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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04429867

Run by

WellStar Health System

People needed

700

Starts

2020-05-07

Expected to finish

2020-12-07

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Wellstar Kennestone Hospital — Marietta, Georgia, United States

Full record on ClinicalTrials.gov

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