Covid-19, SARS-CoV-2
Conditions
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.
Interventions
DRUGSirolimus 1 MG/ML
Oral solution
DRUGPlacebo
Oral solution
Sponsors
Walter K. Kraft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed