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

Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04540926

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Days)

209.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID 19 Pneumonia	Drug: Cyclosporin A	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

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 judgmentConsecutive 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Utility of Low Doses of Corticosteroids and Cyclosporine Combined With Enoxaparin, in Patients With COVID-19 Pneumonia at the ISSSTE Regional Hospital, Puebla, During the Contingency Period Due to the SARS-Cov2 Pandemic

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COVID-19 Pneumonia control group 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.	Drug: Cyclosporin A COVID-19 pneumonia patients treated with oral CsA at a dose of 1-2 mg /kg / day divided into two doses, for 7 days, since entering to hospitalization.

Arm

Intervention/Treatment

Experimental: COVID-19 Pneumonia control group

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.

Drug: Cyclosporin A

COVID-19 pneumonia patients treated with oral CsA at a dose of 1-2 mg /kg / day divided into two doses, for 7 days, since entering to hospitalization.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Influenza infection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jose Luis Jl Galvez-Romero	Puebla		Mexico	72570

Sponsors and Collaborators

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Investigators

Principal Investigator: JOSE LUIS J GALVEZ-ROMERO, MD, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JOSE LUIS GALVEZ-ROMERO, Master in Medical Sciences and Reasearch and Medical Doctor, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

ClinicalTrials.gov Identifier:

NCT04540926

Other Study ID Numbers: