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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04920916 | Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients | PHASE2 | COMPLETED | 40 | — | — | May 25, 2021 | Apr 18, 2023 | Nov 3, 2023 | 1 | United States |
Proportion of patients alive and free of invasive mechanical ventilation
Proportion of patients with abnormal diffusing capacity for carbon monoxide (DLCO) and/or 6 minute walk testing 1 year after acute COVID-19 infection.
| Arm | Type | Description |
|---|---|---|
| Dupilimab | EXPERIMENTAL | Dupilimab: 600 mg, given as two 300 mg subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28. |
| Placebo | PLACEBO_COMPARATOR | Normal saline will be given as two one mL subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (1 mL) will be given on days 14 and 28. |
| Name | Type | Description |
|---|---|---|
| Dupilumab | BIOLOGICAL | Participants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28. |
| Placebo | DRUG | Normal Saline. |
Inclusion Criteria: * Male or female 18 years of age or older at the time of enrollment. * Patients hospitalized with a positive RT-PCR for SARS-CoV-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe COVID-19 infection as defined by NIH COVI...