Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04382651 | Study of Efficacy and Safety of MAS825 in Patients With COVID-19 | PHASE2 | COMPLETED | 140 | — | — | Jun 11, 2020 | Apr 21, 2021 | Aug 10, 2022 | 21 | United States |
The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points. APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment.
| Arm | Type | Description |
|---|---|---|
| MAS825 + SoC | EXPERIMENTAL | Single dose of MAS825 10 mg/kg by intravenous infusion in addition to SoC |
| Placebo + SoC | PLACEBO_COMPARATOR | Single dose of matching Placebo by intravenous infusion in addition to SoC |
| Name | Type | Description |
|---|---|---|
| MAS825 | DRUG | MAS825 liquid solution for intravenous infusion |
| Placebo | OTHER | Placebo liquid solution for intravenous infusion |
| Standard of Care (SoC) | DRUG | SoC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents. |
Inclusion Criteria: 1. Male and female patients aged ≥18 years at screening 2. Signed Informed Consent Form (ICF) by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative (if allowed according to local requirements) 3...