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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization
Standard of care (SOC) for COVID-19
Prince Hamza Hospital/ Amman Field Hospital
Amman, Jordan
RECRUITINGWHO 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
Time frame: [ Day -1 (screening) to Days 3,6, and 14 ]
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
Cardiologist Diagnostic Documentation
Time frame: Up to day 6
Cardiac Arrhythmia - Ventricular Tachycardia
Cardiologist Diagnostic Documentation
Time frame: Up to day 6
Cardiac Arrhythmia - Lengthening QTc
Cardiologist Diagnostic Documentation
Time frame: Up to day 6
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