COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

Covid19 Clinical Trial

Official title:

COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650087
• Other study ID #: Pro00107078
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2021
• Est. completion date: September 23, 2022

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

Description:

This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days).

The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital.

Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1219
• Est. completion date: September 23, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Age = 18 years

• PCR-positive COVID-19 infection

• Hospitalized for two or more days

Exclusion Criteria:

• Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)

• Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.

• Platelet count < 50,000/mcL

• Hemoglobin <8 gm/dL

• Renal insufficiency (eGFR < 30 mL/min/1.73 m2)

• Pregnancy

• Prison inmate

• Life expectancy less than 90 days

• Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol

• Dual antiplatelet therapy that cannot be discontinued

• Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Thrombosis

Intervention

Drug:
• Apixaban 2.5 MG
Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
• Placebo
Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Emory University	Atlanta	Georgia
United States	AtlantiCare Regional Medical Center	Atlantic City	New Jersey
United States	Medical College of Georgia/Augusta University	Augusta	Georgia
United States	Lifebridge (Sinai Hospital of Baltimore)	Baltimore	Maryland
United States	Bay Regional Medical Center d/b/a/ McLaren Bay Region	Bay City	Michigan
United States	Christus St. Elizabeth Hospital	Beaumont	Texas
United States	Indiana University Health Bloomington Hospital	Bloomington	Indiana
United States	Boston University	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Coney Island Hospital	Brooklyn	New York
United States	NYU Langone Hospital-Brooklyn	Brooklyn	New York
United States	Buffalo General Medical Center	Buffalo	New York
United States	Mercy Hospital Buffalo	Buffalo	New York
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Mercury Street Medical Group	Butte	Montana
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Cook County Health	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The University of Chicago Medicine	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baycare Hospital	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Scott and White Medical Center- College Station	College Station	Texas
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Centura Health Porter Adventist Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke Medical Center	Durham	North Carolina
United States	St. Luke's University Health Network	Easton	Pennsylvania
United States	OSF Little Company of Mary	Evergreen Park	Illinois
United States	Florida Heart Center	Fort Pierce	Florida
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	Texas Health Harris Methodist	Fort Worth	Texas
United States	University of Florida	Gainesville	Florida
United States	East Carolina University/Vidant Health	Greenville	North Carolina
United States	Hawaii Pacific Health	Honolulu	Hawaii
United States	Queens Medical Center	Honolulu	Hawaii
United States	University of Texas- Houston, LBJ Hospital	Houston	Texas
United States	UT Houston MHH-SW	Houston	Texas
United States	UTHouston	Houston	Texas
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Conemaugh Memorial Medical Center	Johnstown	Pennsylvania
United States	Western Michigan University	Kalamazoo	Michigan
United States	Truman Medical Center	Kansas City	Missouri
United States	Kettering Medical Center	Kettering	Ohio
United States	Saint Anthony Hospital	Lakewood	Colorado
United States	Dartmouth Hichcock Medical Center	Lebanon	New Hampshire
United States	Baptist Health Lexington	Lexington	Kentucky
United States	CHI St Elizabeth Hospital	Lincoln	Nebraska
United States	Central Arkansas Veterans Health Care System	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Franciscan Health Michigan City	Michigan City	Indiana
United States	MidMichigan Medical Center	Midland	Michigan
United States	Blood Center of Wisconsin	Milwaukee	Wisconsin
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	McLaren Macomb	Mount Clemens	Michigan
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hope Tower at Jersey Shore University Medical Center	Neptune	New Jersey
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Ochsner Clinic Foundation-Baton Rouge	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	New York University Langone Health	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Stanford University School of Medicine	Palo Alto	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Dignity Health-St Josephs	Phoenix	Arizona
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Texas Health Frisco	Plano	Texas
United States	Maine Medical Center/Maine Medical Partners Adult Hospital Medicine	Portland	Maine
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	MultiCare Institute for Research & Innovation	Puyallup	Washington
United States	Wake Med Hospital	Raleigh	North Carolina
United States	Monument Health Clinical Research	Rapid City	South Dakota
United States	Renown Health	Reno	Nevada
United States	UW Medicine Valley Medical Center	Renton	Washington
United States	Reid Physician Associates	Richmond	Indiana
United States	Pen Bay Medical Center	Rockport	Maine
United States	Adventist HealthCare Shady Grove Medical Center	Rockville	Maryland
United States	Baylor Scott and White-Round Rock	Round Rock	Texas
United States	New Ananda Medical and Urgent Care, Inc.	S. El Monte	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	St Louis University	Saint Louis	Missouri
United States	UCSF at Zuckerberg San Francisco General Hospital	San Francisco	California
United States	Christus St. Vincent Regional Medical Center	Santa Fe	New Mexico
United States	Savannah Health Services, LLC DBA Memorial Health University Medical Center	Savannah	Georgia
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Willis-Knighton Physician Network/Tri-State Medical Clinic	Shreveport	Louisiana
United States	Baystate Medical center	Springfield	Massachusetts
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Tallahassee Memorial HealthCare	Tallahassee	Florida
United States	James A. Haley Veteran's Hospital	Tampa	Florida
United States	Baylor Scott and White-Temple	Temple	Texas
United States	The Woodlands Center For Respiratory & Sleep Research	The Woodlands	Texas
United States	Mazur and Statner MD PC	Thousand Oaks	California
United States	Torrance Medical Center	Torrance	California
United States	Capital Health System, Inc.	Trenton	New Jersey
United States	Ascension St. John Bartlesville	Tulsa	Oklahoma
United States	Ascension St. John Tulsa	Tulsa	Oklahoma
United States	CHRISTUS Trinity Clinic Pulmonary Medicine	Tyler	Texas
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas
United States	UT Health East Texas (Tyler)	Tyler	Texas
United States	Westchester Medical Center	Valhalla	New York
United States	UT Rio Grande Valley	Weslaco	Texas
United States	Tower Health Medical Group	West Reading	Pennsylvania
United States	St. Anthony North Health Campus	Westminster	Colorado
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	BayCare Hospital- Winter Haven	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Thomas L. Ortel	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of all-cause mortality		30 days following discharge from hospital
Other	The incidence of all-cause rehospitalization for up to 90 days after randomization		90 days following discharge from hospital
Other	The individual domains of EQ5D and the EQ5D visual analog scale for 30 and 90 days after randomization		30 and 90 days following discharge from hospital
Primary	Composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records.		30 days after hospital discharge
Secondary	The composite outcome of all-cause mortality and the EQ5D index score.		30 days after hospital discharge
Secondary	The composite outcome of all-cause mortality and the EQ5D index score.		90 days after hospital discharge
Secondary	The composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records.		45 days after hospital discharge
Secondary	The composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records.		90 days after hospital discharge
Secondary	New, symptomatic VTE (inclusive of DVT, PE, or other venous thrombosis) for up to 30 days after randomization as measured by hospital records.		30 days after randomization
Secondary	New, symptomatic ATE (inclusive of ischemic stroke, MI, or peripheral arterial thromboembolism) for up to 30 days after randomization as measured by hospital records.		30 days after randomization