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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04707664 | Sargramostim Use in COVID-19 to Recover Patient Health | PHASE2 | COMPLETED | 600 | — | — | Apr 27, 2021 | Jan 31, 2022 | Feb 6, 2023 | 37 | United States, Argentina |
Percentage of patients who experience any emergency room visit or hospitalization, or death
| Arm | Type | Description |
|---|---|---|
| Sargramostim Arm | EXPERIMENTAL | Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 |
| Placebo Arm | PLACEBO_COMPARATOR | Day 1 - 5: Placebo treatment in addition to standard of care for COVID-19 |
| Name | Type | Description |
|---|---|---|
| Sargramostim | DRUG | All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days. |
| Placebo | DRUG | All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days. |
Inclusion Criteria: 1. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or a molecular test ≤5 days prior to randomization. The test should have been authorized by the relevant regulatory authority. 2. Have one or more of the following mild or moderate COVID-19 sy...