Cyclosporine A Plus Low-steroid Treatment in COVID-19 Pneumonia
NCT ID: NCT04540926
Last Updated: 2020-09-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-09-30
Study Completion Date
2020-09-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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COVID 19 Pneumonia
Study Design
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Allocation Method
NA
Intervention Model
SEQUENTIAL
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
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Cyclosporin A
Intervention Type
DRUG
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.
Interventions
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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.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Confirmed COVID 19 pneumonia by clinical, lung computed Tomography and RT-PCR nasopharyngeal swabs.
Exclusion Criteria
* Influenza infection.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
OTHER_GOV
Sponsor Role
lead
Responsible Party
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JOSE LUIS GALVEZ-ROMERO
Master in Medical Sciences and Reasearch and Medical Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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JOSE LUIS J GALVEZ-ROMERO, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Locations
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Jose Luis Jl Galvez-Romero
Puebla City, , Mexico
Site Status
Countries
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Mexico
Central Contacts
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Facility Contacts
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References
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Reference Type
RESULT
Other Identifiers
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135.2020
Identifier Type: -
Identifier Source: org_study_id
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