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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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
King Hussein Cancer Center
Amman, Jordan
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
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
Incidence and severity of treatment-related adverse events.
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 (in days) to improvement in clinical status by at least one level lower on the 11 point WHO-OSCI
Time frame: Up to day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Cardiologist Diagnostic Documentation
Time frame: Up to day 28
Cardiac Arrhythmia - Lengthening QTc
Cardiologist Diagnostic Documentation
Time frame: Up to day 28