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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
A dose of 2x10\^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.
Hospital Vera Cruz
Campinas, São Paulo, Brazil
Hospital de Barueri
São Paulo, Brazil
IncCOR
São Paulo, Brazil
UNIFESP
São Paulo, Brazil
Change in Clinical Condition
Ordinal scale (WHO ordinal scale that measures illness severity over time)
Time frame: 10 days
Rate of mortality within 10-days
Evaluation of Pneumonia change
Time frame: 10 days
Change of Clinical symptoms - respiratory rate
Evaluation of Pneumonia change
Time frame: 10 days
Hypoxia
oxygen saturation
Time frame: 10 days
PaO2 / FiO2 ratio
oxygen saturation
Time frame: 10 days
CD4+ and CD8+ T cell count
Marker of Immunological function
Time frame: Days 1, 2, 4, 6 and 8.
Changes of blood oxygen
PaO2 / FiO2 ratio
Time frame: 10 days
Side effects in the treatment group
Number of participants with treatment-related adverse events
Time frame: 10 days
Complete blood count, cardiac, hepatic and renal profiles;
Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine
Time frame: Days 1, 2, 4, 6 and 8.
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