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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04498273
Enrollment
657
Registered
2020-08-04
Start date
2020-09-07
Completion date
2021-08-05
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief 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

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.

Interventions

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.

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.

DRUGAspirin

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.

DRUGPlacebo

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Frank C Sciurba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Hospitalization for Cardiovascular/Pulmonary Events45 daysThe 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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled from a variety of different facilities where (a) a clinician can evaluate the patient for inclusion and exclusion criteria, and (b) where blood samples can be arranged to be sent for D-dimer, hsCRP, calculated creatinine clearance, and platelet count. COVID-19 testing needs to be confirmed positive within the past 14 days. Serum or urine pregnancy test results will be required for women of childbearing potential before starting study treatment.

Participants by arm

ArmCount
Apixaban 2.5mg
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
165
Apixaban 5mg
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
164
Asprin
Antiplatelet agent: low dose aspirin 81mg po qd
164
Placebo
Only Placebo
164
Total657

Baseline characteristics

CharacteristicApixaban 2.5mgTotalPlaceboAsprinApixaban 5mg
Age, Continuous55 years52 years54 years54 years52 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants3 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants9 Participants2 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
22 Participants78 Participants16 Participants20 Participants20 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants4 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants69 Participants14 Participants22 Participants18 Participants
Race (NIH/OMB)
White
124 Participants494 Participants131 Participants119 Participants120 Participants
Region of Enrollment
United States
165 participants657 participants164 participants164 participants164 participants
Sex: Female, Male
Female
95 Participants388 Participants96 Participants95 Participants102 Participants
Sex: Female, Male
Male
70 Participants269 Participants68 Participants69 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1650 / 1640 / 1640 / 164
other
Total, other adverse events
9 / 16513 / 1646 / 1643 / 164
serious
Total, serious adverse events
0 / 1650 / 1640 / 1640 / 164

Outcome results

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.

Time frame: 45 days

ArmMeasureValue (NUMBER)
Apixaban 2.5mgHospitalization for Cardiovascular/Pulmonary Events1 participants
Apixaban 5mgHospitalization for Cardiovascular/Pulmonary Events1 participants
AsprinHospitalization for Cardiovascular/Pulmonary Events0 participants
PlaceboHospitalization for Cardiovascular/Pulmonary Events0 participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026