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

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ClinicalTrials.gov Identifier: NCT04540926
Recruitment Status : Not yet recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
JOSE LUIS GALVEZ-ROMERO, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Influenza infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540926


Contacts
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Contact: JOSE LUIS J GALVEZ-ROMERO, MD +522222453511 ext 1100 jose.galvez@issste.gob.mx

Locations
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Mexico
Jose Luis Jl Galvez-Romero
Puebla, Mexico, 72570
Contact: JOSE LUIS J GALVEZ-ROMERO    +522222453511 ext 1100    jose.galvez@issste.gob.mx   
Sponsors and Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Investigators
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Principal Investigator: JOSE LUIS J GALVEZ-ROMERO, MD Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Publications of Results:

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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: 135.2020
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors