Novel Experimental COVID-19 Therapies Affecting Host Response

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,060

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

October 25, 2023

Study Completion Date

December 31, 2023

Conditions
COVID-19SARS-CoV-2 InfectionCoronavirus Infection
Interventions
DRUG

TXA127

TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.

DRUG

TRV027

TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.

DRUG

Placebo

"NaCl 0.9% infused to match the duration of the agent (3 hours for TXA127 and continuous 24-hour infusion for TRV027, over 30 minutes for APN01.~Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses."

DRUG

Fostamatinib

Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.

Trial Locations (51)

10029

Mount Sinai Hospital, New York

10032

Columbia University Irving Medical Center, New York

10461

Montefiore Medical Center Weiler Campus, The Bronx

10467

Montefiore Medical Center Moses Campus, The Bronx

15213

University of Pittsburgh, Pittsburgh

19140

Temple University Hospital, Philadelphia

20904

Jadestone Clinical Research, LLC, Silver Spring

21224

Johns Hopkins Bayview Medical Center, Baltimore

21287

Johns Hopkins University, Baltimore

22908

UVA Health, Charlottesville

23298

VCU Health, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

27157

Wake Forest University Health Sciences, Winston-Salem

27514

University of North Carolina Medical Center, Chapel Hill

29425

Medical University of South Carolina, Charleston

30303

Ponce de Leon Clinical Research Site, Atlanta

30322

Emory Johns Creek, Atlanta

30342

Emory St. Joseph's Hospital, Atlanta

32610

University of Florida, Gainesville

33136

Public Health Trust of Miami-Dade County, Florida - Jackson Memorial Hospital, Miami

35249

University of Alabama Birmingham, Birmingham

37203

Vanderbilt University Medical Center, Nashville

44111

Cleveland Clinic Fairview Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44321

Cleveland Clinic Akron General, Akron

45069

West Chester Hospital, West Chester

45229

University of Cincinnati, Cincinnati

55415

Hennepin County Medical Center, Minneapolis

60007

Alexian Brothers Medical Center, Elk Grove Village

60169

AMITA Health St. Alexius Medical Center, Hoffman Estates

63110

Washington University, St Louis

68198

University of Nebraska Medical Center, Omaha

70121

Ochsner Clinic Foundation, New Orleans

70808

Our Lady of the Lake Regional Medical Center, Baton Rouge

77030

University of Texas, Houston, Houston

80010

University of Colorado Hospital, Aurora

80204

Denver Health Medical Center, Denver

84107

Intermountain Medical Center, Murray

84108

University of Utah Health, Salt Lake City

85224

Chandler Regional Medical Center, Chandler

87106

University of New Mexico Health Sciences Center, Albuquerque

90048

Cedars-Sinai Medical Center, Los Angeles

94305

Stanford University, Stanford

97239

Oregon Health & Science University, Portland

98104

Harborview Medical Center/University of Washington, Seattle

06510

Yale University, New Haven

02072

Beth Israel Deaconess Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02462

Newton-Wellesley Hospital, Newton

01119

Baystate Health, Springfield

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Sean Collins

OTHER