Covid19
Conditions
Brief summary
This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone. Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.
Interventions
DRUGIFN beta-1a
Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
DRUGDexamethasone
Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
Sponsors
Faron Pharmaceuticals Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study will be performed in a double-blind and randomized manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days 3. Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min) 4. Respiratory symptom onset no more than 7 days prior to hospital arrival 5. Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available
Exclusion criteria
1. Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital 2. Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days 3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients 4. Currently receiving IFN-beta-1a therapy 5. Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing 6. Participation in another concurrent interventional pharmacotherapy trial during the study period 7. Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only) 8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test) 9. Subject is not expected to survive for 24 hours 10. Subject has liver failure (Child-Pugh grade C) 11. Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale | Day 14 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Mortality at Day 28 and Day 90 | Day 28 and Day 90 | Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial |
| Overall (All-cause) Mortality at Day 28 and Day 90 | Day 28 and Day 90 | Percentage of participants per study group that die within 28 days or 90 days from starting the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| 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 | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen Failure, patient was not dosed | 1 | 1 |
Baseline characteristics
| Characteristic | IV Dexamethasone | Total | IV IFN Beta-1a |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 15.69 | 57.6 years STANDARD_DEVIATION 12.03 | 60.0 years STANDARD_DEVIATION 7 |
| Eastern Cooperative Oncology Group (ECOG) status 0: Able to carry out all normal activity without restriction | 3 Participants | 6 Participants | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) status 2: Ambulatory and capable of all self-care but unable to carry out any work activities | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized White | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized White and Other (not specified) | 2 participants | 2 participants | 0 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 2 | 2 / 3 |
| serious Total, serious adverse events | 0 / 2 | 2 / 3 |
Outcome results
Primary
Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
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
Time frame: Day 14
Population: Only 4 patients had analyzable data on D14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV IFN Beta-1a | 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 |
| IV Dexamethasone | 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 |
Secondary
In-hospital Mortality at Day 28 and Day 90
Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial
Time frame: Day 28 and Day 90
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV IFN Beta-1a | In-hospital Mortality at Day 28 and Day 90 | 0 Participants |
| IV Dexamethasone | In-hospital Mortality at Day 28 and Day 90 | 0 Participants |
Secondary
Overall (All-cause) Mortality at Day 28 and Day 90
Percentage of participants per study group that die within 28 days or 90 days from starting the study
Time frame: Day 28 and Day 90
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV IFN Beta-1a | Overall (All-cause) Mortality at Day 28 and Day 90 | 0 Participants |
| IV Dexamethasone | Overall (All-cause) Mortality at Day 28 and Day 90 | 0 Participants |