Cyclosporine A plus low‐dose steroid treatment in COVID‐19 improves clinical outcomes in patients with moderate to severe disease. A pilot study

Galvez‐Romero, Jose Luis; Palmeros‐Rojas, Oscar; Real‐Ramírez, Fernando Antonio; Sánchez‐Romero, Saúl; Tome‐Maxil, Ramiro; Ramírez‐Sandoval, María Patricia; Olivos‐Rodríguez, Rosaura; Flores‐Encarnación, Salvador Eduardo; Cabrera‐Estrada, Ana América; Ávila‐Morales, José; Cortés‐Sánchez, Víctor; Sarmiento‐Padilla, Gonzalo; Tezmol‐Ramírez, Sandra Elizabeth; Aparicio‐Hernández, David; Urbina‐Sánchez, Mario Iván; Gómez‐Pluma, Miguel Ángel; Cisneros‐Méndez, Surizadith; Rodríguez‐Rivas, Dinorah Ivonne; Reyes‐Inurrigarro, Sergio; Cortés‐Díaz, Gilberto; Cruz‐Delgado, Carlos; Navarro‐González, Jaqueline; Deveaux‐Homs, José; Pedraza‐Sánchez, Sigifredo

BACKGROUND: COVID‐19 pandemic causes high global morbidity and mortality, and better medical treatments to reduce mortality are needed. OBJECTIVE: To determine the added benefit of Cyclosporine‐A (CsA), to low‐dose steroid treatment, in patients with COVID‐19. METHODS: Open‐label, non‐randomized pilot study of patients with confirmed infection of SARS‐CoV2, hospitalized from April to May 2020 at a single center in Puebla, Mexico. Comparative treatment with steroids or CsA plus steroids. Pneumonia severity was assessed by clinical, laboratory, and lung tomography. The death rate was evaluated at 28 days. RESULTS: 209 adult patients were studied, 105 received CsA plus steroids (age 55.3 ±13.3; 69% men), and 104 steroids alone (age 54.06 ±13.8; 61% men). All patients received clarithromycin, enoxaparin, and methylprednisolone or prednisone up to 10 days. Patient´s death was associated with hypertension (RR=3.5) and diabetes (RR=2.3). Mortality was 22 and 35% for CsA and control groups (p=0.02), respectively, for all patients, and 24 and 48.5% for patients with moderate to severe disease (p=0.001). Higher cumulative clinical improvement was seen for the CsA group (Nelson Aalen curve, p=0.001, log‐rank test) in moderate to severe patients. The Cox proportional hazard analysis showed the highest HR improvement value of 2.15 (1.39‐3.34, 95%CI, p=0.0005) for CsA treatment in moderate to severe patients, and HR = 1.95 (1.35‐2.83, 95%CI, p=0.0003) for all patients. CONCLUSION: CsA used as an adjuvant to steroid treatment for COVID‐19 patients showed to improve outcomes and reduce mortality, mainly in those with moderate to severe disease. Further investigation through controlled clinical trials is warranted.