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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: IFN beta-1a; Drug: Dexamethasone

• Registration Number: NCT04860518
• Lead Sponsor: Faron Pharmaceuticals Ltd

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Study Start: 2021-08-23
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Results First Submitted: 2022-09-12
• Results First Submitted QC: 2022-10-12
• Results First Posted: 2022-10-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV IFN beta-1a	IFN beta-1a	Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline.
IV Dexamethasone	Dexamethasone	Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone.

Primary Outcome Measures

Name	Time	Method
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; 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

Secondary Outcome Measures

Name	Time	Method
Overall (All-cause) Mortality at Day 28 and Day 90	Day 28 and Day 90	Percentage of participants per study group that die within 28 days or 90 days from starting the study
In-hospital Mortality at Day 28 and Day 90	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

Trial Locations

Locations (4)

Newton-Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Vanderbilt University School of Medicine; 🇺🇸 Nashville, Tennessee, United States