Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

Covid19 Clinical Trial

— HIBISCUS  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04860518
• Other study ID #: FP1CLI017
• Status: Terminated
• Phase: Phase 2
• Start date: August 23, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: July 2023
• Source: Faron Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• IFN beta-1a
Treated daily with IFN beta-1a 10 µg as an IV bolus for 6 days while hospitalised
• Dexamethasone
Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Faron Pharmaceuticals Ltd

Country where clinical trial is conducted

United States, 

Outcome

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