NCT04860518.

Study name	Human intravenous interferon beta‐Ia safety and preliminary efficacy in hospitalised subjects with Coronavirus (HIBISCUS)
Methods	Trial design: double‐blind, randomised controlled trial Sample size: 140 Setting: inpatient Language: English Number of centres: 4 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria: 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 Exclusion criteria: Unable to screen, randomise, 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
Interventions	Details of intervention: interferon beta‐Ia Dose: 10 μg for 6 days while hospitalised Route of administration: IV Treatment details of control group (e.g. dose, route of administration): dexamethasone, IV, daily for 6 days while hospitalised, dose not stated Concomitant therapy: n.i.
Outcomes	Primary study outcome: 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 Not hospitalised, no limitations on activities Not hospitalised, limitation on activities Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, on non‐invasive ventilation or high flow oxygen devices Hospitalised, on invasive mechanical ventilation Hospitalised, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) Death
Starting date	23 August 2021
Contact information	Jarna Hannukainen, PhD: +358 02 469 5151 Email: jarna.hannukainen@faron.com Gerd Tötterman: +358 02 469 5151 Email: gerd.totterman@faron.com
Notes	Recruitment status: recruiting Prospective completion date: April 2023 Date last update was posted: 3 January 2022 Sponsor/funding: Faron Pharmaceuticals Ltd