Cyclosporine A Plus Low-steroid Treatment in COVID-19 Pneumonia

Phase 1

• Conditions: COVID 19 Pneumonia
• Interventions: Drug: Cyclosporin A

• Registration Number: NCT04540926
• Lead Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Brief Summary

Methods: Single-center pilot study included PCR+ SARS-CoV2-patients, hospitalized from April to May 2020 in Puebla, Mexico. Comparative treatment with steroids plus CsA or steroids. Mild, moderate or severe pneumonia was measured by clinical, laboratory tests, lung damage score by computed tomography, and score for clinical improvement. Death rate was evaluated at 28 days.

Detailed Description

This is a pilot study done in a single center (ISSSTE Regional Hospital, Puebla, Mexico). Consecutive patients with suspected or confirmed diagnosis of COVID-19 were assigned, in an unblinded and non-randomized fashion, to receive either steroids plus CsA (intervention group) or steroids only (standard of treatment in this hospital, control group), as per individual clinical judgment. The primary outcome was the number of days to clinical improvement until hospital discharge or death. The secondary outcome was the improvement of patients, defined by the following parameters: lower oxygen requirements (2 liters per minute, or less), absence of fever by three consecutive days, respiratory rate \<22, a decrease of 50% or more in the C reactive protein on admission, and length of hospital stay.

Adult patients attending to the hospital between April 15, to May 31, 2020, fulfilling symptoms compatible with COVID-19 pneumonia, according to the WHO guidance, were invited to participate and all the patients gave their written informed consent.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Primary Completion: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Confirmed COVID 19 pneumonia by clinical, lung computed Tomography and RT-PCR nasopharyngeal swabs.

Exclusion Criteria

• Influenza infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
COVID-19 Pneumonia control group	Cyclosporin A	COVID-19 pneumonia patients with standar treatment: enoxaparin 0.5 mg/kg S.C. once, Clarithromycin 500 mg twice an metylprednisolone 0.5 mg/kg once endovenous.

Primary Outcome Measures

Name	Time	Method
Number of days to clinical improvement until hospital discharge or death.	28 days.	Improvement of patients, defined by the following parameters: lower oxygen requirements (2 liters per minute, or less), absence of fever by three consecutive days, respiratory rate \<22, a decrease of 50% or more in the C reactive protein on admission, and length of hospital stay.

Trial Locations

Locations (1)

Jose Luis Jl Galvez-Romero; 🇲🇽 Puebla, Mexico