The 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
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
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
Time frame: 30 Days
Hospital length of stay
Time frame: 30 Days
30-Day Mortality
Time frame: 30 Days
Resolution of Symptoms
Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
Time frame: 14 Days
Incidence of QTc >500ms after initiation of therapy
Time frame: 30 Days
Incidence of discontinuation of therapy
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.