Status:
WITHDRAWN
Sirolimus in COVID-19 Phase 1
Lead Sponsor:
Walter K. Kraft
Conditions:
SARS-CoV-2
Covid-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is ...
Eligibility Criteria
Inclusion
- Male or non-pregnant female \>/=18 and \</=65 years of age at the time of consent
- Laboratory confirmed SARS-CoV-2 infection
- Investigator-estimated hospitalization duration of at least 5 days
Exclusion
- Need for \>4 liters nasal cannula oxygen to maintain oxygen saturation \>90%
- Hypersensitivity to sirolimus
- Pregnant or breastfeeding
- Anticipated transfer to another study hospital within 72 hours
- Alanine transaminase (ALT) \>3 times the upper limit of normal
- Creatinine clearance \<30mL/min as estimated by Cockcroft-Gault
- Underlying immunosuppression due to daily \>5 mg prednisone equivalent a day, prior solid organ transplant, or other immunosuppression deemed by investigator to be potentially unsafe
- Co-administration with strong inhibitors of CYP3A4 and/or P-glycoprotein (P-gp) (such as ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin and others)
- Co-administration with strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) (such as phenytoin or rifampin)
- Anticipated surgery within 1 month
- Need for healing of a fracture or a significant soft tissue wound
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04371640
Start Date
July 6 2020
End Date
July 30 2021
Last Update
December 3 2021
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107