Trial record 2 of 3 for:
apixaban | Covid19 | United States
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04498273 |
|
Recruitment Status :
Terminated
(an event rate lower than anticipated)
First Posted : August 4, 2020
Results First Posted : February 17, 2022
Last Update Posted : February 17, 2022
|
Sponsor:
Frank C Sciurba
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank C Sciurba, University of Pittsburgh
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Apixaban 2.5 MG Drug: Apixaban 5MG Drug: Aspirin Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 657 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blind |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | September 7, 2020 |
| Actual Primary Completion Date : | August 5, 2021 |
| Actual Study Completion Date : | August 5, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Apixaban
| Arm | Intervention/treatment |
|---|---|
|
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. |
Primary Outcome Measures :
- Hospitalization for Cardiovascular/Pulmonary Events [ Time Frame: 45 days ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498273
Locations
Show 71 study locations
Sponsors and Collaborators
Frank C Sciurba
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Frank Sciurba | University of Pittsburgh |
Study Documents (Full-Text)
Documents provided by Frank C Sciurba, University of Pittsburgh:
Documents provided by Frank C Sciurba, University of Pittsburgh:
Study Protocol [PDF] May 31, 2021
Statistical Analysis Plan [PDF] May 31, 2021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Frank C Sciurba, Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT04498273 |
| Other Study ID Numbers: |
ACTIV4-Outpatient |
| First Posted: | August 4, 2020 Key Record Dates |
| Results First Posted: | February 17, 2022 |
| Last Update Posted: | February 17, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
COVID-19 Apixaban Thrombosis Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors |