COVID-19Phase 3NCT04498273
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
A Phase 3 study testing Apixaban 2.5 MG, Apixaban 5MG and Aspirin in people with COVID-19, run by Frank C Sciurba at 71 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Apixaban 2.5 MG, Apixaban 5MG and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 657 participants
- Where
- 71 sitesUnited States
- Study dates
- 7 Sep 2020to 5 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19+ in past 14 days
- Platelets > 100,000
- eGFR > 30ml/min
Who cannot join
- Hospitalized
- Contradiction/ other indication for anti-coagulation
- Pregnancy
- Active cancer
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
United States71 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Pharma Tex Research
Amarillo, Texas, 79109
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, 60506
Ascension Seton Medical Center
Austin, Texas, 78752
Baptist Beaumont
Beaumont, Texas, 77030
Brigham & Women's Hospital
Boston, Massachusetts, 02115
UIC - Mile Square
Chicago, Illinois, 60608
Jesse Brown VA
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Olivo Wellness Medical Center
Chicago, Illinois, 60618
University of Chicago
Chicago, Illinois, 60637
Community Care of Clay
Clay, West Virginia, 25043
Pine Ridge Family Medicine
Colorado Springs, Colorado, 80924
UPMC Passavant Cranberry
Cranberry, Pennsylvania, 16066
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 23720
GFC of Southeastern Michigan
Detroit, Michigan, 48202
The Heart and Medical Center
Durant, Oklahoma, 74701
Duke
Durham, North Carolina, 27701
University of Florida at Gainesville
Gainesville, Florida, 32611
Jadestone Clinical Research, LLC
Gaithersburg, Maryland, 20877
University Healthcare Physicians
Harpers Ferry, West Virginia, 25425
Vital Pharma Research
Hialeah, Florida, 33016
Peters Medical Research
High Point, North Carolina, 27262
Hawaii Pacific Health
Honolulu, Hawaii, 96813
McGoven Medical School - UT- Houston
Houston, Texas, 77030
Diversifield Medical Practices
Houston, Texas, 77057
Next Level Urgent Care
Houston, Texas, 77057
Advanced Research for Health Improvement, LLC
Immokalee, Florida, 34142
University of Floridia at Jacksonville
Jacksonville, Florida, 32209
Gundersen Health System
La Crosse, Wisconsin, 54601
Lakeland Regional
Lakeland, Florida, 33805
University of Southern California
Los Angeles, California, 90033
Raritan Bay Primary Care and Cardiology Associates
Matawan, New Jersey, 07747
UPMC McKeesport
McKeesport, Pennsylvania, 15132
Mesquite Regional Internal Medicine
Mesquite, Texas, 75149
Total Research Group LLC
Miami, Florida, 33126
Jackson Memorial
Miami, Florida, 33136
Well Pharma Medical Research
Miami, Florida, 33173
UPMC East
Monroeville, Pennsylvania, 15146
Intermountain Healthcare
Murray, Utah, 84107
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Innovation Clinical Trials
Palmetto Bay, Florida, 33157
Stanford University School of Medicine
Palo Alto, California, 94304
G&S Medical Associates, LLC
Paterson, New Jersey, 07514
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
UPMC Magee
Pittsburgh, Pennsylvania, 15213
UPMC Presby
Pittsburgh, Pennsylvania, 15213
UPMC Mercy
Pittsburgh, Pennsylvania, 15219
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15220
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
UPMC Passavant McCandless
Pittsburgh, Pennsylvania, 15237
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15243
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15243
SRI International
Plymouth, Michigan, 48170
Strong Memorial
Rochester, New York, 14642
Zuckerberg San Francisco General
San Francisco, California, 94143
Olive View-UCLA Medical Center
Sylmar, California, 91342
Bond Community Health Center
Tallahassee, Florida, 32301
Tallahassee Memorial
Tallahassee, Florida, 32308
USF Tampa General Hospital
Tampa, Florida, 33606
Alliance Clinical Research
Tampa, Florida, 33615
Montefiore Medical Center
The Bronx, New York, 10467
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, 74104
University of Texas at Tyler
Tyler, Texas, 75708
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
Life Tree Health, Inc.
Washington D.C., District of Columbia, 20020
University of Texas at Rio Grande Valley
Weslaco, Texas, 78596
Community Care of Weston
Weston, West Virginia, 26452
Ascension Via Christi
Wichita, Kansas, 67214
Metro Health-University of Michigan Health
Wyoming, Michigan, 49519
Spinal Pain and Rehab Medicine
Yonkers, New York, 10701
About this study
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
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 MGDrug
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.
Apixaban 5MGDrug
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.
AspirinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban 2.5mg | Active comparator | Anticoagulation: prophylactic dose Apixaban 2.5mg po bid Receives: Drug: Apixaban 2.5 MG |
| Apixaban 5mg | Active comparator | Anticoagulation: therapeutic dose Apixaban 5.0mg po bid Receives: Drug: Apixaban 5MG |
| Aspirin | Active comparator | Antiplatelet agent: low dose aspirin 81mg po qd Receives: Drug: Aspirin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start7 Sep 2020
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Why it stopped: an event rate lower than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank C Sciurba
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Frank C Sciurba, University of Pittsburgh
- Investigators
- Frank Sciurba, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498273
- Sponsor's protocol ID
- ACTIV4-Outpatient
- Status last verified
- Feb 2022
- First submitted
- 3 Aug 2020
- Last updated
- 17 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
PubMed 37591523Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
PubMed 37489818Bledsoe J, Woller SC, Brooks M, Sciurba FC, Krishnan JA, Martin D, Hou P, Lin JY, Kindzelski A, Handberg E, Kirwan BA, Zaharris E, Castro L, Shapiro NL, Pepine CJ, Majercik S, Fu Z, Zhong Y, Venugopal V, Lai YH, Ridker PM, Connors JM. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial. BMC Infect Dis. 2023 May 15;23(1):325. doi: 10.1186/s12879-023-08295-9.
PubMed 37189091Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272.
PubMed 34633405Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498273
- Acronym / sponsor ID
- ACTIV4-Outpatient
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: an event rate lower than anticipated
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Frank C SciurbaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apixaban 2.5mg | Active comparator | Drug: Apixaban 2.5 MGAnticoagulation: prophylactic dose Apixaban 2.5mg po bid |
| Apixaban 5mg | Active comparator | Drug: Apixaban 5MGAnticoagulation: therapeutic dose Apixaban 5.0mg po bid |
| Aspirin | Active comparator | Drug: AspirinAntiplatelet agent: low dose aspirin 81mg po qd |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19+ in past 14 days
- Platelets > 100,000
- eGFR > 30ml/min
Key exclusion criteria (4 listed)
- Hospitalized
- Contradiction/ other indication for anti-coagulation
- Pregnancy
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban 2.5 MGSubjects 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. | Drug | Apixaban 2.5mg |
| Apixaban 5MGSubjects 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. | Drug | Apixaban 5mg |
| AspirinSubjects 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. | Drug | Aspirin |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37591523Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
- Derived from this study: PubMed 37489818Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
- Derived from this study: PubMed 37189091Bledsoe J, Woller SC, Brooks M, Sciurba FC, Krishnan JA, Martin D, Hou P, Lin JY, Kindzelski A, Handberg E, Kirwan BA, Zaharris E, Castro L, Shapiro NL, Pepine CJ, Majercik S, Fu Z, Zhong Y, Venugopal V, Lai YH, Ridker PM, Connors JM. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial. BMC Infect Dis. 2023 May 15;23(1):325. doi: 10.1186/s12879-023-08295-9.
- Derived from this study: PubMed 34633405Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Sciurba principal investigator
University of Pittsburgh
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban 2.5 MG, Apixaban 5MG and Aspirin in people with COVID-19, run by Frank C Sciurba at 71 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for Cardiovascular/Pulmonary Events (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498273, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.