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Cyclosporine For The Treatment Of COVID-19(+)

NCT04492891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-07-20

Study results available
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Summary

Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of an oral formulation of cyclosporine, Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no Neoral + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.

Conditions

  • SARS (Disease)

Interventions

DRUG

Cyclosporine

2.5 mg/kg PO BID 7 days

OTHER

Standard of Care Treatment

Standard of Care Treatment, N= 25 Patients, 7 days

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Bryan Burt, MD

    lead OTHER

Principal Investigators

  • Bryan Burt, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2021-12-10
Completion
2021-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492891 on ClinicalTrials.gov