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.
Drug: Sirolimus 1 MG/ML
Oral solution
Other Name: Rapamune
Drug: Placebo
Oral solution
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
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Walter K Kraft, MD, Principal Investigator
Thomas Jefferson University