High Dose Convalescent Plasma in COVID-19: Results from the Randomized Trial CAPSID

  1. Sixten Körper
  2. Manfred Weiss
  3. Daniel Zickler
  4. Thomas Wiesmann
  5. Kai Zacharowski
  6. Victor M.Corman
  7. Beate Grüner
  8. Lucas Ernst
  9. Peter Spieth
  10. Philipp M. Lepper
  11. Martin Bentz
  12. Sebastian Zinn
  13. Gregor Paul
  14. Johannes Kalbhenn
  15. Matthias Dollinger
  16. Peter Rosenberger
  17. Thomas Kirschning
  18. Thomas Thiele
  19. Thomas Appl
  20. Benjamin Mayer
  21. Michael Schmidt
  22. Christian Drosten
  23. Hinnerk Wulf
  24. Jan Matthias Kruse
  25. Bettina Jungwirth
  26. Erhard Seifried
  27. Hubert Schrezenmeier
  28. for the CAPSID Clinical Trial Group
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Abstract

Rationale

COVID-19 convalescent plasma (CCP) has been considered a treatment option in COVID-19.

Objectives

To assess the efficacy of neutralizing antibody containing high-dose CCP in hospitalized adults with COVID-19 requiring respiratory support or intensive care treatment.

Methods

Patients (n=105) were randomized 1:1 to either receive standard treatment and 3 units of CCP or standard treatment alone. Control group patients with progress on day 14 could cross over to the CCP group. Primary outcome was a dichotomous composite outcome of survival and no longer fulfilling criteria for severe COVID-19 on day 21. The trial is registered: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</ext-link> # <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04433910">NCT04433910</ext-link> .

Measurements and main results

The primary outcome occurred in 43.4% of patients in the CCP and 32.7% in the control group (p=0.32). The median time to clinical improvement was 26 days (IQR 15-not reached (n.r.)) in the CCP group and 66 days (IQR 13-n.r.) in the control group (p=0.27). Median time to discharge from hospital was 31 days (IQR 16-n.r.) in the CCP and 51 days (IQR 20–n.r.) in the control group (p=0.24). In the subgroup that received a higher cumulative amount of neutralizing antibodies the primary outcome occurred in 56.0% (versus 32.1%), with a shorter interval to clinical improvement, shorter time to hospital discharge and better survival compared to the control group.

Conclusion

CCP added to standard treatment did not result in a significant difference in the primary and secondary outcomes. A pre-defined subgroup analysis showed a significant benefit for CCP among those who received a larger amount of neutralizing antibodies.

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