time frame: Day 2
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Incidence of abnormal and physical examinations findings on Day 8 - skin
Time frame: Day 8
Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Changes from baseline for pulmonary function tests (PFTs) - FEV1
Time frame: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Pulmonary function testing and recording of FEV1, both actual and percent predicted
Changes from baseline for pulmonary function tests (PFTs) - FVC
Time frame: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Pulmonary function testing and recording of FVC, , both actual and percent predicted
Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC
Time frame: creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.
Pulmonary function testing and recording of FEV1/FVC
Changes from baseline for ECG readings - QT interval
Time frame: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval (msec) will be the assessment parameter.
Changes from baseline for ECG readings - QTcB Interval
Time frame: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QTcB interval (msec) will be the assessment parameter.
Changes from baseline for ECG readings - QRS duration
Time frame: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QRS duration (msec) will be the assessment parameter.
Changes from baseline for ECG readings - PR interval
Time frame: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG PR interval (msec) will be the assessment parameter.
Changes from baseline for ECG readings - heart rate
Time frame: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG heart rate (beats/min) will be the assessment parameter.
Incidence of abnormal ECG - Screening
Time frame: Screening
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Incidence of abnormal ECG- Day 1
Time frame: Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hours
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Incidence of abnormal ECG - Day 2
Time frame: Days 2
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Incidence of abnormal ECG - Day 8
Time frame: Days 8.
The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
1 secondary outcome
HCQ concentration in whole blood versus time profiles
Time frame: Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
Related trials for Severe Acute Respiratory Syndrome Coronavirus 2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ohad S Bentur, MD, MHA principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aerolized Hydroxychloroquine Sulfate in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by Pulmoquine Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0 (time frame: after treatment (Day 1) through to Day 30). The study lists 62 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.