Sirolimus in COVID-19 Phase 1 (SirCO-1)
Primary Purpose
SARS-CoV-2, Covid-19
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sirolimus 1 MG/ML
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sirolimus
Placebo
Arm Description
Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg
Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Rate of treatment emergent adverse events
Safety and tolerability of sirolimus in patients with COVID-19
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04371640
Brief Title
Sirolimus in COVID-19 Phase 1
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study population not regularly admitted to hospital and approaches have shifted away from repurposing old drugs.
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walter K. Kraft
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sirolimus
Arm Type
Active Comparator
Arm Description
Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL
Intervention Type
Drug
Intervention Name(s)
Sirolimus 1 MG/ML
Other Intervention Name(s)
Rapamune
Intervention Description
Oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral solution
Primary Outcome Measure Information:
Title
Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment
Description
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 Outcome Measure Information:
Title
Change in SARS-CoV-2 viral burden at days 1-6
Description
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
Title
Rate of treatment emergent adverse events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter K Kraft, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sirolimus in COVID-19 Phase 1
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