Last reviewed · How we verify

NCT04650087

COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

Completed Phase 3 Results posted Last updated 25 February 2025
What this trial tests

Phase 3 trial testing Apixaban 2.5 MG in Covid19 in 1,291 participants. Completed in 23 September 2022.

Timeline
15 February 2021
Primary endpoint
24 July 2022
23 September 2022

Quick facts

Lead sponsorThomas L. Ortel
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment1,291
Start date15 February 2021
Primary completion24 July 2022
Estimated completion23 September 2022
Sites121 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Thomas L. Ortel

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 30 days after hospital discharge

Composite endpoint (CE) of venous and arterial thrombotic complications-including new, symptomatic proximal, or distal DVT of the upper or lower extremities, PE, and new thrombosis of other veins (including cerebral sinus and splanchnic veins), ischemic stroke, myocardial infarction, other arterial thromboembolism (e.g., mesenteric or acute limb ischemia), and all-cause mortality by day 30.

GroupValue95% CI
Placebo2.311.27 – 3.84
Apixaban2.131.14 – 3.62
The Composite Outcome of All-cause Mortality and the EuroQoL Group 5-Dimension (EQ5D) Index Score. Secondary · 30 days after hospital discharge

Composite endpoint of mortality and EQ5D index at Day 30. All mortality events will be considered worse than any possible EQ5D response \[QOL\&M30\]. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.

GroupValue95% CI
Placebo0.930.78 – 1.00
Apixaban0.930.75 – 1.00
The Composite Outcome of All-cause Mortality and the EQ5D Index Score. Secondary · 90 days after hospital discharge

Composite endpoint of mortality and EQ5D index at Day 90. All mortality events will be considered worse than any possible EQ5D response. Death was designated as a score of 0. Scores range from 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.

GroupValue95% CI
Placebo0.940.76 – 1.00
Apixaban0.940.74 – 1.00
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. Secondary · 45 days after hospital discharge
GroupValue95% CI
Placebo2.801.64 – 4.44
Apixaban2.461.38 – 4.02
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. Secondary · 90 days after hospital discharge
GroupValue95% CI
Placebo2.801.64 – 4.44
Apixaban3.111.89 – 4.82
New, Symptomatic VTE (Inclusive of DVT, PE, or Other Venous Thrombosis) for up to 30 Days After Randomization as Measured by Hospital Records. Secondary · 30 days after randomization (which occurred at time of hospital discharge)
GroupValue95% CI
Placebo0.820.27 – 1.91
Apixaban0.820.27 – 1.90
New, Symptomatic ATE (Inclusive of Ischemic Stroke, MI, or Peripheral Arterial Thromboembolism) for up to 30 Days After Randomization as Measured by Hospital Records. Secondary · 30 days after randomization (which occurred at time of hospital discharge)
GroupValue95% CI
Placebo0.490.10 – 1.44
Apixaban0.160.00 – 0.91
Percentage of Participants With All-cause Mortality Secondary · 30 days following discharge from hospital
GroupValue95% CI
Placebo1.480.68 – 2.80
Apixaban1.310.57 – 2.57

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to the 90 day visit. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Apixaban
Serious: 71/610 (12%)
Deaths: 12/610
Placebo
Serious: 66/607 (11%)
Deaths: 9/607

Serious adverse events (74 terms)

ReactionSystemApixabanPlacebo
WORSENING COVID-19 PNEUMONIAInfections and infestations
PNEUMONIAInfections and infestations
CHEST PAINGeneral disorders
WORSENING PNEUMONIAInfections and infestations
DIABETIC KETO ACIDOSISMetabolism and nutrition disorders
PULMONARY EMBOLIRespiratory, thoracic and mediastinal disorders
C. DIFFICILE COLITISInfections and infestations
CELLULITISInfections and infestations
COPD EXACERBATIONRespiratory, thoracic and mediastinal disorders
DEEP VEIN THROMBOSISVascular disorders
GENERAL WEAKNESSGeneral disorders
PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders
ACUTE APPENDICITISInfections and infestations
ACUTE ASTHMA EXACERBATIONRespiratory, thoracic and mediastinal disorders
ACUTE DIFFUSE MYALGIASMusculoskeletal and connective tissue disorders
ACUTE REJECTION ON TRANSPLANTED KIDNEYImmune system disorders
ALCOHOL DETOXIFICATIONSurgical and medical procedures
APPENDICITISInfections and infestations
ASTHMA EXACERBATIONRespiratory, thoracic and mediastinal disorders
ATRIAL FIBRILLATIONCardiac disorders
ATYPICAL CHEST PAINGeneral disorders
BILATERAL LOWER EXTREMITY CELLULITISInfections and infestations
BILATERAL PULMONARY EMBOLIRespiratory, thoracic and mediastinal disorders
BRONCHIOLITIS OBLITERANS ORGANIZING PNEUMONIARespiratory, thoracic and mediastinal disorders
BRONCHOSPASMRespiratory, thoracic and mediastinal disorders
Other adverse events (124 terms — click to expand)

ReactionSystemApixabanPlacebo
WORSENING COVID-19 PNEUMONIAInfections and infestations
WORSENING PNEUMONIAInfections and infestations
ELEVATED D-DIMERInvestigations
FALLInjury, poisoning and procedural complications
CHEST PAINGeneral disorders
COPD EXACERBATIONRespiratory, thoracic and mediastinal disorders
HEMOPTYSISRespiratory, thoracic and mediastinal disorders
URINARY TRACT INFECTIONInfections and infestations
MOTOR VEHICLE ACCIDENTInjury, poisoning and procedural complications
PLEURISYRespiratory, thoracic and mediastinal disorders
PLEURITIC CHEST PAINRespiratory, thoracic and mediastinal disorders
PNEUMONIAInfections and infestations
RIGHT KNEE PAINMusculoskeletal and connective tissue disorders
RIGHT LOWER EXTREMITY PAINMusculoskeletal and connective tissue disorders
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations
ABDOMINAL PAINGastrointestinal disorders
ABNORMAL BLEEDINGVascular disorders
ACUTE BACTERIAL SINUSITISInfections and infestations
ACUTE PROSTATITISReproductive system and breast disorders
ANEMIABlood and lymphatic system disorders
ANGIONEUROTIC EDEMASkin and subcutaneous tissue disorders
ANXIETYPsychiatric disorders
BACK PAINMusculoskeletal and connective tissue disorders
BALANITISReproductive system and breast disorders
BILATERAL KNEE PAINMusculoskeletal and connective tissue disorders
BILATERAL LEG EDEMAGeneral disorders
BILATERAL LEG PAINMusculoskeletal and connective tissue disorders
BILATERAL LEG SWELLINGGeneral disorders
BILATERAL LOWER EXTREMITY PAINMusculoskeletal and connective tissue disorders
BRADYCARDIACardiac disorders
BRONCHITISInfections and infestations
CELLULITISInfections and infestations
CELLULITIS OF THE RIGHT LOWER EXTREMITYInfections and infestations
CERVICAL RADICULOPATHYNervous system disorders
CHEST TIGHTNESSGeneral disorders
CHOLECYSTITISHepatobiliary disorders
COLITISGastrointestinal disorders
COMMUNITY ACQUIRED PNEUMONIAInfections and infestations
COMPLEX MIGRAINESNervous system disorders
COMPLEX REGIONAL PAIN SYNDROMENervous system disorders

Most-reported serious reactions: WORSENING COVID-19 PNEUMONIA, PNEUMONIA, CHEST PAIN, WORSENING PNEUMONIA, DIABETIC KETO ACIDOSIS, PULMONARY EMBOLI, C. DIFFICILE COLITIS, CELLULITIS.

Data from ClinicalTrials.gov NCT04650087 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.
    Ramacciotti E, Barile Agati L, Calderaro D, Aguiar VCR, et al · · 2022 · cited 183× · PMID 34921756 · DOI 10.1016/s0140-6736(21)02392-8
  2. Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19: JACC State-of-the-Art Review.
    Talasaz AH, Sadeghipour P, Kakavand H, Aghakouchakzadeh M, et al · · 2021 · cited 126× · PMID 33741176 · DOI 10.1016/j.jacc.2021.02.035
  3. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
  4. American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on postdischarge thromboprophylaxis.
    Cuker A, Tseng EK, Nieuwlaat R, Angchaisuksiri P, et al · · 2022 · cited 52× · PMID 34727173 · DOI 10.1182/bloodadvances.2021005945
  5. Late-onset hematological complications post COVID-19: An emerging medical problem for the hematologist.
    Korompoki E, Gavriatopoulou M, Fotiou D, Ntanasis-Stathopoulos I, et al · · 2022 · cited 46× · PMID 34687462 · DOI 10.1002/ajh.26384
  6. Therapeutics for COVID-19 and post COVID-19 complications: An update.
    Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
  7. Implementation of platform trials in the COVID-19 pandemic: A rapid review.
    Vanderbeek AM, Bliss JM, Yin Z, Yap C. · · 2022 · cited 39× · PMID 34793985 · DOI 10.1016/j.cct.2021.106625
  8. 2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
    Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633

Verify or expand the search:

Other trials of Apixaban 2.5 MG

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04650087.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing