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Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (SCOPE)

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: NCT04341675
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Nishant Gupta, MD, MS, University of Cincinnati

Brief Summary:
The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 30 subjects will be randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Sirolimus Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randmized, double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Sirolimus

Arm Intervention/treatment
Active Comparator: Sirolimus
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
Drug: Sirolimus
Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.
Other Name: Rapamycin

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo
Other Name: placebo capsules




Primary Outcome Measures :
  1. Proportion of patients who are alive and free from advanced respiratory support measures at day 28. [ Time Frame: 28 days ]

    Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group.

    * CPAP use for known obstructive sleep apnea will not be considered as disease progression.



Secondary Outcome Measures :
  1. Proportion of patients who require escalation in care [ Time Frame: 14 days ]
    Progression to a higher level of care, e.g. ICU

  2. Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count) [ Time Frame: 14 days ]
    Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

  3. Proportion of patients surviving to hospital discharge [ Time Frame: days ]
    Survival to hospital discharge

  4. Drug safety profile [ Time Frame: 14 days ]
    Incidence and type of adverse events

  5. Duration of advanced respiratory support [ Time Frame: days ]
    Number of days spent on advanced respiratory support measures

  6. Duration of hospital stay [ Time Frame: days ]
    Length of hospitalization (in patients who survive to discharge)

  7. Time from treatment initiation to death [ Time Frame: days ]
    Number of days between study initiation and death (in the subset of patients who die during the hospitalization)

  8. Time to resolution of fever [ Time Frame: 14 days ]
    Time (in days) to resolution of fever

  9. Proportion of patients who require initiation of off-label therapies [ Time Frame: 14 days ]
    Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects enrolled in the trial must meet all of the following criteria.

  • Confirmed COVID-19 pneumonia
  • Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
  • Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count <1,000/uL
  • Age ≥ 18 years
  • Completed informed consent

Exclusion Criteria:

Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:

  • Known allergy or hypersensitivity to sirolimus
  • Inability or refusal to provide informed consent
  • Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
  • Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
  • Pregnant women
  • Breast feeding
  • On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
  • Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):

    • History of liver cirrhosis
    • End stage renal disease or need for renal replacement therapy
    • Decompensated heart failure
    • Known active tuberculosis or history of incompletely treated tuberculosis
    • Uncontrolled systemic bacterial or fungal infections
    • Active viral infection other than COVID-19

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): NCT04341675


Contacts
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Contact: Nishant Gupta, MD 5135584831 guptans@ucmail.uc.edu

Locations
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United States, Illinois
Loyola University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60153
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Davis Alexandria    513-558-2187    davis5ax@ucmail.uc.edu   
Principal Investigator: Nishant Gupta, MD         
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Nishant Gupta, MD University of Cincinnati
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Responsible Party: Nishant Gupta, MD, MS, Adjunct Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04341675    
Other Study ID Numbers: 2020-0337
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified aggregate data will be made available to other researchers on a case-by-case basis.

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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:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs