COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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
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
Arm | Description | Assigned 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.
|
More Details
- Status
- Terminated
- Sponsor
- Frank C Sciurba
Study Contact
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.