Trial Outcomes & Findings for Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (NCT NCT04341675)
NCT ID: NCT04341675
Last Updated: 2024-04-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
28 days
Results posted on
2024-04-05
Participant Flow
Participant milestones
| Measure |
Sirolimus
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
Baseline characteristics by cohort
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 15 • n=5 Participants
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
57 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysDeath 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.
Outcome measures
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 28 daysSurvival to hospital discharge
Outcome measures
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Percentage of Patients Surviving to Hospital Discharge
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of patients with adverse events
Outcome measures
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Drug Safety Profile
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: daysLength of hospitalization is measured as the number of days in the hospital from the date of randomization until the date of discharge or death from any cause, whichever came first, assessed up to 28 days post discharge.
Outcome measures
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Duration of Hospital Stay
|
9.9 days
Standard Deviation 12.2
|
12.9 days
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 28 daysPatients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians
Outcome measures
| Measure |
Sirolimus
n=18 Participants
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Number of Patients Who Require Initiation of Off-label Therapies
|
0 Participants
|
0 Participants
|
Adverse Events
Sirolimus
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sirolimus
n=18 participants at risk
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 participants at risk
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
5.6%
1/18 • Number of events 1 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Need for advanced respiratory support
|
11.1%
2/18 • Number of events 2 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
Sirolimus
n=18 participants at risk
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
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.
|
Placebo
n=10 participants at risk
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
3/18 • Number of events 3 • 28 days
|
0.00%
0/10 • 28 days
|
|
Blood and lymphatic system disorders
Thromboembolism
|
0.00%
0/18 • 28 days
|
30.0%
3/10 • Number of events 3 • 28 days
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/18 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
|
Hepatobiliary disorders
Elevated liver function tests
|
5.6%
1/18 • Number of events 1 • 28 days
|
10.0%
1/10 • Number of events 1 • 28 days
|
|
Infections and infestations
Bacterial infection
|
11.1%
2/18 • Number of events 2 • 28 days
|
0.00%
0/10 • 28 days
|
|
Cardiac disorders
Fluid overload
|
5.6%
1/18 • Number of events 1 • 28 days
|
0.00%
0/10 • 28 days
|
|
Investigations
Abnormal serum electrolytes
|
5.6%
1/18 • Number of events 1 • 28 days
|
0.00%
0/10 • 28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • 28 days
|
0.00%
0/10 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place