Covid19 Clinical Trial
— HIBISCUSOfficial title:
A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection
Verified date | July 2023 |
Source | Faron Pharmaceuticals Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | April 4, 2022 |
Est. primary completion date | April 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Vanderbilt University School of Medicine | Nashville | Tennessee |
United States | Newton-Wellesley Hospital | Newton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Faron Pharmaceuticals Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 - Not hospitalized, no limitations on activities - Not hospitalized, limitation on activities - Hospitalized, not requiring supplemental oxygen - Hospitalized, requiring supplemental oxygen - Hospitalized, on non-invasive ventilation or high flow oxygen devices - Hospitalized, on invasive mechanical ventilation - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) - Death |
Day 14 | |
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 | Day 28 and Day 90 | |
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 | Day 28 and Day 90 |
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