Trial Outcomes & Findings for Etoposide in Patients With COVID-19 Infection (NCT NCT04356690)
NCT ID: NCT04356690
Last Updated: 2023-06-15
Results Overview
8-Point Ordinal Scale of Respiratory Function: 8 -Death; 7 -Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min) 6 -Intubation and mechanical ventilation 5 -Non-invasive mechanical ventilation (NIV) or high-flow oxygen 4 -Hospitalized, requiring oxygen by mask or nasal prongs 3 -Hospitalization without oxygen supplementation 2-Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility(+/-supplemental oxygen); 1 -Discharged to home without supplemental oxygen
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
baseline, through hospital discharge or death
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Etoposide
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Etoposide in Patients With COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
74.5 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Baseline Ferritin Blood Levels
|
1754.17 ng/ml
STANDARD_DEVIATION 797.34 • n=5 Participants
|
2699.5 ng/ml
STANDARD_DEVIATION 3270.37 • n=7 Participants
|
1990.5 ng/ml
STANDARD_DEVIATION 1474.28 • n=5 Participants
|
|
Baseline white blood cell counts
|
12.57 cells x1000 per mL
STANDARD_DEVIATION 7.79 • n=5 Participants
|
16.75 cells x1000 per mL
STANDARD_DEVIATION 4.45 • n=7 Participants
|
13.61 cells x1000 per mL
STANDARD_DEVIATION 7.07 • n=5 Participants
|
|
Baseline C Reactive protein levels
|
151.17 mg/L
STANDARD_DEVIATION 130.15 • n=5 Participants
|
145.50 mg/L
STANDARD_DEVIATION 111.02 • n=7 Participants
|
149.75 mg/L
STANDARD_DEVIATION 117.76 • n=5 Participants
|
|
Baseline d-dimer blood levels
|
1394.00 ng/ml DDU
STANDARD_DEVIATION 1183.31 • n=5 Participants
|
4745.00 ng/ml DDU
STANDARD_DEVIATION 6167.39 • n=7 Participants
|
2231.75 ng/ml DDU
STANDARD_DEVIATION 2973.25 • n=5 Participants
|
|
Baseline platelet counts
|
274.50 cells x 1000 per mL
STANDARD_DEVIATION 193.45 • n=5 Participants
|
274.50 cells x 1000 per mL
STANDARD_DEVIATION 126.57 • n=7 Participants
|
274.50 cells x 1000 per mL
STANDARD_DEVIATION 170.35 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, through hospital discharge or death8-Point Ordinal Scale of Respiratory Function: 8 -Death; 7 -Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min) 6 -Intubation and mechanical ventilation 5 -Non-invasive mechanical ventilation (NIV) or high-flow oxygen 4 -Hospitalized, requiring oxygen by mask or nasal prongs 3 -Hospitalization without oxygen supplementation 2-Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility(+/-supplemental oxygen); 1 -Discharged to home without supplemental oxygen
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Improvement in Pulmonary Status by Two Categories on an 8 Point Ordinal Scale of Respiratory Function
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 DaysNumber of participants that lived to day 30 or hospital discharge
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Overall Survival
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of enrollment until date of dischargeNumber of days participants were hospitalized after treatment
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Length of Hospitalization
|
17 days
Standard Deviation 11.35
|
24 days
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: From date of enrollment until the date of extubationPopulation: 4 participants who were not extubated before death are excluded- 3 in Etoposide arm and 1 in the Control arm.
Number of days participants were ventilated after treatment
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=3 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=1 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Duration of Ventilation After Treatment
|
15.67 days
Standard Deviation 12.9
|
15.0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline, to day 30 (or discharge or death)Change in ferritin from treatment to day 30
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Change in Blood Ferritin Levels
|
1235.67 ng/mL
Standard Deviation 1180.59
|
-1771.50 ng/mL
Standard Deviation 2320.02
|
SECONDARY outcome
Timeframe: baseline, to day 30 (or discharge or death)Change in CRP levels from treatment to day 30
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Change in C-reactive Protein (CRP) Levels
|
-49.00 mg/L
Standard Deviation 64.38
|
-74.00 mg/L
Standard Deviation 63.64
|
SECONDARY outcome
Timeframe: baseline, to day 30 (or discharge or death)Change in d-dimer from treatment to day 30
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Change in D-dimer Blood Levels
|
480.67 mg/ml DDU
Standard Deviation 2427.12
|
-2243.00 mg/ml DDU
Standard Deviation 3618.97
|
SECONDARY outcome
Timeframe: baseline, to day 30 (or discharge or death)Change in white blood cell count from treatment to day 30
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Change in White Blood Cell Count
|
5.18 cells x 1000 per mL
Standard Deviation 6.35
|
13.40 cells x 1000 per mL
Standard Deviation 10.04
|
SECONDARY outcome
Timeframe: baseline, to day 30 (or discharge or death)Change in platelet count from treatment to day 30
Outcome measures
| Measure |
Cohort 1 - Etoposide
n=6 Participants
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 Participants
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Change in Platelet Count
|
-70.00 cells x 1000 per mL
Standard Deviation 100.84
|
102.00 cells x 1000 per mL
Standard Deviation 72.12
|
Adverse Events
Cohort 1 - Etoposide
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort 1 - Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1 - Etoposide
n=6 participants at risk
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 participants at risk
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Infections and infestations
febrile neutropenia
|
16.7%
1/6 • Number of events 1 • Treatment/enrollment until discharge or death
|
0.00%
0/2 • Treatment/enrollment until discharge or death
|
Other adverse events
| Measure |
Cohort 1 - Etoposide
n=6 participants at risk
Participants that are on ventilation Etoposide 150 mg/m2 daily days 1 and 4
Etoposide: Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
|
Cohort 1 - Control
n=2 participants at risk
Standard of care therapy in participants that are on ventilation
|
|---|---|---|
|
Blood and lymphatic system disorders
thrombocytopenia
|
33.3%
2/6 • Number of events 2 • Treatment/enrollment until discharge or death
|
0.00%
0/2 • Treatment/enrollment until discharge or death
|
|
Blood and lymphatic system disorders
anemia
|
66.7%
4/6 • Number of events 4 • Treatment/enrollment until discharge or death
|
50.0%
1/2 • Number of events 1 • Treatment/enrollment until discharge or death
|
|
Blood and lymphatic system disorders
neutropenia
|
50.0%
3/6 • Number of events 3 • Treatment/enrollment until discharge or death
|
0.00%
0/2 • Treatment/enrollment until discharge or death
|
|
Hepatobiliary disorders
Abnormal LFTs
|
16.7%
1/6 • Number of events 1 • Treatment/enrollment until discharge or death
|
0.00%
0/2 • Treatment/enrollment until discharge or death
|
|
Renal and urinary disorders
acute kidney innury
|
16.7%
1/6 • Number of events 1 • Treatment/enrollment until discharge or death
|
50.0%
1/2 • Number of events 1 • Treatment/enrollment until discharge or death
|
|
Infections and infestations
ventilatory asscociated pneumonia
|
16.7%
1/6 • Number of events 1 • Treatment/enrollment until discharge or death
|
0.00%
0/2 • Treatment/enrollment until discharge or death
|
Additional Information
John Mark Sloan, MD
Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center
Phone: 617-638-7002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place