Trial Outcomes & Findings for Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19 (NCT NCT04860518)
NCT ID: NCT04860518
Last Updated: 2023-07-21
Results Overview
WHO 9-point ordinal scale: 0 - No detectable infection 1. \- Not hospitalized, no limitations on activities 2. \- Not hospitalized, limitation on activities 3. \- Hospitalized, not requiring supplemental oxygen 4. \- Hospitalized, requiring supplemental oxygen 5. \- Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. \- Hospitalized, on invasive mechanical ventilation 7. \- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. \- Death
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Day 14
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
IV IFN Beta-1a
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
IV IFN Beta-1a
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Overall Study
Screen Failure, patient was not dosed
|
1
|
1
|
Baseline Characteristics
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Baseline characteristics by cohort
| Measure |
IV IFN Beta-1a
n=3 Participants
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=4 Participants
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 7.00 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 15.69 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 12.03 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White and Other (not specified)
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
0: Able to carry out all normal activity without restriction
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) status
2: Ambulatory and capable of all self-care but unable to carry out any work activities
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Only 4 patients had analyzable data on D14
WHO 9-point ordinal scale: 0 - No detectable infection 1. \- Not hospitalized, no limitations on activities 2. \- Not hospitalized, limitation on activities 3. \- Hospitalized, not requiring supplemental oxygen 4. \- Hospitalized, requiring supplemental oxygen 5. \- Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. \- Hospitalized, on invasive mechanical ventilation 7. \- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. \- Death
Outcome measures
| Measure |
IV IFN Beta-1a
n=2 Participants
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=2 Participants
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
|
2 units on a scale
Standard Deviation 0
|
2 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 28 and Day 90Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial
Outcome measures
| Measure |
IV IFN Beta-1a
n=2 Participants
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=3 Participants
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
In-hospital Mortality at Day 28 and Day 90
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 90Percentage of participants per study group that die within 28 days or 90 days from starting the study
Outcome measures
| Measure |
IV IFN Beta-1a
n=2 Participants
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=3 Participants
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Overall (All-cause) Mortality at Day 28 and Day 90
|
0 Participants
|
0 Participants
|
Adverse Events
IV IFN Beta-1a
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IV Dexamethasone
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV IFN Beta-1a
n=2 participants at risk
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=3 participants at risk
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/2 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Injury, poisoning and procedural complications
head injury
|
0.00%
0/2 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
Other adverse events
| Measure |
IV IFN Beta-1a
n=2 participants at risk
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
|
IV Dexamethasone
n=3 participants at risk
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Dexamethasone: Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
0.00%
0/3 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
0.00%
0/3 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Metabolism and nutrition disorders
Hypnoatremia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
0.00%
0/3 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/2 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
33.3%
1/3 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Number of events 1 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
0.00%
0/3 • Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60