Outcomes and clinical characteristics of the compassionate use of plitidepsin for immunocompromised adult patients with COVID-19

Int J Infect Dis. 2023 Oct:135:12-17. doi: 10.1016/j.ijid.2023.07.011. Epub 2023 Jul 21.

Abstract

Objectives: To evaluate the compassionate use of plitidepsin as an antiviral treatment in hospitalized immunocompromised adult patients with moderate-to-severe COVID-19.

Design: Retrospective observational study of data -collected from January 01, 2021 to April 30, 2022- from 35 immunocompromised adult patients with COVID-19 non-eligible for other available antiviral treatments. Main outcome measures were time to respiratory recovery (SpFi ≥ 315); COVID-19-related 30-day-cumulative mortality after first plitidepsin infusion; and time to undetectable levels of viral RNA.

Results: Thirty-three patients receiving a full course of plitidepsin (2.5 mg [n = 29] or 1.5 mg [n = 4]) were included. Most (69.7%) had a malignant hematologic disease and 27.3% had solid tumors. A total of 111 infusions were administered with lack of relevant safety events. Median time from plitidepsin initiation to SpFi ≥315 was 8 days (95% confidence interval [CI], 7-19). Median time to first negative reverse transcription-polymerase chain reaction for SARS-CoV-2 (cycle threshold >36) was 17 days (95% CI 13-25). Mortality rate was 16.3% (95% CI 3-37.3).

Conclusion: These data support plitidepsin as a well-tolerated treatment that might have potential clinical and antiviral efficacy in COVID-19 immunocompromised patients.

Keywords: COVID-19; Immunocompromised patients; Persistent viral SARS-CoV-2 replication; Plitidepsin; SARS-CoV-2.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use
  • COVID-19*
  • Compassionate Use Trials
  • Humans
  • Neoplasms* / drug therapy
  • SARS-CoV-2

Substances

  • plitidepsin
  • Antiviral Agents