Status:
UNKNOWN
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Lead Sponsor:
WellStar Health System
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2020
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04429867
Start Date
May 7 2020
End Date
December 7 2020
Last Update
June 16 2020
Active Locations (1)
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1
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060