Sirolimus in COVID-19 Phase 1
- Registration Number
- NCT04371640
- Lead Sponsor
- Walter K. Kraft
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sirolimus Sirolimus 1 MG/ML Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg Placebo Placebo Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL
- Primary Outcome Measures
Name Time Method Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR
- Secondary Outcome Measures
Name Time Method Rate of treatment emergent adverse events Days 1, 2, 3, 4, 5, and 6 post-dose for all patients Safety and tolerability of sirolimus in patients with COVID-19
Change in SARS-CoV-2 viral burden at days 1-6 Days 1, 2, 3, 4, 5, and 6 post-dose for all patients SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital🇺🇸Philadelphia, Pennsylvania, United States