Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Purpose
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Hydroxychloroquine |
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT04429867
- Status
- Unknown status
- Sponsor
- WellStar Health System
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.