Purpose

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

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Apixaban 2.5mg
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
  • 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.
Active Comparator
Apixaban 5mg
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
  • Drug: 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.
Active Comparator
Aspirin
Antiplatelet agent: low dose aspirin 81mg po qd
  • Drug: 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 Comparator
Placebo
Placebo
  • Drug: 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.

Recruiting Locations

University of Southern California
Los Angeles, California 90033
Contact:
Sanjay Arora
sanjayar@usc.edu

Stanford University School of Medicine
Palo Alto, California 94304
Contact:
Donald Schreiber
donalds@stanford.edu

Zuckerberg San Francisco General
San Francisco, California 94143
Contact:
Aaron Kornblith
Aaron.Kornblith@ucsf.edu

Olive View-UCLA Medical Center
Sylmar, California 91342
Contact:
Ivan Rokos
irokos@earthlink.net

Midland Florida Clinical Research Center, LLC
DeLand, Florida 23720
Contact:
Godson Oguchi
midlandcrc@gmail.com

University of Florida at Gainesville
Gainesville, Florida 32611
Contact:
Eileen Handberg
Eileen.Handberg@medicine.ufl.edu

Advanced Research for Health Improvement, LLC
Immokalee, Florida 34142
Contact:
Antonio Gonzalez
antonio.gonzalez@arhiusa.com

University of Floridia at Jacksonville
Jacksonville, Florida 32209
Contact:
Dominick Angiolollo
dominick.angiolillo@jax.ufl.edu

Lakeland Regional
Lakeland, Florida 33805
Contact:
Fred Blind, MD
Fred.Blind@myLRH.org

Jackson Memorial
Miami, Florida 33136
Contact:
John Cienki
JCienki@jhsmiami.org

Innovation Clinical Trials
Palmetto Bay, Florida 33157
Contact:
Juan Ruiz Unger
junger@innovationclinicaltrials.com

Bond Community Health Center
Tallahassee, Florida 32301
Contact:
Temple Robinson
trobinson@bondchc.com

Tallahassee Memorial
Tallahassee, Florida 32308
Contact:
Claudia Kroker-Bode
Claudia.Kroker-Bode@tmh.org

USF Tampa General Hospital
Tampa, Florida 33606
Contact:
Jason Wilson, MD
jwilson2@usf.edu

Hawaii Pacific Health
Honolulu, Hawaii 96813
Contact:
Heidi Hillesland
heidi.hillesland@wilcoxhealth.org

Fox Valley Clinical Research Center, LLC
Aurora, Illinois 60506
Contact:
Basharat Muneer
bashmuneer@gmail.com

UIC - Mile Square
Chicago, Illinois 60608
Contact:
Janet Lin
jlin7@uic.edu

Jesse Brown VA
Chicago, Illinois 60612
Contact:
Brendan Steadman
brendan.steadman@va.gov

University of Illinois at Chicago
Chicago, Illinois 60612
Contact:
Janet Lin
JLin7@UIC.EDU

University of Chicago
Chicago, Illinois 60637
Contact:
David Beiser
dbeiser@medicine.bsd.uchicago.edu

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
John Haffner
john.w.hafner@osfhealthcare.org

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Stephen Lim
slim@lsuhsc.edu

Jadestone Clinical Research, LLC
Gaithersburg, Maryland 20877
Contact:
Jonathan Cohen
drjoncohen@gmail.com

Brigham & Women's Hospital
Boston, Massachusetts 02115
Contact:
Peter Hou
PHOU@BWH.HARVARD.EDU

SRI International
Plymouth, Michigan 48170
Contact:
Sascha Goonewardena
sascha.goonewardena@sri.com

Metro Health-University of Michigan Health
Wyoming, Michigan 49519
Contact:
Jeffrey Fletcher
Jeffrey.Fletcher@metrogr.org

Montefiore Medical Center
Bronx, New York 10467
Contact:
Henny Billett
hbillett@montefiore.org

Duke
Durham, North Carolina 27701
Contact:
Rowena Dolor
rowena.dolor@duke.edu

Peters Medical Research
High Point, North Carolina 27262
Contact:
Thomas Jarrett
thomasj@petersmedicalresearch.com

Ascension St. John Clinical Research Institute
Tulsa, Oklahoma 74104
Contact:
Nicholas Hanna
nicholas.hanna@ascension.org

UPMC Passavant Cranberry
Cranberry, Pennsylvania 16066
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

UPMC McKeesport
McKeesport, Pennsylvania 15132
Contact:
Alexandra Weisman
weissmanaj@upmc.edu

UPMC East
Monroeville, Pennsylvania 15146
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

UPMC Magee
Pittsburgh, Pennsylvania 15213
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

UPMC Presby
Pittsburgh, Pennsylvania 15213
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

UPMC Mercy
Pittsburgh, Pennsylvania 15219
Contact:
Alxandra Weissman
weissmanaj@upmc.edu

Preferred Primary Care Physicians
Pittsburgh, Pennsylvania 15220
Contact:
Nathan Bennett
nbennett18@ppcp.org

Preferred Primary Care Physicians
Pittsburgh, Pennsylvania 15220
Contact:
Nathan Bennett
nbennett18@ppcp.org

UPMC Shadyside
Pittsburgh, Pennsylvania 15232
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

UPMC Passavant McCandless
Pittsburgh, Pennsylvania 15237
Contact:
Alexandra Weissman
weissmanaj@upmc.edu

Preferred Primary Care Physicians
Pittsburgh, Pennsylvania 15243
Contact:
Raman Purighalla
rpurighalla@ppcp.org

Ascension Seton Medical Center
Austin, Texas 78752
Contact:
TJ Milling
tjmilling@yahoo.com

Baptist Beaumont
Beaumont, Texas 77030
Contact:
Teddy Wu
Tzu-Ching.Wu@uth.tmc.edu

McGoven Medical School - UT- Houston
Houston, Texas 77030
Contact:
David McPherson
David.D.McPherson@uth.tmc.edu

Next Level Urgent Care
Houston, Texas 77057
Contact:
Wilner Jeudy
wjeudy@nlucc.com

University of Texas at Tyler
Tyler, Texas 75708
Contact:
Patti Olusola
Patti.Olusola@uthct.edu

University of Texas at Rio Grande Valley
Weslaco, Texas 78596
Contact:
Cesar Gutierrez
cesar.gutierrez@utrgv.edu

Intermountain Healthcare
Murray, Utah 84107
Contact:
Sarah Majercik
Sarah.Majercik@imail.org

Community Care of Clay
Clay, West Virginia 25043
Contact:
William Lewis
lewisw@wvumedicine.org

University Healthcare Physicians
Harpers Ferry, West Virginia 25425
Contact:
William Lewis
lewisw@wvumedicine.org

Community Care of Weston
Weston, West Virginia 26452
Contact:
William Lewis
lewisw@wvumedicine.org

More Details

NCT ID
NCT04498273
Status
Recruiting
Sponsor
Frank C Sciurba

Study Contact

Jean Connors
(617) 732-5190
jconnors@bwh.harvard.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.