Sirolimus in COVID-19 Phase 1

Covid-19 Clinical Trial

— SirCO-1  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04371640
• Other study ID #: 15680
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 6, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• SARS-CoV-2

Intervention

Drug:
• Sirolimus 1 MG/ML
Oral solution
• Placebo
Oral solution

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Walter K. Kraft

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients
Secondary	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	Days 1, 2, 3, 4, 5, and 6 post-dose for all patients
Secondary	Rate of treatment emergent adverse events	Safety and tolerability of sirolimus in patients with COVID-19	Days 1, 2, 3, 4, 5, and 6 post-dose for all patients