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SirCO-1: Sirolimus in COVID-19 Phase 1

Sponsor
Walter K. Kraft (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04371640
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
12.8
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sirolimus 1 MG/ML
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sirolimus

Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg

Drug: Sirolimus 1 MG/ML
Oral solution
Other Names:
  • Rapamune

    		•
    Placebo Comparator: Placebo

    Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL

    Drug: Placebo
    Oral solution

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Walter K. Kraft

    Investigators

    • Principal Investigator: Walter K Kraft, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walter K. Kraft, Principal Investigator, Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT04371640
    Other Study ID Numbers:
    • 15680
    First Posted:
    May 1, 2020
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    COVID-19
    Sirolimus

    Study Results

    No Results Posted as of Dec 3, 2021