Sirolimus in COVID-19 Phase 1

• Status: Withdrawn
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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 defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter K. Kraft
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Male or non-pregnant female >/=18 and
• Laboratory confirmed SARS-CoV-2 infection

• Investigator-estimated hospitalization duration of at least 5 days

Exclusion Criteria:

• 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