2019 Novel CoronavirusPhase 2NCT05113810
The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19
A Phase 2 study testing HCQ01 in people with 2019 Novel Coronavirus, run by Ministry of Health Jordan at 1 site in Jordan.
Trial summary
This is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 2019 Novel Coronavirus
- What is being tested?
- HCQ01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteJordan
- Study dates
- 20 Mar 2022to 20 Jul 2022
- Phase
- Phase 2
- 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
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
- Patients with a history of retinopathy, sickle cell disease or trait, psoriasis, porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder, known active tuberculosis or history of incompletely treated tuberculosis, patients on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants.
- Patients admitted in ICU.
- Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone , cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and during the duration of the study.
- History of Glucose-6-phosphate dehydrogenase deficiency.
- Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.
Who cannot join
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
- Patients with a history of retinopathy, sickle cell disease or trait, psoriasis, porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder, known active tuberculosis or history of incompletely treated tuberculosis, patients on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants.
- Patients admitted in ICU.
- Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone , cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and during the duration of the study.
- History of Glucose-6-phosphate dehydrogenase deficiency.
- Pre-treatment corrected QT interval (QTc) ≥450 milliseconds.
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- Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30 mL/min/1.73 m2 or hemodialysis).
- Liver Child-Pugh grade C.
- Patients with Hypokalemia (<3.5mmol/L), Hypocalcemia (<2.2mmol/L), Hypomagnesemia (<0.66mmol/L). Will be included after correction.
- Need for mechanical ventilation.
- History of hypersensitivity to hydroxychloroquine.
- History of Chronic Hepatitis B or hepatitis C infections.
- History of Human Immunodeficiency Virus (HIV) infection.
- Concurrent serious illness including, but not limited to, any of the following:
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina).
- New York Heart Association class II-IV congestive heart failure.
- Serious cardiac arrhythmia requiring medication. -Peripheral vascular disease ≥ grade 2 within the past year. -
- Psychiatric illness/social situation that would limit compliance with study requirements. -COPD, Lung cancer, and moderate to severe asthma.
- Any other significant finding based on the judgment of the PI would increase the risk of having an adverse outcome from participating in this study.
- Any other concomitant treatment based on the judgment of the PI would increase the risk of having an adverse outcome from participating in this study.
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 80 days of signing the informed consent/assent for this current trial.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Prince Hamza Hospital/ Amman Field Hospital
Amman, 00962
Khaldoun Khader, MD
Mohammed Shakeeb, MSc, 0781633832, mshakeeb95@gmail.com
About this study
Official title: A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01for the Treatment of Patients With COVID-19
This is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized COVID-19 patients. The Jordanian Ministry of Health (MOH) is the study sponsor, and the study will be conducted at MOH COVID-19 hospitals.
Approximately 110 patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, will be enrolled and randomized 1:1 to the treatment and control arms where they will receive ten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the control arm where treatment will follow the MOH SOC.
- Conditions
- 2019 Novel Coronavirus
- Being tested
- HCQ01, standard of care (SOC) for COVID-19
- Keywords
- COVID-19, Inhaled/nebulized Hydroxychloroquine
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQ01Drug
HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization
standard of care (SOC) for COVID-19Other
Standard of care (SOC) for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| First Arm (Hydroxychloroquine sulfate, 5 days) | Experimental | Participants will receive continued standard of care therapy (SOC) for COVID-19 together with 2 ml HCQ01 (12.5 mg/ml) twice a day for 5 consecutive days. Receives: Drug: HCQ01 |
| Second Arm (Continued Standard of Care (SOC) Therapy) | Active comparator | Participants will receive continued standard of care therapy for COVID-19 Receives: Other: standard of care (SOC) for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO Ordinal Scale for for Clinical Improvement
Change in condition measured using the Ordinal Scale for Clinical Improvement. Patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead
Measured: [ Day -1 (screening) to Days 3,6, and 14 ]
Secondary outcomes (10)
Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI
Measured: Day 28
All-cause mortality
Measured: Day 28
HCQ concentration in plasma versus time profiles
Measured: Day 1 pre-dose (within 1-hour prior dosing) and +2, +5, +10, +15, +20, +25, and +30 minutes after dose, and also +1, +2, +3, +4 and +6 hours post-dose completion
Change from Baseline Oxygenation as determined by the SpO2/FiO2 ratio
Measured: Days 3 & 6
Rate of Transfer to the Intensive Care Unit
Measured: Up to day 28
Time to Hospital Discharge or NEWS2 (National Early Warning Score 2) of ≤ 2
Measured: Up to day 28
Treatment-related adverse events of HCQ
Measured: Up to day 28
Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia [Time Frame
Cardiologist Diagnostic Documentation
Measured: Up to day 6
Cardiac Arrhythmia - Ventricular Tachycardia
Cardiologist Diagnostic Documentation
Measured: Up to day 6
Cardiac Arrhythmia - Lengthening QTc
Cardiologist Diagnostic Documentation
Measured: Up to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Mar 2022 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019 Novel CoronavirusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health Jordan
- Sponsor type
- Other government
- Collaborators
- King Hussein Cancer Center, ACDIMA Biocenter, Amman Pharmaceutical Industries, Sana Pharmaceutical Industry
- Responsible party
- Sponsor
- Investigators
- Feras Hawari, MD, Principal investigator, The Jordanian Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113810
- Sponsor's protocol ID
- 1093-2021
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01for the Treatment of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05113810
- Acronym / sponsor ID
- 1093-2021
- Conditions
- 2019 Novel Coronavirus
- Keywords
- COVID-19, Inhaled/nebulized Hydroxychloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ministry of Health JordanOther government
- Collaborators
- King Hussein Cancer Center, ACDIMA Biocenter, Amman Pharmaceutical Industries, Sana Pharmaceutical Industry
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 9 Nov 2021 (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 is a pilot, randomized, single-center, parallel group, open-label controlled study to evaluate the feasibility, safety, efficacy, and pharmacokinetics of nebulized HCQ01 plus Standard of Care (SOC) versus SOC alone in hospitalized COVID-19 patients. The Jordanian Ministry of Health (MOH) is the study sponsor, and the study will be conducted at MOH COVID-19 hospitals.
Approximately 110 patients, ≥18 years of age with a confirmed SARS-CoV-2 infection, will be enrolled and randomized 1:1 to the treatment and control arms where they will receive ten doses of Hydroxychloroquine solution via nebulizer in addition to SOC or the control arm where treatment will follow the MOH SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Arm (Hydroxychloroquine sulfate, 5 days) | Experimental | Drug: HCQ01Participants will receive continued standard of care therapy (SOC) for COVID-19 together with 2 ml HCQ01 (12.5 mg/ml) twice a day for 5 consecutive days. |
| Second Arm (Continued Standard of Care (SOC) Therapy) | Active comparator | Other: standard of care (SOC) for COVID-19Participants will receive continued standard of care therapy for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
- Patients with a history of retinopathy, sickle cell disease or trait, psoriasis, porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder, known active tuberculosis or history of incompletely treated tuberculosis, patients on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants.
- Patients admitted in ICU.
- Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone , cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and during the duration of the study.
- History of Glucose-6-phosphate dehydrogenase deficiency.
Key exclusion criteria (21 listed)
- Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
- Patients with a history of retinopathy, sickle cell disease or trait, psoriasis, porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder, known active tuberculosis or history of incompletely treated tuberculosis, patients on chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants.
- Patients admitted in ICU.
- Taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone , cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and during the duration of the study.
- History of Glucose-6-phosphate dehydrogenase deficiency.
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 |
|---|---|---|
| HCQ01HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization | Drug | First Arm (Hydroxychloroquine sulfate, 5 days) |
| standard of care (SOC) for COVID-19Standard of care (SOC) for COVID-19 | Other | Second Arm (Continued Standard of Care (SOC) Therapy) |
Primary outcome
WHO Ordinal Scale for for Clinical Improvement
Time frame: [ Day -1 (screening) to Days 3,6, and 14 ]
Change in condition measured using the Ordinal Scale for Clinical Improvement. Patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead
10 secondary outcomes
Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI
Time frame: Day 28
All-cause mortality
Time frame: Day 28
HCQ concentration in plasma versus time profiles
Time frame: Day 1 pre-dose (within 1-hour prior dosing) and +2, +5, +10, +15, +20, +25, and +30 minutes after dose, and also +1, +2, +3, +4 and +6 hours post-dose completion
Change from Baseline Oxygenation as determined by the SpO2/FiO2 ratio
Time frame: Days 3 & 6
Rate of Transfer to the Intensive Care Unit
Time frame: Up to day 28
Time to Hospital Discharge or NEWS2 (National Early Warning Score 2) of ≤ 2
Time frame: Up to day 28
Treatment-related adverse events of HCQ
Time frame: Up to day 28
Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia [Time Frame
Time frame: Up to day 6
Cardiac Arrhythmia - Ventricular Tachycardia
Time frame: Up to day 6
Cardiac Arrhythmia - Lengthening QTc
Time frame: Up to day 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Feras Hawari, MD principal investigator
The Jordanian Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HCQ01 in people with 2019 Novel Coronavirus, run by Ministry of Health Jordan at 1 site in Jordan.
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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 7 Mar 2022. 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 Jordan. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Dodin, MSc (00962798950958, YD.14502@KHCC.JO), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO Ordinal Scale for for Clinical Improvement (time frame: [ Day -1 (screening) to Days 3,6, and 14 ]). 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 7 Mar 2022.