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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04382053 | Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia | PHASE2 | COMPLETED | 143 | — | — | May 27, 2020 | Dec 24, 2020 | Jul 26, 2022 | 29 | Argentina, Brazil +10 |
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 |
|---|---|---|
| DFV890 + SoC | EXPERIMENTAL | DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC. |
| Standard of Care (SoC) | ACTIVE_COMPARATOR | SoC was used as an active comparator arm. |
| Name | Type | Description |
|---|---|---|
| DFV890 | DRUG | DFV890 25 mg tablets orally/nasogastrically administered 50 mg b.i.d for 14 days in addition to SoC. |
| 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: * Male and female patients aged 18-80 years inclusive at screening. * Clinically diagnosed with the SARS-CoV-2 virus by polymerase chain reaction (PCR) or by other approved diagnostic methodology within 7 days prior to randomization. * Hospitalized with COVID-19-induced pneumoni...