2019 Novel CoronavirusPhase 1/2NCT04731051
The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients
A Phase 1/2 study testing HCQ01 in people with 2019 Novel Coronavirus, run by King Hussein Cancer Center 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 cancer patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 0 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2022to Dec 2022
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the patient and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines.
- Male or female ≥18 years of age at time of enrolment.
- History of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization).
- Eastern Cooperative Oncology Group (ECOG) Status < or = 3 (Appendix I).
- Patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. This includes:
- Patients with a new cancer diagnosis who have not yet initiated cancer therapy.
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- Patients on active or have recently completed cancer-directed therapy including chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal therapy amongst others which would not increase the risk of having an adverse outcome from participating in this study.
- Currently hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) collected within one week prior to randomization.
- Initial COVID-19 severity status on the WHO 11-point Ordinal Scale for Clinical Improvement = 4 ("Hospitalized; no oxygen therapy "), = 5 ("Hospitalized; oxygen by mask or nasal prongs "), or 6 ("Hospitalized; oxygen by NIV or high flow ") (Appendix II).
- COVID-19-induced pneumonia evidenced by chest X-ray, computed tomography scan (CT scan) or magnetic resonance scan (MR scan).
- Estimated life expectancy of at least 6 months at hospital admission for COVID-19.
- Patients must be receiving standard of care for SARS-CoV-2.
- Patients must have an assessment of adequate organ function within 28 days prior to enrolment, evidenced by:
- Hemoglobin ≥ 9.0 g / dL.
- Leukometry> 2,000 / mm3 (> 2 10E3/ ul).
- Absolute neutrophil count ≥ 1,500 / mm3 (≥1.5 10E3/ul).
- Platelet count ≥ 100,000 / mm3 (≥100 10E3/ul).
- Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula.
- Total bilirubin <3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome.
- Aspartate aminotransaminase (AST) <3.0 x LSN.
- Alanine aminotransaminase (ALT) <3.0 x ULN.
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 (<3.6 mg/dl), Hypocalcemia (<8.8 mg/dl), Hypomagnesemia (<1.7 mg/dl). 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.
About this study
Official title: A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer
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 cancer patients with COVID-19. King Hussein Cancer Center (KHCC) is the study sponsor, and the study will be conducted at KHCC COVID-19 wards.
Approximately 28 cancer 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 KHCC SOC.
- Conditions
- 2019 Novel Coronavirus
- Being tested
- HCQ01, standard of care (SOC) for COVID-19
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-19Drug
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; Drug: standard of care (SOC) for COVID-19 |
| Second Arm (Continued Standard of Care (SOC) Therapy) | Active comparator | Participants will receive continued standard of care therapy for COVID-19 Receives: Drug: standard of care (SOC) for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead .
Measured: Time Frame: Day 14
Secondary outcomes (20)
Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI
Measured: Days 5, 28
Change in condition measured using the 11-point WHO-OSCI
Measured: Days 5, 14, 28
All-cause mortality
Measured: Day 28
Hydroxychloroquine (HCQ) concentration in plasma versus time profiles
Measured: Day 1 pre-dose (time 0) 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: Day 5 of treatment
Treatment-related adverse events of HCQ
Incidence and severity of treatment-related adverse events.
Measured: Up to day 28
Rate of Transfer to the Intensive Care Unit
Measured: Up to day 28
Time to Clinical Improvement
time (in days) to improvement in clinical status by at least one level lower on the 11 point WHO-OSCI
Measured: Up to day 28
Duration of hospitalization
Measured: Up to 28 days
Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hrs
Measured: Up to 28 days
Status of discharged or not requiring supplemental oxygen
Measured: Day 14, 28
Rates of Intensive Care Unit mortality
Measured: Day 14, 28
Intensive Care length of stay
Measured: Up to day 28
Oxygenation free days
Measured: Day 14, 28
Ventilator free days
Measured: Day 14, 28
Incidence & duration of new oxygen use
Measured: Day 14, 28
Incidence and duration of new mechanical ventilation use
Measured: Day 14, 28
Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia
Measured: Up to day 28
Cardiac Arrhythmia - Ventricular Tachycardia
Cardiologist Diagnostic Documentation
Measured: Up to day 28
Cardiac Arrhythmia - Lengthening QTc
Cardiologist Diagnostic Documentation
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study startOct 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: the study was terminated as no more COVID cases were treated at the center
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amman Pharmaceutical Industries (API), Sana Pharmaceutical Industry, ACDIMA Biocenter
- Responsible party
- Principal investigator, Feras Hawari, King Hussein Cancer Center
- Investigators
- Feras Hawari, MD, Principal investigator, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731051
- Sponsor's protocol ID
- HYDR0121/CCO
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2021
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. 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 HCQ01 for the Treatment of Patients With COVID-19 and Cancer
- ClinicalTrials.gov ID
- NCT04731051
- Acronym / sponsor ID
- HYDR0121/CCO
- Conditions
- 2019 Novel Coronavirus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study was terminated as no more COVID cases were treated at the center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Collaborators
- Amman Pharmaceutical Industries (API), Sana Pharmaceutical Industry, ACDIMA Biocenter
- Study start
- Oct 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Jan 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 cancer patients with COVID-19. King Hussein Cancer Center (KHCC) is the study sponsor, and the study will be conducted at KHCC COVID-19 wards.
Approximately 28 cancer 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 KHCC 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: HCQ01, Drug: standard of care (SOC) for COVID-19Participants 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 | Drug: 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Documented informed consent of the patient and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines.
- Male or female ≥18 years of age at time of enrolment.
- History of/ or active histologically or cytologically confirmed diagnosis of hematological or solid tumor (any type, any stage and any localization).
- Eastern Cooperative Oncology Group (ECOG) Status < or = 3 (Appendix I).
- Patients must have an active cancer treatment or have completed therapy within 12 months of initiation of protocol specified therapy. This includes:
Key exclusion criteria (23 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 | Drug | First Arm (Hydroxychloroquine sulfate, 5 days), Second Arm (Continued Standard of Care (SOC) Therapy) |
Primary outcome
Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead .
Time frame: Time Frame: Day 14
20 secondary outcomes
Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI
Time frame: Days 5, 28
Change in condition measured using the 11-point WHO-OSCI
Time frame: Days 5, 14, 28
All-cause mortality
Time frame: Day 28
Hydroxychloroquine (HCQ) concentration in plasma versus time profiles
Time frame: Day 1 pre-dose (time 0) 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: Day 5 of treatment
Treatment-related adverse events of HCQ
Time frame: Up to day 28
Rate of Transfer to the Intensive Care Unit
Time frame: Up to day 28
Time to Clinical Improvement
Time frame: Up to day 28
Duration of hospitalization
Time frame: Up to 28 days
Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hrs
Time frame: Up to 28 days
Status of discharged or not requiring supplemental oxygen
Time frame: Day 14, 28
Rates of Intensive Care Unit mortality
Time frame: Day 14, 28
Intensive Care length of stay
Time frame: Up to day 28
Oxygenation free days
Time frame: Day 14, 28
Ventilator free days
Time frame: Day 14, 28
Incidence & duration of new oxygen use
Time frame: Day 14, 28
Incidence and duration of new mechanical ventilation use
Time frame: Day 14, 28
Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia
Time frame: Up to day 28
Cardiac Arrhythmia - Ventricular Tachycardia
Time frame: Up to day 28
Cardiac Arrhythmia - Lengthening QTc
Time frame: Up to day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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
King Hussein Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HCQ01 in people with 2019 Novel Coronavirus, run by King Hussein Cancer Center 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 21 inclusion and 23 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: withdrawn, as of the sponsor's last update on 7 Apr 2023. 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead . (time frame: Time Frame: Day 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 Apr 2023.