Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia(COVID-19)

• Research type

  Research Study

• Full title

  Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalised with Severe SARS-CoV-2 Positive Pneumonia

• IRAS ID

  286038

• Contact name

  Vincent-Smith Lisa

• Contact email

  lisa.vincent-smith@nhs.net

• Sponsor organisation

  RedHill Biopharma Ltd.

• Eudract number

  2020-002677-95

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  Opaganib is an investigational product with anti- viral properties targeting RNA viruses, such as coronaviruses, by inhibiting viral replication, combined with anti-inflammatory effects. Opaganib has been studied in pre-clinical models of RNA viral disease, inflammation and cancer.
  This is a phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study The study is planned to be undertaken in approximately 80 clinical sites.
  After informed consent is obtained, patients will enter a screening phase for no
  more than 3 days, to determine eligibility. Approximately 464 eligible patients will
  be randomized and receive either opaganib added to standard of care, or matching placebo added to standard of care, in a randomization ratio of 1:1. Treatment assignments will remain blinded to the patient, investigator and hospital staff, as well as the sponsor.

  Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care at any given institution. The Study drug will be given every day for 14 days (Day 1 to Day 14). All participants will be followed up for 28 days after their last dose of study drug, which may occur at Day 14 or after premature study drug discontinuation, based upon patient or physician determination. The primary objective is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14.
  The population to be enrolled in this study will have severe COVID-19 infection, be hospitalized and require supplemental oxygen to treat hypoxemia, with or without an increased work of breathing.
  Recruitment period is estimated at 4 months. The maximum duration of study participation will be up to 45 days.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  21/SC/0068

• Date of REC Opinion

  18 Feb 2021

• REC opinion

  Favourable Opinion