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This work was supported by a generous donation from Fundacion Tatiana Perez de Guzman el Bueno; https://www.fundaciontatiana.com/). Cyclosporin A was provided by each participating hospital's pharmacy department at no cost.

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Cyclosporin A as an Add-On Therapy to a Corticosteroid-Based Background Treatment in Patients with COVID-19: A Multicenter, Randomized Clinical Trial

Publicated to:Journal of Clinical Medicine. 13 (17): 5242- - 2024-09-01 13(17), DOI: 10.3390/jcm13175242

Authors: Llanos Jimenez, Lucia; Alvarez-Alvarez, Beatriz; Fonseca Aizpuru, Eva; Peces-Barba, German; Quesada, Gloria Pindao; Nieto, Ma Jesus Rodriguez; Ruiz-Hornillos, Francisco J; Maceiras, Luis Seijo; Barrena, Ignacio Robles; Mena-de-Cea, Alvaro; Meijide-Miguez, Hector; Sanchez-Pernaute, Olga

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Abstract

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results: 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion: The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies.

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