Clinical trial NCT04498273: COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-04
Enrollment: 657
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Hospitalization for Cardiovascular/Pulmonary Events
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: Pine Ridge Family Medicine
state: Colorado
city: Washington
country: United States
facility: Life Tree Health, Inc.
state: District of Columbia
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida at Gainesville
state: Florida
city: Hialeah
country: United States
facility: Vital Pharma Research
state: Florida
city: Immokalee
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: Jacksonville
country: United States
facility: University of Floridia at Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional
state: Florida
city: Miami
country: United States
facility: Total Research Group LLC
state: Florida
city: Miami
country: United States
facility: Jackson Memorial
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Clinical Trials
state: Florida
city: Tallahassee
country: United States
facility: Bond Community Health Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial
state: Florida
city: Tampa
country: United States
facility: USF Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Health
state: Hawaii
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Chicago
country: United States
facility: UIC - Mile Square
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Olivo Wellness Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Wichita
country: United States
facility: Ascension Via Christi
state: Kansas
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Gaithersburg
country: United States
facility: Jadestone Clinical Research, LLC
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: GFC of Southeastern Michigan
state: Michigan
city: Plymouth
country: United States
facility: SRI International
state: Michigan
city: Wyoming
country: United States
facility: Metro Health-University of Michigan Health
state: Michigan
city: Matawan
country: United States
facility: Raritan Bay Primary Care and Cardiology Associates
state: New Jersey
city: Paterson
country: United States
facility: G&S Medical Associates, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: Strong Memorial
state: New York
city: Yonkers
country: United States
facility: Spinal Pain and Rehab Medicine
state: New York
city: Durham
country: United States
facility: Duke
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Durant
country: United States
facility: The Heart and Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Ascension St. John Clinical Research Institute
state: Oklahoma
city: Cranberry
country: United States
facility: UPMC Passavant Cranberry
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC East
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presby
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant McCandless
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Amarillo
country: United States
facility: Pharma Tex Research
state: Texas
city: Austin
country: United States
facility: Ascension Seton Medical Center
state: Texas
city: Beaumont
country: United States
facility: Baptist Beaumont
state: Texas
city: Houston
country: United States
facility: McGoven Medical School - UT- Houston
state: Texas
city: Houston
country: United States
facility: Diversifield Medical Practices
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Mesquite
country: United States
facility: Mesquite Regional Internal Medicine
state: Texas
city: Tyler
country: United States
facility: University of Texas at Tyler
state: Texas
city: Weslaco
country: United States
facility: University of Texas at Rio Grande Valley
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Clay
country: United States
facility: Community Care of Clay
state: West Virginia
city: Harpers Ferry
country: United States
facility: University Healthcare Physicians
state: West Virginia
city: Weston
country: United States
facility: Community Care of Weston
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh
name: Frank Sciurba
role: PRINCIPAL_INVESTIGATOR
References:
citation: Connors 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.
citation: Kreuzberger 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.