Sirolimus in COVID-19 Phase 1

Walter K. Kraft

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

SARS-CoV-2 Covid-19

Interventions

Sirolimus 1 MG/MLDRUG

Oral solution

PlaceboDRUG

Oral solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment

SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR

Time frame: Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients

Secondary Outcomes

Change in SARS-CoV-2 viral burden at days 1-6

SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR

Time frame: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients

Rate of treatment emergent adverse events

Safety and tolerability of sirolimus in patients with COVID-19

Time frame: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients

Data from ClinicalTrials.gov

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