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

• DOI: 10.20944/preprints202407.2075.v1
• Publication Date: 2024-07-30T11:00:41Z
• Authors: Lucía Llanos Jiménez; Beatriz Alvarez-A...; Eva Fonseca Aizpuru; Germán Peces-Barba; Gloria Pindao Que...; Maria Jesus Rodri...; Francisco J Ruíz-...; Luis Seijo Maceiras; Ignacio Robles Ba...; Álvaro Mena-de-Cea; Héctor Meijide-Mí...; Olga Sánchez-Pern...
• Keywords: Clinical endpoint; Intention-to-treat analysis

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 efficacy cyclosporin A (CsA) as add-on therapy standard care in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial admitted 8 Spanish Tertiary Hospitals. Patients were stratified into two severity categories and 1:1 receive high dose corticosteroid-based or without CsA. primary endpoint FiO2 recovery by day 12 relapses. Results: 109 included 98 randomized: 51 them assigned CsA+SoC group 47 Standard Care (SoC). 96/98 Intention Treat population. 35 (68.6%) from 32 (71,1%) SoC reached ITT analysis. No differences found after stratification age groups, level at admission combination both. Overall, time normalization 7.4 days vs 7.9 experimental control respectively. Global mortality 8.2%. Severe adverse events uncommon equally distributed between arms. Conclusion: Addition CsA did not show over high-dose corticosteroids-based treatment course patients. better identification candidates who will benefit receiving drugs is necessary future studies.