NCT04429867

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: WellStar Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-07
• Primary completion: 2020-12-07
• Completion: 2020-12-07
• First posted: 2020-06-12
• Last updated: 2020-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study