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
Brief Title
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
COVID-19
Eligibility 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
* COVID-19+ in past 14 days
* Platelets \> 100,000
* eGFR \> 30ml/min
Exclusion:
* Hospitalized
* Contradiction/ other indication for anti-coagulation
* Pregnancy
* Active cancer
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
* COVID-19+ in past 14 days
* Platelets \> 100,000
* eGFR \> 30ml/min
Exclusion:
* Hospitalized
* Contradiction/ other indication for anti-coagulation
* Pregnancy
* Active cancer
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
40 Years
NCT Id
NCT04498273
Org Class
Other
Org Full Name
University of Pittsburgh
Org Study Id
ACTIV4-Outpatient
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Hospitalization for Cardiovascular/Pulmonary Events
Outcome Time Frame
45 days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Henny Billett
Investigator Email
hbillett@montefiore.org
Investigator Phone
718-920-6310