NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia (HOPE)
COVID-19 Pneumonia
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
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:
- Patients with autoimmune diseases in the past or screening;
- Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
- Known or self-reported HIV or syphilis infected persons;
- Have participated in stem cell clinical research;
- Pregnant or lactating women or those who have fertility plans in the past year;
- The estimated life cycle is less than 48 hours;
- Other conditions that the researcher thinks are not suitable for participating in the experiment.
- Shock
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
Sites / Locations
- Hospital Vera Cruz
- Hospital de Barueri
- IncCOR
- UNIFESP
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
NestaCell®
Placebo
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.