The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19
- Conditions
- 2019 Novel Coronavirus
- Interventions
- Other: standard of care (SOC) for COVID-19
- Registration Number
- NCT05113810
- Lead Sponsor
- Ministry of Health Jordan
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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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Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening.
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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.
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Patients admitted in ICU.
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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.
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History of Glucose-6-phosphate dehydrogenase deficiency.
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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).
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Liver Child-Pugh grade C.
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Patients with Hypokalemia (<3.5mmol/L), Hypocalcemia (<2.2mmol/L), Hypomagnesemia (<0.66mmol/L). Will be included after correction.
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Need for mechanical ventilation.
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History of hypersensitivity to hydroxychloroquine.
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History of Chronic Hepatitis B or hepatitis C infections.
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History of Human Immunodeficiency Virus (HIV) infection.
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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.
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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.
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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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First Arm (Hydroxychloroquine sulfate, 5 days) HCQ01 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. Second Arm (Continued Standard of Care (SOC) Therapy) standard of care (SOC) for COVID-19 Participants will receive continued standard of care therapy for COVID-19
- Primary Outcome Measures
Name Time Method WHO Ordinal Scale for for Clinical Improvement [ 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
- Secondary Outcome Measures
Name Time Method Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI Day 28 All-cause mortality Day 28 HCQ concentration in plasma versus time profiles 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 Cardiac Arrhythmia - Lengthening QTc Up to day 6 Cardiologist Diagnostic Documentation
Change from Baseline Oxygenation as determined by the SpO2/FiO2 ratio Days 3 & 6 Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia [Time Frame Up to day 6 Cardiologist Diagnostic Documentation
Rate of Transfer to the Intensive Care Unit Up to day 28 Time to Hospital Discharge or NEWS2 (National Early Warning Score 2) of ≤ 2 Up to day 28 Treatment-related adverse events of HCQ Up to day 28 Cardiac Arrhythmia - Ventricular Tachycardia Up to day 6 Cardiologist Diagnostic Documentation
Trial Locations
- Locations (1)
Prince Hamza Hospital/ Amman Field Hospital
🇯🇴Amman, Jordan