Clinical trial NCT04860518: Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Faron Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
timeFrame: Day 14
Secondary outcomes:
measure: In-hospital Mortality at Day 28 and Day 90
timeFrame: Day 28 and Day 90
measure: Overall (All-cause) Mortality at Day 28 and Day 90
timeFrame: Day 28 and Day 90
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
Study officials:
affiliation: Deaconess Medical Center, Spokane, Washington
name: Daniel Talmor, MD MPH,
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado School of Medicine
name: Adit Ginde, MD MPH,
role: PRINCIPAL_INVESTIGATOR
References: