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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IFN beta-1a
Dexamethasone
Sponsored by
Faron Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Anschutz Medical Campus
  • Beth Israel Deaconess Medical Center
  • Newton-Wellesley Hospital
  • Vanderbilt University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV IFN beta-1a

IV Dexamethasone

Arm Description

Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.

Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
April 22, 2021
Last Updated
July 3, 2023
Sponsor
Faron Pharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04860518
Brief Title
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faron Pharmaceuticals Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be performed in a double-blind and randomized manner.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV IFN beta-1a
Arm Type
Experimental
Arm Description
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
Arm Title
IV Dexamethasone
Arm Type
Active Comparator
Arm Description
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.
Intervention Type
Drug
Intervention Name(s)
IFN beta-1a
Intervention Description
Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
Primary Outcome Measure Information:
Title
Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
Description
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
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
In-hospital Mortality at Day 28 and Day 90
Description
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
Title
Overall (All-cause) Mortality at Day 28 and Day 90
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min) Respiratory symptom onset no more than 7 days prior to hospital arrival Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available Exclusion Criteria: Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital 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 Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients Currently receiving IFN-beta-1a therapy 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 Participation in another concurrent interventional pharmacotherapy trial during the study period Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only) Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test) Subject is not expected to survive for 24 hours Subject has liver failure (Child-Pugh grade C) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Talmor, MD MPH,
Organizational Affiliation
Deaconess Medical Center, Spokane, Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adit Ginde, MD MPH,
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Vanderbilt University School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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