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

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: IFN beta-1a; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV IFN beta-1a; Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.	Drug: IFN beta-1a; Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
Active Comparator: IV Dexamethasone; Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.	Drug: Dexamethasone; Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Faron Pharmaceuticals Ltd
• Investigators: Principal Investigator: Daniel Talmor, MD MPH,, Deaconess Medical Center, Spokane, Washington; Principal Investigator: Adit Ginde, MD MPH,, University of Colorado School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: FP1CLI017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No