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

September 4, 2020 updated by: JOSE LUIS GALVEZ-ROMERO, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Puebla, Mexico, 72570
        • Jose Luis Jl Galvez-Romero
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Influenza infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days to clinical improvement until hospital discharge or death.
Time Frame: 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.
28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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