Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

479

Participants

Timeline

Start Date

April 2, 2020

Primary Completion Date

June 19, 2020

Study Completion Date

July 23, 2020

Conditions
CoronavirusAcute Respiratory InfectionSARS-CoV Infection
Interventions
DRUG

Hydroxychloroquine

"Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."

DRUG

Placebo

Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.

Trial Locations (40)

10461

Montefiore Medical Center-Weiler, The Bronx

10467

Montefiore Medical Center-Moses, The Bronx

15261

UPMC Presbyterian/Mercy/Shadyside, Pittsburgh

17033

Penn State Hershey Medical Center, Hershey

19140

Temple University Hospital, Philadelphia

23298

VCU Medical Center, Richmond

27157

Wake Forest Baptist Medical Center, Winston-Salem

29425

Medical University of South Carolina, Charleston

32608

University of Florida, Gainesville

37221

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

40506

University of Kentucky, Lexington

43210

Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Medical Center, Cincinnati

48025

Henry Ford Medical Center, Detroit

48109

University of Michigan Medical Center, Ann Arbor

70112

University Medical Center, New Orleans

77030

University of Texas Health Science Center, Houston

80045

Medical Center of Aurora, Aurora

University of Colorado Hospital, Aurora

80204

Denver Health Medical Center, Denver

80218

St. Joseph Hospital, Denver

84107

Intermountain Medical Center, Murray

84132

University of Utah Hospital, Salt Lake City

85721

University of Arizona, Tucson

90095

Ronald Reagan UCLA Medical Center, Los Angeles

93701

UCSF Fresno, Fresno

94143

UCSF Medical Center, San Francisco

94305

Stanford University, Stanford

95817

UC Davis Medical Center, Sacramento

97239

Oregon Health and Science University, Portland

98104

Harborview Medical Center, Seattle

98122

Swedish Hospital First Hill, Seattle

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

02445

Brigham and Women's Hospital, Boston

01199

Baystate Medical Center, Springfield

01608

St. Vincent's Hospital, Worcester

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Massachusetts General Hospital

OTHER

NCT04332991 - Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease | Biotech Hunter | Biotech Hunter