Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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. 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 or baricitinib 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study will be performed in a double-blind and randomized manner.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Vanderbilt University School of Medicine
Nashville, Tennessee 37232
Contact:
Todd W Rice, MD, MSc

More Details

Status
Recruiting
Sponsor
Faron Pharmaceuticals Ltd

Study Contact

Jarna Hannukainen, PhD
+358 02 469 5151
jarna.hannukainen@faron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.