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

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sirolimus

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loyola University Medical Center
University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sirolimus

Placebo

Arm Description

Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.

Matching placebo

Outcomes

Primary Outcome Measures

Proportion of patients who are alive and free from advanced respiratory support measures at day 28.

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

Proportion of patients who require escalation in care

Progression to a higher level of care, e.g. ICU

Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

Proportion of patients surviving to hospital discharge

Survival to hospital discharge

Drug safety profile

Incidence and type of adverse events

Duration of advanced respiratory support

Number of days spent on advanced respiratory support measures

Duration of hospital stay

Length of hospitalization (in patients who survive to discharge)

Time from treatment initiation to death

Number of days between study initiation and death (in the subset of patients who die during the hospitalization)

Time to resolution of fever

Time (in days) to resolution of fever

Proportion of patients who require initiation of off-label therapies

Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians

Full Information

NCT ID

NCT04341675

First Posted

April 5, 2020

Last Updated

May 18, 2020

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT04341675

Brief Title

Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

Acronym

SCOPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 24, 2020 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randmized, double blind, placebo controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sirolimus

Arm Type

Active Comparator

Arm Description

Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

Rapamycin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

placebo capsules

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Proportion of patients who are alive and free from advanced respiratory support measures at day 28.

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Proportion of patients who require escalation in care

Description

Progression to a higher level of care, e.g. ICU

Time Frame

14 days

Title

Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

Description

Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

Time Frame

14 days

Title

Proportion of patients surviving to hospital discharge

Description

Survival to hospital discharge

Time Frame

days

Title

Drug safety profile

Description

Incidence and type of adverse events

Time Frame

14 days

Title

Duration of advanced respiratory support

Description

Number of days spent on advanced respiratory support measures

Time Frame

days

Title

Duration of hospital stay

Description

Length of hospitalization (in patients who survive to discharge)

Time Frame

days

Title

Time from treatment initiation to death

Description

Number of days between study initiation and death (in the subset of patients who die during the hospitalization)

Time Frame

days

Title

Time to resolution of fever

Description

Time (in days) to resolution of fever

Time Frame

14 days

Title

Proportion of patients who require initiation of off-label therapies

Description

Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nishant Gupta, MD

Phone

5135584831

guptans@ucmail.uc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nishant Gupta, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Davis Alexandria

Phone

513-558-2187

davis5ax@ucmail.uc.edu

First Name & Middle Initial & Last Name & Degree

Nishant Gupta, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

De-identified aggregate data will be made available to other researchers on a case-by-case basis.

Learn more about this trial

Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia

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