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

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

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

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

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