Health Condition 1: J80- Acute respiratory distress syndrome Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Stempeucel�® (Ex - vivo cultured allogeneic Mesenchymal stromal cells): Dose of 200 million cells at Day 0 and Day 4 �± 1 day IV infusion ( total of two infusion)
Control Interventi
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)/TrueNat/CBNAAT assay. 2. Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent. 3. Patients diagnosed with COVID-19 causing moderate and severe ARDS as per the Berlin ARDS definition. a. Respiratory failure within one week of a known clinical insult or new and/or worsening respiratory symptoms b. Respiratory failure not fully explained by cardiac failure or fluid overload c. Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 with PEEP �5 cmH2O or non-ventilated � Moderate ARDS: PaO2/FiO2 >100 mmHg and �200 mmHg with PEEP �5 cmH2O, or non-ventilated or Severe ARDS: PaO2/FiO2 �100 mmHg with PEEP �5 cmH2O, or non-ventilated d. Bilateral opacities 4. Patients who can start receiving BMMSCs within 72 hours after the diagnosis of ARDS
Exclusion criteria
Exclusion criteria: 1. Any other cause of ARDS not attributable to SARS-CoV2. 2. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments in the opinion of the investigator. 3. Presence of any active malignancy. 4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. 5. Patient with history of any stem cell transplant in the past. 6. Moderate to severe liver failure (Child ââ?¬â?? Pughââ?¬•s score > 12). 7. Patient with chronic respiratory disease or use of ventilator at home. 8. Patients for whom 72 hours or longer has passed since the attachment of ventilator. 9. Patient with pulmonary transplant or having history of lung lobectomy. 10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. 11. Patients with mean arterial (blood) pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening or currently receiving ECMO. 13. Patients who were resuscitated after cardio-respiratory arrest. 14. Patients with uncontrolled co-morbidities like hypertension, diabetes mellitus etc., as per investigator discretion 15. Patients who are under artificial dialysis at screening. 16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. 17. Patients with a history of myocardial infarction within 6 months before screening. 18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. 19. Pregnancy or breast feeding. 20. Patient with HIV infection. 21. Patient expected to have hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent mortality 28 days after administration of BMMSCsTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU free days 28 days after administration of BMMSCs Number of days alive and off ventilatory support at 28 days Oxygen index changes (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge) APACHE II score (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge) SOFA score (from Day 0 to Day 14: Day 0, 1, 4, 7 and 14 or on the day of hospital discharge) Mortality at Day 56 and Day 84 Timepoint: 28 days efficacy & 1 year safety follow up | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research
Outcome results
None listed