A study to evaluate the effects of stem cells in patients with Acute Respiratory Distress syndrome caused by Pneumonia due to COVID-19

INTERVENTION: Intervention1: Stempeucel®: Ex ‐ vivo cultured allogeneic Mesenchymal stromal cells at a dose of 200 million cells at Day 0 and Day 3 Control Intervention1: Control Arm: Standard of Care CONDITION: Health Condition 1: ‐ Health Condition 2: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: The primary efficacy endpoints are: ; i. Mechanical ventilator free days 28 days after ; administration of BMMSCs ; ii. Percent mortality 28 days after administration ; of BMMSCsTimepoint: The primary efficacy endpoints are: ; i. Mechanical ventilator free days 28 days after ; administration of BMMSCs ; ii. Percent mortality 28 days after administration ; of BMMSCs SECONDARY OUTCOME: The secondary efficacy endpoints are: ; i. Intensive care unit (ICU) free days 28 days ; after administration of BMMSCs ; ii. Vasopressor free days 28 days after ; administration of BMMSCs ; iii. Oxygen index (OI) changes (from Day 0 to Day ; 28: Day 0, 1, 3, 7, 14 and 28) ; iv. Murray lung injury score (from Day 0 to Day ; 28: Day 0, 1, 3, 7, 14 and 28) ; v. Sequential organ failure assessment score ; (SOFA score) (from Day 0 to Day 28: Day 0, 1,3, 7, 14 and 28)Timepoint: 28 days efficacy & 1 year safety follow up INCLUSION CRITERIA: Patients must satisfy all of the following criteria to be included in the study: 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) 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 pneumonia causing moderate and severe ARDS as per the Berlin ARDS definition. a. Respiratory failure within one week of a known insult or new and/or worsening respiratory symptoms b. Respiratory failure not fully explained by cardiac function or volume overload c. Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 on at least PEEP 5cmH2O: i Moderate ARDS: PaO2/FiO2 >100 mmHg and ?200 mmHg, on ventilator settings that include PEEP ?5 cm H2O