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NCT04498273 Clinical Trial

COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80

COVID-19 Clinical Trial

Official title:
COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04498273
Other study ID # ACTIV4-Outpatient
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 7, 2020
Est. completion date August 5, 2021

Study information
Verified date February 2022
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis

Description:

The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.

Recruitment information / eligibility
Status Terminated
Enrollment 657
Est. completion date August 5, 2021
Est. primary completion date August 5, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion: - COVID-19+ in past 14 days - Platelets > 100,000 - eGFR > 30ml/min Exclusion: - Hospitalized - Contradiction/ other indication for anti-coagulation - Pregnancy - Active cancer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Apixaban 2.5 MG
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 2.5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
• Apixaban 5MG
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
• Aspirin
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Aspirin twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
• Placebo
Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study placebo will be shipped to subjects home. Subjects will take placebo twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Pharma Tex Research Amarillo Texas
United States Fox Valley Clinical Research Center, LLC Aurora Illinois
United States Ascension Seton Medical Center Austin Texas
United States Baptist Beaumont Beaumont Texas
United States Brigham & Women's Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Jesse Brown VA Chicago Illinois
United States Olivo Wellness Medical Center Chicago Illinois
United States UIC - Mile Square Chicago Illinois
United States University of Chicago Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States Community Care of Clay Clay West Virginia
United States Pine Ridge Family Medicine Colorado Springs Colorado
United States UPMC Passavant Cranberry Cranberry Pennsylvania
United States Midland Florida Clinical Research Center, LLC DeLand Florida
United States GFC of Southeastern Michigan Detroit Michigan
United States The Heart and Medical Center Durant Oklahoma
United States Duke Durham North Carolina
United States University of Florida at Gainesville Gainesville Florida
United States Jadestone Clinical Research, LLC Gaithersburg Maryland
United States University Healthcare Physicians Harpers Ferry West Virginia
United States Vital Pharma Research Hialeah Florida
United States Peters Medical Research High Point North Carolina
United States Hawaii Pacific Health Honolulu Hawaii
United States Diversifield Medical Practices Houston Texas
United States McGoven Medical School - UT- Houston Houston Texas
United States Next Level Urgent Care Houston Texas
United States Advanced Research for Health Improvement, LLC Immokalee Florida
United States University of Floridia at Jacksonville Jacksonville Florida
United States Gundersen Health System La Crosse Wisconsin
United States Lakeland Regional Lakeland Florida
United States University of Southern California Los Angeles California
United States Raritan Bay Primary Care and Cardiology Associates Matawan New Jersey
United States UPMC McKeesport McKeesport Pennsylvania
United States Mesquite Regional Internal Medicine Mesquite Texas
United States Jackson Memorial Miami Florida
United States Total Research Group LLC Miami Florida
United States Well Pharma Medical Research Miami Florida
United States UPMC East Monroeville Pennsylvania
United States Intermountain Healthcare Murray Utah
United States University Medical Center New Orleans New Orleans Louisiana
United States Innovation Clinical Trials Palmetto Bay Florida
United States Stanford University School of Medicine Palo Alto California
United States G&S Medical Associates, LLC Paterson New Jersey
United States OSF Saint Francis Medical Center Peoria Illinois
United States Preferred Primary Care Physicians Pittsburgh Pennsylvania
United States Preferred Primary Care Physicians Pittsburgh Pennsylvania
United States Preferred Primary Care Physicians, Inc Pittsburgh Pennsylvania
United States UPMC Magee Pittsburgh Pennsylvania
United States UPMC Mercy Pittsburgh Pennsylvania
United States UPMC Passavant McCandless Pittsburgh Pennsylvania
United States UPMC Presby Pittsburgh Pennsylvania
United States UPMC Shadyside Pittsburgh Pennsylvania
United States SRI International Plymouth Michigan
United States Strong Memorial Rochester New York
United States Zuckerberg San Francisco General San Francisco California
United States Olive View-UCLA Medical Center Sylmar California
United States Bond Community Health Center Tallahassee Florida
United States Tallahassee Memorial Tallahassee Florida
United States Alliance Clinical Research Tampa Florida
United States USF Tampa General Hospital Tampa Florida
United States Ascension St. John Clinical Research Institute Tulsa Oklahoma
United States University of Texas at Tyler Tyler Texas
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States Life Tree Health, Inc. Washington District of Columbia
United States University of Texas at Rio Grande Valley Weslaco Texas
United States Community Care of Weston Weston West Virginia
United States Ascension Via Christi Wichita Kansas
United States Metro Health-University of Michigan Health Wyoming Michigan
United States Spinal Pain and Rehab Medicine Yonkers New York

Sponsors (2)
Lead Sponsor Collaborator
Frank C Sciurba National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization for Cardiovascular/Pulmonary Events The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment. 45 days
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