Purpose

A multicenter, adaptive, randomized platform trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • Age ≥ 18 years - PCR-positive COVID-19 infection - Hospitalized for two or more days

Exclusion Criteria

  • Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve) - Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months. - Platelet count < 50,000/mcL - Hemoglobin <8 gm/dL - Renal insufficiency (eGFR < 30 mL/min/1.73 m2) - Pregnancy - Prison inmate - Life expectancy less than 90 days - Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol - Dual antiplatelet therapy that cannot be discontinued - Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double Blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Apixaban
Drug: Apixaban 2.5 MG Participants will be given study medication at the time of discharge from the hospital. Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
  • Drug: Apixaban 2.5 MG
    Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
    Other names:
    • Eliquis
Placebo Comparator
Placebo
Drug: Placebo Participants will be given study medication at the time of discharge from the hospital. Participants will take the Placebo twice a day, once in the morning and once in the evening, for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and contact will continue up to day 90 after starting study treatment. Follow up will be through electronic and/or telephone contact depending on the participant's preference, compliance, and medication adherence. Participants will be queried for any clinically relevant endpoints, especially major bleeding or a need to seek healthcare attention for any reason. Follow-up will occur from the time of discharge and through the 30 day study period, with contacts 2 days, 10 days, 20 days, and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
  • Drug: Placebo
    Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.

Recruiting Locations

Valleywise Health Medical Center
Phoenix, Arizona 85008
Contact:
Michael White, MD
602-344-5503
michael.white@valleywisehealth.org

Dignity Health-St Josephs
Phoenix, Arizona 85013
Contact:
Omar Gonzalez, MD
602-406-5861
omar.gonzalez@dignityhealth.org

Central Arkansas Veterans Health Care System
Little Rock, Arkansas 72205
Contact:
Mohammed Moursi, MD
501-257-6906
mmmoursi@uams.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Nikhil Meena, MD
501-686-5526
nkmeena@uams.edu

National Institute of Clinical Research, Inc. Healthcare System 2000
Garden Grove, California 92844
Contact:
Michael Dao, MD
714-531-7830
mdao@nicresearch.com

Emanate Health (Reddy Medical Center)
Pomona, California 91768
Contact:
Mallu Reddy, MD
323-725-0657
mreddy@nicresearch.com

New Ananda Medical and Urgent Care, Inc.
S. El Monte, California 91733
Contact:
Nagasamudra Ashok, MD
323-206-5544
rdudley@nicresearch.com

UCSF at Zuckerberg San Francisco General Hospital
San Francisco, California 94110
Contact:
Mary Knudson, MD
628-206-4626
Peggy.knudson@ucsf.edu

Mazur and Statner MD PC
Thousand Oaks, California 91360
Contact:
Ramesh Nathan, MD
310-890-2713
nathanrv@ah.org

Torrance Medical Center
Torrance, California 90502
Contact:
James McKinnell, MD
310-325-9110
james.mckinnell@tmmc.com

Penrose Hospital
Colorado Springs, Colorado 80907
Contact:
Michael Roshon, MD
719-776-6550
michaelroshon@centura.org

St. Francis Medical Center
Colorado Springs, Colorado 80923
Contact:
Elizabeth Kleiner, MD
719-776-6550
betsykl@comcast.net

Centura Health Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Kathryn Springer, MD
303-765-3536
kathryn.springer@comcast.net

Saint Anthony Hospital
Lakewood, Colorado 80228
Contact:
Rebecca Vogel, MD
720-321-8080
rebeccavogel@centura.org

St. Anthony North Health Campus
Westminster, Colorado 80023
Contact:
Sharry Veres, MD
303-430-5560
sharryveres@centura.org

Baycare Hospital
Clearwater, Florida 33756
Contact:
Leslie Miller, MD
727-462-3701
leslie.miller@baycare.org

Florida Heart Center
Fort Pierce, Florida 34590
Contact:
Prasad Chalasani, MD
772-465-4499
pchalasani@hotmail.com

University of Florida
Gainesville, Florida 32610
Contact:
Lisa Merck, MD
352-265-5911
lmerck@ufl.edu

Mount Sinai Medical Center
Miami Beach, Florida 33140
Contact:
Gervasio Lamas, MD
305-674-3936
gervasio.lamas@msmc.com

Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
Contact:
Janice Lawson, MD
850-431-0558
janice.lawson@tmh.org

BayCare Hospital- Winter Haven
Winter Haven, Florida 33881
Contact:
Kollagunta Chandrasekhar, MD
863-508-1101
kollagunta.chandrasekhar@baycare.org

Emory University
Atlanta, Georgia 30308
Contact:
Manila Gaddh, MD
404-778-3581
manila.gaddh@emory.edu

Medical College of Georgia/Augusta University
Augusta, Georgia 30912
Contact:
Jose Vazquez, MD
706-721-1244
jvazquez@augusta.edu

Savannah Health Services, LLC DBA Memorial Health University Medical Center
Savannah, Georgia 31404
Contact:
Mary Downing, MD
912-350-0414
Mary.Downing@hcahealthcare.com

Queens Medical Center
Honolulu, Hawaii 96813
Contact:
Kuo-Chiang Lian, MD
808-931-9433
klian@queens.org

Hawaii Pacific Health
Honolulu, Hawaii 96827
Contact:
Wade Kyono, MD
808-983-8551
Wade.kyono@hphmg.org

Snake River Research, PLLC
Idaho Falls, Idaho 83404
Contact:
Richard Nathan, MD
208-535-8404
rnathan@snakerr.com

University of Illinois at Chicago
Chicago, Illinois 60607
Contact:
John Quigley, MD
312-355-1625
seanq@uic.edu

Cook County Health
Chicago, Illinois 60612
Contact:
Saurabh Malhotra, MD
312-864-3039
saurabh.malhotra@cookcountyhhs.org

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Shivi Jain, MD
312-226-2371
shivi_jain@rush.edu

The University of Chicago Medicine
Chicago, Illinois 60637
Contact:
Jonathan Paul, MD
312-310-7948
jpaul@medicine.bsd.uchicago.edu

OSF Little Company of Mary
Evergreen Park, Illinois 60805
Contact:
M. Bassel Atassi, MD
708-229-6020
mbassel.atassi@osfhealthcare.org

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Anthi Katsouli, MD
312-888-6643
Anthi.Katsouli@lumc.edu

Indiana University Health Bloomington Hospital
Bloomington, Indiana 47403
Contact:
Dr. Allison Kaderabek, MD
812-353-2831
akaderabek@iuhealth.org

Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202
Contact:
Warren Gavin, MD
317-962-3925
wgavin@IUHealth.org

Franciscan Health Michigan City
Michigan City, Indiana 46360
Contact:
Dafer AL-Haddadin, MD
219-861-5723
dafer.alhaddadin@franciscalliance.org

Reid Physician Associates
Richmond, Indiana 47374
Contact:
John McGinty, MD
765-962-1337
mcgintje@yahoo.com

Baptist Health Lexington
Lexington, Kentucky 40503
Contact:
Andrew Alexander, MD
859-277-4005
dralexander@lexidc.com

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Matthew Lammi, MD
504-568-4634
mlammi@lsuhsc.edu

Ochsner Clinic Foundation-Baton Rouge
New Orleans, Louisiana 70121
Contact:
Mark Effron, MD
504-842-4135
mark.effron@ochsner.org

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
Mark Effron, MD
504-842-4135
mark.effron@ochsner.org

Willis-Knighton Physician Network/Tri-State Medical Clinic
Shreveport, Louisiana 71103
Contact:
Anthony Stuart, MD
318-621-2929
anthonystuart@comcast.net

Maine Medical Center/Maine Medical Partners Adult Hospital Medicine
Portland, Maine 04102
Contact:
Daniel Meyer, MD
207-662-4678
meyerd@mmc.org

Pen Bay Medical Center
Rockport, Maine 04856
Contact:
Robert Stein, MD
207-301-8959
RStein@pbmc.org

Anne Arundel Medical Center
Annapolis, Maryland 21401
Contact:
Barry Meisenberg, MD
443-481-5824
Meisenberg@aahs.org

Lifebridge (Sinai Hospital of Baltimore)
Baltimore, Maryland 21215
Contact:
Paul Gurbel, MD
410-601-9467
mgesheff@lifebridgehealth.org

Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland 20850
Contact:
Jonathan Cohen, MD
240-826-6167
drjoncohen@gmail.com

Boston University
Boston, Massachusetts 02118
Contact:
Naomi Hamburg, MD
617-894-0855
nhamburg@bu.edu

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Julie M Freiman, MD
781-744-8124
julie.m.freiman@lahey.org

Baystate Medical center
Springfield, Massachusetts 01199
Contact:
Paul Pirraglia, MD
413-794-4147
paul.pirraglia@baystatehealth.org

Bay Regional Medical Center d/b/a/ McLaren Bay Region
Bay City, Michigan 48708
Contact:
Elizabeth Pionk, DO
989-894-3297
elizabeth.pionk@mclaren.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Scott Kaatz, MD
313-916-8144
skaatz1@hfhs.org

Western Michigan University
Kalamazoo, Michigan 49008
Contact:
Thomas Blok, MD
269-337-4264
Thomas.blok@med.wmich.edu

MidMichigan Medical Center
Midland, Michigan 48670
Contact:
John Blamoun, MD
989-631-2469
blamounpi@midmichigan.org

McLaren Macomb
Mount Clemens, Michigan 48043
Contact:
Mark Zainea, MD
mzainea@cardofmich.com

Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
Contact:
Ken Kunisaki, MD
612-467-4439
ken.kunisaki@va.gov

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Matthew Kutcher, MD
415-846-0856
mkutcher@umc.edu

Truman Medical Center
Kansas City, Missouri 64108
Contact:
Baweja Paramdeep, MD
816-404-1221
Paramdeep.baweja@tmcmed.org

Barnes-Jewish Hospital
Saint Louis, Missouri 63110
Contact:
Kristen Sanfilippo, MD, MPHS
314-362-0233
ksanfilippo@wustl.edu

Mercury Street Medical Group
Butte, Montana 59701
Contact:
John Pullman, MD
406-723-1300
john.pullman@mercurystmed.com

CHI St Elizabeth Hospital
Lincoln, Nebraska 68510
Contact:
Paul Gabbo, MD
402-219-7910
pgobbo@stez.org

Renown Health
Reno, Nevada 89502
Contact:
Farah Madhani-Lovely, MD
775-982-6911
FMadhani-Lovely@renown.org

AtlantiCare Regional Medical Center
Atlantic City, New Jersey 08401
Contact:
Anthony Macchiavelli, MD
609-225-2226
Anthony.Macchiavelli@atlanticare.org

Hope Tower at Jersey Shore University Medical Center
Neptune, New Jersey 07753
Contact:
David Kountz, MD
732-894-1171
david.kountz@hmhn.org

Newark Beth Israel Medical Center
Newark, New Jersey 07112
Contact:
Alice Cohen, MD
336-580-0070
Alice.Cohen@rwjbh.org

Capital Health System, Inc.
Trenton, New Jersey 08638
Contact:
Marc Whitman, MD
mwhitman@capitalhealth.org

Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico 87505
Contact:
Theresa Ronan, MD
505-983-3361
Theresa.Ronan@stvin.org

Montefiore Medical Center
Bronx, New York 10467
Contact:
Henry Billett, MD
718-920-4137
hbillett@montefiore.org

NYU Langone Hospital-Brooklyn
Brooklyn, New York 111220
Contact:
Aaron Lord, MD
646-596-1099
aaron.lord@nyulangone.org

Coney Island Hospital
Brooklyn, New York 11235
Contact:
George Juang, MD
516-286-6576
George.Juang@nychhc.org

Buffalo General Medical Center
Buffalo, New York 14203
Contact:
Alberto Monegro, MD
716-859-2271
amonegro@buffalo.edu

Mercy Hospital Buffalo
Buffalo, New York 14220
Contact:
Raed Alnaji, MD
716-697-1643
rmalnaji@buffalo.edu

Jamaica Hospital Medical Center
Jamaica, New York 11418
Contact:
Khalid Gafoor, DO
718-206-6742
kgafoor@jhmc.org

New York University Langone Health
New York, New York 10016
Contact:
Shari Brosnahan, MD
241-587-0099
Shari.rosnahan@nyulangone.org

Stony Brook University Hospital
Stony Brook, New York 11794
Contact:
Wadie Bahjou, MD
631-638-3885
mbajwa@mphcc.com

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Raj Kasthuri, MD
919-843-6811
rajkasthuri@med.unc.edu

Duke Medical Center
Durham, North Carolina 27710
Contact:
Lana Wahid, MD
757-509-8162
lana.wahid@duke.edu

East Carolina University/Vidant Health
Greenville, North Carolina 27858
Contact:
James Powell, MD
252-744-2577
powellj@ecu.edu

Wake Med Hospital
Raleigh, North Carolina 27610
Contact:
Judson Williams, MD
919-231-6333
judwilliams@wakemed.org

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
Contact:
Peter J Miller, MD
336-716-4498
pemiller@wakehealth.edu

Summa Health
Akron, Ohio 44304
Contact:
Michael Tan, MD
330-375-7320
TanM@summahealth.org

University of Cincinnati
Cincinnati, Ohio 45267
Contact:
Jean Elwing, MD
513-475-8325
elwingj@ucmail.uc.edu

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Keith McCrae, MD
216-444-7809
mccraek@ccf.org

Ohio State University
Columbus, Ohio 43210
Contact:
Eric Kraut, MD
614-293-2887
eric.kraut@osumc.edu

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Harvey Hahn, MD
937-395-8320
Harvey.Hahn@ketteringhealth.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Akram Khan, MD
503-494-1620
khana@ohsu.edu

St. Luke's University Health Network
Easton, Pennsylvania 18045
Contact:
Douglas Corwin, MD
484-526-3890
Douglas.Corwin@sluhn.org

Conemaugh Memorial Medical Center
Johnstown, Pennsylvania 15905
Contact:
Didar UL Alam, MD
didar.alam@apogeephysicians.com

Temple University Hospital
Philadelphia, Pennsylvania 19140
Contact:
Michael Bromberg, MD
215-707-6356
Michael.Bromberg@tuhs.temple.edu

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Alexandra Weissman, MD
412-864-2284
weissmanaj@upmc.edu

Tower Health Medical Group
West Reading, Pennsylvania 19611
Contact:
Daniel Forman, DO
daniel.forman@towerhealth.org

Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Ralph Rogers, MD
401-444-0968
rrogers@lifespan.org

The Miriam Hospital
Providence, Rhode Island 02906
Contact:
Ralph Rogers, MD
401-444-0968
rrogers@lifespan.org

Monument Health Clinical Research
Rapid City, South Dakota 57701
Contact:
Matthew Anderson, MD
605-755-4326
mhcranderson@monument.health

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Benjamin Tillman, MD
615-875-3810
benjamin.f.tillman@vumc.org

Christus St. Elizabeth Hospital
Beaumont, Texas 77702
Contact:
Amad Waqar, MD
337-430-3193
waqar.ahmad@christushealth.org

Baylor Scott and White Medical Center- College Station
College Station, Texas 77845
Contact:
Timothy Byrd, MD
979-207-0475
timothy.byrd@BSWHealth.org

University of Texas Southwestern Medical Center
Dallas, Texas 75390
Contact:
Sonja Stutzman, MD
214-648-6719
sonja.stutzman@UTSouthwestern.edu

University of Texas- Houston, LBJ Hospital
Houston, Texas 77030
Contact:
Bela Patel, MD
713-500-6835
bela.patel@uth.tmc.edu

UT Houston MHH-SW
Houston, Texas 77030
Contact:
Bela Patel, MD
713-500-6831
bela.patel@uth.tmc.edu

UTHouston
Houston, Texas 77030
Contact:
David McPherson, MD
713-500-6595
david.d.mcpherson@uth.tmc.edu

Baylor Scott and White-Round Rock
Round Rock, Texas 78665
Contact:
MaryAnn Tran, MD
512-509-0200
MaryAnn.Tran@bswhealth.org

Baylor Scott and White-Temple
Temple, Texas 76508
Contact:
Monish Sheth, MD
254-724-5861
monish.sheth@bswhealth.org

The Woodlands Center For Respiratory & Sleep Research
The Woodlands, Texas 77380
Contact:
Moshin Bajwa, MD
346-345-2402
mbajwa@mphcc.com

CHRISTUS Trinity Clinic Pulmonary Medicine
Tyler, Texas 75701
Contact:
Suman Sinha, MD
906-606-3000
suman.sinha@christushealth.org

The University of Texas Health Science Center at Tyler
Tyler, Texas 75708
Contact:
Chiagozie Nwasuruba, MD
903-877-7380
Chiagozie.Nwasuruba@uthct.edu

UT Health East Texas (Tyler)
Tyler, Texas 75708
Contact:
Chiagoze Nwasuruba, MD
903-877-7380
chiagozie.nwasuruba@uthct.edu

UT Rio Grande Valley
Weslaco, Texas 78596
Contact:
Timothy Heath, MD
956-342-5558
timothy.heath@utrgv.edu

MultiCare Institute for Research & Innovation
Puyallup, Washington 98372
Contact:
Vinay Malhorta, MD
vmalhotra@multicare.org

UW Medicine Valley Medical Center
Renton, Washington 98055
Contact:
Michael Previti, MD
Michael_Previti@valleymed.org

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
David Aboulafia, MD
206-223-6193
David.Aboulafia@virginiamason.org

CAMC Clinical Trials Center
Charleston, West Virginia 25304
Contact:
Stephen Lewis, MD
304-388-9944
kristi.sutphin@camc.org

West Virginia University Hospital
Morgantown, West Virginia 26506
Contact:
Troy Krupica, MD
304-293-1964
tkrupica@hsc.wvu.edu

Blood Center of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Lisa Baumann Kreuziger, MD
414-937-6826
lisakreuziger@versiti.org

More Details

NCT ID
NCT04650087
Status
Recruiting
Sponsor
Thomas L. Ortel

Study Contact

Tracy Wang, MD
919-668-8907
tracy.wang@duke.edu

Detailed Description

This study is an adaptive, prospective, randomized platform trial designed to compare the effectiveness and safety of antithrombotic therapy with no antithrombotic therapy after hospitalization for 48 hours or longer for COVID-19. For Stage 1 of this study, participants will be randomized to either prophylactic anticoagulation or matching placebo for 30 days, and then followed for an additional 60 days after the completion of treatment (total duration of follow-up, 90 days). The primary objective is to determine the most effective and safe antithrombotic strategy to prevent the composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality by 30 days following discharge from the hospital. Biobanking of samples for future biomarker and mechanistic studies will be available for centers able to participate and collect samples from eligible participants. Samples will be collected at the time of enrollment and after the completion of 30 days of therapy

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.