This is a Phase 2, randomized, placebo -controlled, participant and investigator blinded, multi-center study to assess efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function.
The study consists of five parts:
- Screening / Baseline / Treatment (Day -1 to 1): lasts up to a maximum of 24 hours and comprises a screening / baseline assessment. This visit will be used to confirm that the study inclusion and exclusion criteria are met and serves as baseline assessment prior to randomization. Baseline blood tests will be performed in all patients; those who screen fail because of study inclusion / exclusion criteria (e.g., serum CRP, liver function tests), will not undergo randomization. Eligible patients will receive a single i.v. infusion of MAS825 or placebo on Day -1 to 1.
- Treatment period (Day 2-15): Study assessments to be conducted every 2 days for hospitalized patients. If patients are discharged from the hospital prior to Day 15, assessments on the day of discharge should be performed according to the schedule listed under Day 15 and patient should return to the site for the Day 15 assessment (all other visits between discharge and Day 15 can be omitted). If hospital visit is not possible at Day 15, then home nursing services may be used to support this last visit where these are available in accordance with local guidelines and should include all possible assessments (e.g. oxygen saturation with portable monitors). In case home nursing is not possible, patients will be contacted by phone on day 15.
- Follow-up (Day 16-29): After completion of the treatment period, patients will be observed until Day 29 or discharged from hospital, whichever is sooner. Study assessments to be conducted every 2 days for domiciled patients. Where patients are discharged from hospital prior to Day 29, a study visit conducted by telephone will occur on Day 29 (all other visits between discharge and Day 29 can be omitted).
- Safety follow-up visit assessment (Day 45): A follow-up visit will be conducted at Day 45 if the patient is hospitalized. If patients are discharged from hospital prior to Day 45, a study visit will be conducted by telephone on Day 45.
- End of Study/Safety follow-up visit assessment (Day 127): A follow-up visit for safety will be conducted at Day 127 if the patient is hospitalized. If patients are discharged from hospital prior to Day 127, a study visit will be conducted by telephone on Day 127.