Official Title
A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)
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 defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.

Recruiting
SARS-CoV-2
COVID-19

Drug: Sirolimus 1 MG/ML
Oral solution
Sirolimus
Other Name: Rapamune

Drug: Placebo
Oral solution
Placebo

Eligibility Criteria

Inclusion Criteria:

- Male or non-pregnant female >/=18 and 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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 65 Years
Countries
United States
Locations

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Recruiting

Investigator: Angela C Pallotto, RN, BSN

Investigator: Walter K Kraft, MD

Investigator: Edwin Lam, PharmD

Contacts

Edwin Lam, PharmD
(215) 955-9076
edwin.lam@jefferson.edu

Walter K Kraft, MD
Principal Investigator
Thomas Jefferson University

Walter K. Kraft
NCT Number
MeSH Terms
Sirolimus