Prophylactic vs Therapeutic Anticoagulation in Hospitalized Patients With COVID-19: A Randomized Clinical - Summary - MDSpire
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Comparative Analysis of Prophylactic and Therapeutic Anticoagulation in Hospitalized COVID-19 Patients: A Randomized Clinical Trial

  • By

  • Mahir Karakas

  • Shiva Sophia Nicolay

  • Dominic Wichmann

  • Stefan Schmiedel

  • Marylyn M. Addo

  • Anna Nosko

  • Natalie Lund

  • Apurva Shrivastava

  • Isabell Pink

  • Daniel Duerschmied

  • Nadine Gauchel

  • Elisabeth Schnoy

  • Ulrich-Frank Pape

  • Berthold Bein

  • Philipp Brasch

  • Dirk Arnold

  • Katrin Maevers

  • Sebastian Rasch

  • Johanna Erber

  • Tobias Lahmer

  • Tanja Zeller

  • Florian Langer

  • Ann-Kathrin Ozga

  • Anna Suling

  • Antonia Zapf

  • Dominik Jarczak

  • Stefan Kluge

  • September 23, 2026

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Objective:

To compare therapeutic-dose with prophylactic-dose anticoagulation in hospitalized patients with COVID-19.

Approach:
  • Intervention: Participants were randomly assigned in a 1:1 ratio to therapeutic anticoagulation (full-dose low-molecular-weight heparin [LMWH] or fondaparinux during hospitalization, followed by edoxaban) or standard prophylactic anticoagulation (prophylactic-dose LMWH or fondaparinux during hospitalization, followed by placebo).
Key Findings:
  • The final analysis included 139 patients; one patient was excluded because of pre-existing atrial fibrillation.
  • Through 42 days, the primary composite outcome of all-cause mortality or thromboembolic events occurred in 4 of 72 patients (5.6%) assigned to therapeutic anticoagulation and 4 of 67 (6.0%) assigned to prophylactic anticoagulation. The difference was not statistically significant.
  • Major bleeding occurred in 4 patients (5.6%) in the therapeutic group and none in the prophylactic group.
Interpretation:

The study used clinical follow-up and systematic assessment of thromboembolic events. It did not establish that therapeutic anticoagulation improved outcomes compared with prophylactic anticoagulation, and major bleeding was observed only in the therapeutic group.

Limitations:
  • Recruitment challenges resulted in a smaller sample than initially planned, limiting the conclusions that can be drawn.
  • Patients with pre-existing indications for therapeutic anticoagulation were not included.
Conclusion:

Therapeutic-dose anticoagulation did not significantly reduce the primary composite outcome compared with prophylactic-dose anticoagulation in hospitalized patients with COVID-19. Given the small sample and the observed major bleeding in the therapeutic group, the findings do not support a definitive conclusion about the comparative benefits and risks of the two strategies.

Sources:

Original Source(s)

Prophylactic vs Therapeutic Anticoagulation in Hospitalized Patients With COVID-19: A Randomized Clinical

  • by Mahir Karakas, Shiva Sophia Nicolay, Dominic Wichmann, Stefan Schmiedel, Marylyn M. Addo, Anna Nosko, Natalie Lund, Apurva Shrivastava, Isabell Pink, Daniel Duerschmied, Nadine Gauchel, Elisabeth Schnoy, Ulrich-Frank Pape, Berthold Bein, Philipp Brasch, Dirk Arnold, Katrin Maevers, Sebastian Rasch, Johanna Erber, Tobias Lahmer, Tanja Zeller, Florian Langer, Ann-Kathrin Ozga, Anna Suling, Antonia Zapf, Dominik Jarczak, Stefan Kluge

  • September 23, 2026

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