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

• Sponsor: Faron Pharmaceuticals Ltd (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04860518
• Collaborator: (none)
• Enrollment: 7
• Locations: 4
• Arms: 2
• Actual Duration (Months): 7.4
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: IFN beta-1a; Drug: Dexamethasone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The study will be performed in a double-blind and randomized manner.
• Primary Purpose: Other
• 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
• Actual Study Start Date: Aug 23, 2021
• Actual Primary Completion Date: Apr 4, 2022
• Actual Study Completion Date: Apr 4, 2022

Arms and Interventions

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 as an IV bolus for 6 days while hospitalised

Outcome Measures

Primary Outcome Measures

1. 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 - 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

1. Clinical status at Day 28 [Day 28]

   As measured by WHO 9-point ordinal scale

2. In-hospital mortality at Day 28 and Day 90 [Day 28 and Day 90]

3. Overall (all-cause) mortality at Day 28 and Day 90 [Day 28 and Day 90]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Newton-Wellesley Hospital	Newton	Massachusetts	United States	02462
4	Vanderbilt University School of Medicine	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Faron Pharmaceuticals Ltd
• ClinicalTrials.gov Identifier: NCT04860518
• Other Study ID Numbers: FP1CLI017
• First Posted: Apr 27, 2021
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Dexamethasone

Study Results

No Results Posted as of May 16, 2022