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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04315987 | NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia | PHASE2 | COMPLETED | 90 | — | — | Jun 30, 2020 | Feb 28, 2021 | Oct 28, 2022 | 4 | Brazil |
Ordinal scale (WHO ordinal scale that measures illness severity over time)
| Arm | Type | Description |
|---|---|---|
| NestaCell® | EXPERIMENTAL | A dose of 2x10\^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. |
| Name | Type | Description |
|---|---|---|
| NestaCell® | BIOLOGICAL | A dose of 2x10\^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects. |
| Placebo | BIOLOGICAL | Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. |
Inclusion Criteria: 1\. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation \<95%; ii...