Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sirolimus in COVID-19 Phase 1 (SirCO-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371640
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Walter K. Kraft, Thomas Jefferson University

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
SARS-CoV-2 Covid-19 Drug: Sirolimus 1 MG/ML Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

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 Name: Rapamune

Placebo Comparator: Placebo
Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL
Drug: Placebo
Oral solution




Primary Outcome Measures :
  1. Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients ]
    Safety and tolerability of sirolimus in patients with COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371640


Contacts
Layout table for location contacts
Contact: Edwin Lam, PharmD (215) 955-9076 edwin.lam@jefferson.edu

Locations
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Angela C Pallotto, RN, BSN         
Principal Investigator: Walter K Kraft, MD         
Sub-Investigator: Edwin Lam, PharmD         
Sponsors and Collaborators
Walter K. Kraft
Investigators
Layout table for investigator information
Principal Investigator: Walter K Kraft, MD Thomas Jefferson University
Layout table for additonal information
Responsible Party: Walter K. Kraft, Principal Investigator, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04371640    
Other Study ID Numbers: 15680
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs