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

COVID 19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04540926
• Other study ID #: 135.2020
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Contact: JOSE LUIS J GALVEZ-ROMERO, MD
• Phone: +522222453511
• Email: jose.galvez[@]issste.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Influenza infection.

Related Conditions & MeSH terms

• COVID 19 Pneumonia
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Mexico	Jose Luis Jl Galvez-Romero	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Country where clinical trial is conducted

Mexico, 

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days to clinical improvement until hospital discharge or death.	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.