Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gimsilumab · 1 trial · 1 indication
"Incidence" is defined as the percent of subjects that died by Day 43
| Arm | Type | Description |
|---|---|---|
| Gimsilumab | EXPERIMENTAL | Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8 |
| Placebo | PLACEBO_COMPARATOR | Normal saline on Day 1 Normal saline on Day 8 |
| Name | Type | Description |
|---|---|---|
| Gimsilumab | DRUG | Gimsilumab is a fully human monoclonal antibody (mAb). |
| Placebo | DRUG | Normal saline |
Inclusion Criteria: 1. Male or non-pregnant female age ≥18 years, inclusive 2. Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form 3. Has laboratory-conf...
Gimsilumab is an investigational small molecule being studied for the treatment of COVID-19, specifically for lung injury or acute respiratory distress syndrome secondary to COVID-19. It is currently in Phase 2 clinical development and is not approved by the FDA.
Gimsilumab is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ROIV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with COVID-19-related lung complications.
Gimsilumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial for Gimsilumab has been completed, and the drug is no longer in active clinical testing.
Gimsilumab was studied in a Phase 2 clinical trial with the identifier NCT04351243, known as the BREATHE study. This randomized, double-blind, placebo-controlled trial enrolled 227 participants in the United States to assess the drug's efficacy and safety in patients with lung injury or acute respiratory distress syndrome secondary to COVID-19.
Gimsilumab is a distinct investigational drug with no alternative names. It is a small molecule being developed by Roivant Sciences for COVID-19-related respiratory complications. Its mechanism of action has not been publicly disclosed.