At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
Cyclosporine +1 moredrug
Likely dose
Cyclosporine 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase IIa Clinical Trial Of Cyclosporine For The Treatment Of COVID-19(+) Non-ICU Hospital Inpatients
In Brief
A Phase 2 clinical trial evaluating Cyclosporine and Standard of Care Treatment for SARS (Disease). Completed, enrolled 47 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS (Disease)
CountriesUnited States
CollaboratorsBrigham and Women's Hospital
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartNov 2020
Primary CompletionDec 2021
TodayJul 2026
First PostedJul 30, 2020
Enrollment StartNov 23, 2020
Primary CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.9 years ago
Interventions
Cyclosporinedrug
2.5 mg/kg PO BID 7 days
Standard of Care Treatmentother
Standard of Care Treatment, N= 25 Patients, 7 days