Skip to main content
. 2023 Aug 16;2023(8):CD015102. doi: 10.1002/14651858.CD015102.pub2

NCT04746339.

Study name Apixaban for prophylaxis of thromboembolic outcomes in COVID‐19 (APOLLO)
Methods Prospective, multicentre, quadruple‐blind RCT
Participants Number of participants: 1000
Age: ≥ 18 years
Gender: male and female
Inclusion criteria
  • Outpatients with symptomatic laboratory‐proven diagnosis of COVID‐19 (any exam that shows acute infection as positive PCR or IgM in the context of acute symptoms ≤ 10 days) AND

  • Negative pregnancy test for women in childbearing period

  • D‐dimer level ≥ 2 x ULN or

  • C‐reactive protein ≥ 10 mg/L or

  • At least 2 of the following risk factors:

    • D‐dimer level ≥ ULN

    • C‐reactive protein ≥ ULN

    • Age ≥ 65

    • Diabetes

    • Chronic kidney disease stage 3

    • Cardiopulmonary disease (e.g. PAD, CAD, heart failure, COPD)

    • History of PE/DVT

    • Nursing home/skilled nursing facility resident or severely restricted mobility

    • BMI ≥ 30 kg/m2


Exclusion criteria
  • Age < 18 years

  • Patients with indication for full anticoagulation during inclusion (e.g. diagnosis of VTE, atrial fibrillation, MVP)

  • Platelets < 50,000/mm3

  • Use of acetylsalicylic acid > 100 mg per day

  • Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)

  • Chronic use of non‐steroidal anti‐inflammatory drugs

  • Hypersensitivity to apixaban

  • Creatinine clearance < 30 mL/min

  • Pregnancy or breastfeeding

  • Contraindication to anticoagulation (active bleeding, recent major surgery, blood dyscrasia, or prohibitive haemorrhage risk as evaluated by the investigator)

  • A history of haemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous malformation, or aneurysm

  • Use of strong inhibitors of CYP P450 3A4 and/or P‐gp (e.g. protease inhibitors, ketoconazole, itraconazole) and/or use of P‐gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's wort)

Interventions Intervention: apixaban 2.5 mg twice daily for 30 days
Control: placebo twice daily for 30 days
Outcomes Primary outcomes
  • Number of days alive and out of hospital or emergency department (time frame: in 30 days)


Secondary outcomes
  • Hospitalisation due to bleeding (time frame: in 30 days)

  • Hospitalisations for cardiopulmonary causes (time frame: in 30 days)

  • All‐cause hospitalisation (time frame: in 30 days)

  • All‐cause death (time frame: in 30 days)

  • Days free of VTE (time frame: in 30 days)

  • MACE (time frame: in 30 days)

Starting date 4 March 2021
Contact information renato.lopes@duke.edu
Notes