The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients
- Conditions
- 2019 Novel Coronavirus
- Interventions
- Drug: standard of care (SOC) for COVID-19
- Registration Number
- NCT04731051
- Lead Sponsor
- King Hussein Cancer Center
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First Arm (Hydroxychloroquine sulfate, 5 days) standard of care (SOC) for COVID-19 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 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.
- Primary Outcome Measures
Name Time Method 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: Day 14
- Secondary Outcome Measures
Name Time Method Oxygenation free days Day 14, 28 Ventilator free days Day 14, 28 Incidence & duration of new oxygen use Day 14, 28 Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia Up to day 28 Cardiac Arrhythmia - Ventricular Tachycardia Up to day 28 Cardiologist Diagnostic Documentation
Cardiac Arrhythmia - Lengthening QTc Up to day 28 Cardiologist Diagnostic Documentation
Proportion of participants who improve by at least one level lower on the 11-point WHO-OSCI Days 5, 28 All-cause mortality Day 28 Rate of Transfer to the Intensive Care Unit Up to day 28 Time to Clinical Improvement Up to day 28 time (in days) to improvement in clinical status by at least one level lower on the 11 point WHO-OSCI
Duration of hospitalization Up to 28 days Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hrs Up to 28 days Status of discharged or not requiring supplemental oxygen Day 14, 28 Rates of Intensive Care Unit mortality Day 14, 28 Intensive Care length of stay Up to day 28 Change in condition measured using the 11-point WHO-OSCI Days 5, 14, 28 Hydroxychloroquine (HCQ) concentration in plasma versus time profiles 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 Day 5 of treatment Treatment-related adverse events of HCQ Up to day 28 Incidence and severity of treatment-related adverse events.
Incidence and duration of new mechanical ventilation use Day 14, 28
Trial Locations
- Locations (1)
King Hussein Cancer Center
🇯🇴Amman, Jordan