Sirolimus in COVID-19 Phase 1 (SirCO-1)

Walter K. Kraft

Status and phase

Withdrawn

Phase 1

Conditions

Covid-19

SARS-CoV-2

Treatments

Drug: Placebo

Drug: Sirolimus 1 MG/ML

Study type

Interventional

Funder types

Other

Identifiers

NCT04371640

15680

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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