COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

Sponsor

Thomas L. Ortel (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04650087

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

1,223

Enrollment

121

Locations

Arms

17.5

Anticipated Duration (Months)

10.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Apixaban 2.5 MG Drug: Placebo	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

1223 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 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge

Actual Study Start Date :

Feb 15, 2021

Actual Primary Completion Date :

Jun 23, 2022

Anticipated Study Completion Date :

Aug 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records. [30 days after hospital discharge]

Secondary Outcome Measures

The composite outcome of all-cause mortality and the EQ5D index score. [30 days after hospital discharge]
The composite outcome of all-cause mortality and the EQ5D index score. [90 days after hospital discharge]
The composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records. [45 days after hospital discharge]
The composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records. [90 days after hospital discharge]
New, symptomatic VTE (inclusive of DVT, PE, or other venous thrombosis) for up to 30 days after randomization as measured by hospital records. [30 days after randomization]
New, symptomatic ATE (inclusive of ischemic stroke, MI, or peripheral arterial thromboembolism) for up to 30 days after randomization as measured by hospital records. [30 days after randomization]

Other Outcome Measures

The incidence of all-cause mortality [30 days following discharge from hospital]
The incidence of all-cause rehospitalization for up to 90 days after randomization [90 days following discharge from hospital]
The individual domains of EQ5D and the EQ5D visual analog scale for 30 and 90 days after randomization [30 and 90 days following discharge from hospital]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valleywise Health Medical Center	Phoenix	Arizona	United States	85008
2	Dignity Health-St Josephs	Phoenix	Arizona	United States	85013
3	Central Arkansas Veterans Health Care System	Little Rock	Arkansas	United States	72205
4	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
5	Stanford University School of Medicine	Palo Alto	California	United States	94304
6	New Ananda Medical and Urgent Care, Inc.	S. El Monte	California	United States	91733
7	UCSF at Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110
8	Mazur and Statner MD PC	Thousand Oaks	California	United States	91360
9	Torrance Medical Center	Torrance	California	United States	90502
10	Centura Health Porter Adventist Hospital	Denver	Colorado	United States	80210
11	Saint Anthony Hospital	Lakewood	Colorado	United States	80228
12	St. Anthony North Health Campus	Westminster	Colorado	United States	80023
13	Baycare Hospital	Clearwater	Florida	United States	33756
14	Florida Heart Center	Fort Pierce	Florida	United States	34590
15	University of Florida	Gainesville	Florida	United States	32610
16	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
17	Tallahassee Memorial HealthCare	Tallahassee	Florida	United States	32308
18	James A. Haley Veteran's Hospital	Tampa	Florida	United States	33612
19	BayCare Hospital- Winter Haven	Winter Haven	Florida	United States	33881
20	Emory University	Atlanta	Georgia	United States	30308
21	Medical College of Georgia/Augusta University	Augusta	Georgia	United States	30912
22	Savannah Health Services, LLC DBA Memorial Health University Medical Center	Savannah	Georgia	United States	31404
23	Queens Medical Center	Honolulu	Hawaii	United States	96813
24	Hawaii Pacific Health	Honolulu	Hawaii	United States	96827
25	Snake River Research, PLLC	Idaho Falls	Idaho	United States	83404
26	University of Illinois at Chicago	Chicago	Illinois	United States	60607
27	Cook County Health	Chicago	Illinois	United States	60612
28	Rush University Medical Center	Chicago	Illinois	United States	60612
29	The University of Chicago Medicine	Chicago	Illinois	United States	60637
30	OSF Little Company of Mary	Evergreen Park	Illinois	United States	60805
31	Loyola University Medical Center	Maywood	Illinois	United States	60153
32	Indiana University Health Bloomington Hospital	Bloomington	Indiana	United States	47403
33	Lutheran Medical Group	Fort Wayne	Indiana	United States	46804
34	Indiana University Health Methodist Hospital	Indianapolis	Indiana	United States	46202
35	Franciscan Health Michigan City	Michigan City	Indiana	United States	46360
36	Reid Physician Associates	Richmond	Indiana	United States	47374
37	Baptist Health Lexington	Lexington	Kentucky	United States	40503
38	University Medical Center New Orleans	New Orleans	Louisiana	United States	70112
39	Ochsner Clinic Foundation-Baton Rouge	New Orleans	Louisiana	United States	70121
40	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
41	Willis-Knighton Physician Network/Tri-State Medical Clinic	Shreveport	Louisiana	United States	71103
42	Maine Medical Center/Maine Medical Partners Adult Hospital Medicine	Portland	Maine	United States	04102
43	Pen Bay Medical Center	Rockport	Maine	United States	04856
44	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
45	Lifebridge (Sinai Hospital of Baltimore)	Baltimore	Maryland	United States	21215
46	Adventist HealthCare Shady Grove Medical Center	Rockville	Maryland	United States	20850
47	Boston University	Boston	Massachusetts	United States	02118
48	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805
49	Baystate Medical center	Springfield	Massachusetts	United States	01199
50	Bay Regional Medical Center d/b/a/ McLaren Bay Region	Bay City	Michigan	United States	48708
51	Henry Ford Hospital	Detroit	Michigan	United States	48202
52	Western Michigan University	Kalamazoo	Michigan	United States	49008
53	MidMichigan Medical Center	Midland	Michigan	United States	48670
54	McLaren Macomb	Mount Clemens	Michigan	United States	48043
55	Minneapolis VA Health Care System	Minneapolis	Minnesota	United States	55417
56	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
57	Truman Medical Center	Kansas City	Missouri	United States	64108
58	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
59	St Louis University	Saint Louis	Missouri	United States	63110
60	Mercury Street Medical Group	Butte	Montana	United States	59701
61	CHI St Elizabeth Hospital	Lincoln	Nebraska	United States	68510
62	Renown Health	Reno	Nevada	United States	89502
63	Dartmouth Hichcock Medical Center	Lebanon	New Hampshire	United States	03756
64	AtlantiCare Regional Medical Center	Atlantic City	New Jersey	United States	08401
65	Hope Tower at Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
66	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
67	Capital Health System, Inc.	Trenton	New Jersey	United States	08638
68	Christus St. Vincent Regional Medical Center	Santa Fe	New Mexico	United States	87505
69	Montefiore Medical Center	Bronx	New York	United States	10467
70	NYU Langone Hospital-Brooklyn	Brooklyn	New York	United States	111220
71	Coney Island Hospital	Brooklyn	New York	United States	11235
72	Buffalo General Medical Center	Buffalo	New York	United States	14203
73	Mercy Hospital Buffalo	Buffalo	New York	United States	14220
74	Jamaica Hospital Medical Center	Jamaica	New York	United States	11418
75	New York University Langone Health	New York	New York	United States	10016
76	Stony Brook University Hospital	Stony Brook	New York	United States	11794
77	Westchester Medical Center	Valhalla	New York	United States	10595
78	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
79	Duke Medical Center	Durham	North Carolina	United States	27710
80	East Carolina University/Vidant Health	Greenville	North Carolina	United States	27858
81	Wake Med Hospital	Raleigh	North Carolina	United States	27610
82	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
83	Summa Health	Akron	Ohio	United States	44304
84	University of Cincinnati	Cincinnati	Ohio	United States	45267
85	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
86	Ohio State University	Columbus	Ohio	United States	43210
87	Kettering Medical Center	Kettering	Ohio	United States	45429
88	Ascension St. John Bartlesville	Tulsa	Oklahoma	United States	74104
89	Ascension St. John Tulsa	Tulsa	Oklahoma	United States	74104
90	Oregon Health and Science University	Portland	Oregon	United States	97239
91	St. Luke's University Health Network	Easton	Pennsylvania	United States	18045
92	Conemaugh Memorial Medical Center	Johnstown	Pennsylvania	United States	15905
93	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
94	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
95	Tower Health Medical Group	West Reading	Pennsylvania	United States	19611
96	Rhode Island Hospital	Providence	Rhode Island	United States	02903
97	The Miriam Hospital	Providence	Rhode Island	United States	02906
98	Monument Health Clinical Research	Rapid City	South Dakota	United States	57701
99	Erlanger Health System	Chattanooga	Tennessee	United States	37403
100	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
101	Christus St. Elizabeth Hospital	Beaumont	Texas	United States	77702
102	Baylor Scott and White Medical Center- College Station	College Station	Texas	United States	77845
103	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
104	Texas Health Harris Methodist	Fort Worth	Texas	United States	76104
105	University of Texas- Houston, LBJ Hospital	Houston	Texas	United States	77030
106	UT Houston MHH-SW	Houston	Texas	United States	77030
107	UTHouston	Houston	Texas	United States	77030
108	Texas Health Frisco	Plano	Texas	United States	75024
109	Baylor Scott and White-Round Rock	Round Rock	Texas	United States	78665
110	Baylor Scott and White-Temple	Temple	Texas	United States	76508
111	The Woodlands Center For Respiratory & Sleep Research	The Woodlands	Texas	United States	77380
112	CHRISTUS Trinity Clinic Pulmonary Medicine	Tyler	Texas	United States	75701
113	The University of Texas Health Science Center at Tyler	Tyler	Texas	United States	75708
114	UT Health East Texas (Tyler)	Tyler	Texas	United States	75708
115	UT Rio Grande Valley	Weslaco	Texas	United States	78596
116	MultiCare Institute for Research & Innovation	Puyallup	Washington	United States	98372
117	UW Medicine Valley Medical Center	Renton	Washington	United States	98055
118	Virginia Mason Medical Center	Seattle	Washington	United States	98101
119	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
120	West Virginia University Hospital	Morgantown	West Virginia	United States	26506
121	Blood Center of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Thomas L. Ortel
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Tracy Wang, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas L. Ortel, Professor, Duke University

ClinicalTrials.gov Identifier:

NCT04650087

Other Study ID Numbers:

Pro00107078

First Posted:

Dec 2, 2020

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Thrombosis

Apixaban

Study Results

No Results Posted as of Jul 7, 2022