Official Title
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Brief Summary

The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.

Detailed Description

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.

Unknown status
COVID-19

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

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Wellstar Kennestone Hospital
Marietta, Georgia, United States

WellStar Health System
NCT Number
MeSH Terms
COVID-19
Hydroxychloroquine