Official Title
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Phase
Phase 4Lead Sponsor
WellStar Health SystemStudy Type
InterventionalStatus
Unknown statusIndication/Condition
COVID-19Intervention/Treatment
Hydroxychloroquine ...Study Participants
700The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.
Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Inclusion Criteria: Admitted to Wellstar Kennestone Hospital Age 18 years or older Laboratory-confirmed COVID-19 At least 1 of the following: Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline Bilateral infiltrates on CXR or CT of chest Age 65 or older Diabetes Hypertension BMI > 35 Chronic lung disease Cardiovascular disease Chronic kidney disease Cancer (hematologic malignancies, lung cancer, and metastatic disease) Exclusion Criteria: Unable to provide informed consent Unable to take oral medication Severe/critical COVID-19 disease at presentation Intensive care or intermediate care required at admission or within 48 hours Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours Likelihood of survival <48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission Inability to take hydroxychloroquine due to allergy, QTc > 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions Pregnant or breastfeeding Severe liver disease (Child-Pugh Class C)
