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

NCT04860518 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: FP1CLI017
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 1. \- Not hospitalized, no limitations on activities 2. \- Not hospitalized, limitation on activities 3. \- Hospitalized, not requiring supplemental oxygen 4. \- Hospitalized, requiring supplemental oxygen 5. \- Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. \- Hospitalized, on invasive mechanical ventilation 7. \- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. \- Death

  Day 14

Secondary Outcomes (2)

• In-hospital Mortality at Day 28 and Day 90

  Day 28 and Day 90

• Overall (All-cause) Mortality at Day 28 and Day 90

  Day 28 and Day 90

Study Arms (2)

IV IFN beta-1a

EXPERIMENTAL

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

Drug: IFN beta-1a

IV Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

IFN beta-1a DRUG

Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised

IV IFN beta-1a

Dexamethasone DRUG

Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised

IV Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faron Pharmaceuticals Ltd: lead

Study Sites (4)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

peginterferon beta-1a; Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

No formal statistical hypotheses were analysed due the early termination of the study with only 5 dosed subjects.

Results Point of Contact

• Title: Dr Juho Jalkanen
• Organization: Faron

juho.jalkanen@faron.com

+358407071046

Study Officials

• Daniel Talmor, MD MPH,

  Deaconess Medical Center, Spokane, Washington

  PRINCIPAL INVESTIGATOR

• Adit Ginde, MD MPH,

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be performed in a double-blind and randomized manner.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: August 23, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: July 21, 2023
• Results First Posted: October 14, 2022

Record last verified: 2023-07

Locations

US (4)