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.
Drug: Hydroxychloroquine
Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Drug: Placebo
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:
1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from
baseline
2. Bilateral infiltrates on CXR or CT of chest
3. Age 65 or older
4. Diabetes
5. Hypertension
6. BMI > 35
7. Chronic lung disease
8. Cardiovascular disease
9. Chronic kidney disease
10. 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
1. Intensive care or intermediate care required at admission or within 48 hours
2. 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)
Wellstar Kennestone Hospital
Marietta, Georgia, United States