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| Name | Class |
|---|---|
| Cellavita Pesquisa Científica Ltda | OTHER |
| Hospital Vera Cruz | OTHER |
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This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.
The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.
MSCs have been widely used in cell-based therapy, from basic research to clinical trials Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases.
NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in previous clinical trials.
The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard treatment to treat patients with severe COVID-19 pneumonia. .
Patients included will be randomized to receive 2x10^7 cells (20 million cells) on days 1, 3, 5 and 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Condition | Ordinal scale (WHO ordinal scale that measures illness severity over time) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mortality within 10-days | Evaluation of Pneumonia change | 10 days |
| Change of Clinical symptoms - respiratory rate | Evaluation of Pneumonia change |
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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. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florentino de Araujo Cardoso Filho | Hospital Vera Cruz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vera Cruz | Campinas | São Paulo | Brazil | |||
| Hospital de Barueri |
It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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Patients will be randomized (1:1) to receive NestaCell (n=45) or Placebo (n=45).
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| Placebo | Biological | Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects. |
|
| 10 days |
| Hypoxia | oxygen saturation | 10 days |
| PaO2 / FiO2 ratio | oxygen saturation | 10 days |
| CD4+ and CD8+ T cell count | Marker of Immunological function | Days 1, 2, 4, 6 and 8. |
| Changes of blood oxygen | PaO2 / FiO2 ratio | 10 days |
| Side effects in the treatment group | Number of participants with treatment-related adverse events | 10 days |
| Complete blood count, cardiac, hepatic and renal profiles; | Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine | Days 1, 2, 4, 6 and 8. |
| São Paulo |
| Brazil |
| IncCOR | São Paulo | Brazil |
| UNIFESP | São Paulo | Brazil |