Mesenchymal Stem Cell Therapy For Covid 19

Phase 1

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/08/027043

Lead Sponsor: eurogen Brain and Spine Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients admitted with RT-PCR confirmed COVID-19 illness.

Age: 18-65 years without any uncontrolled comorbidities like hypertension, diabetes, renal failure, etc

Written informed consent

Has any of the two

PaO2/ FiO2: 200-300

Respiratory Rate > 24/min and SaO2 <= 93% on room air

Exclusion Criteria

Pregnant women

Breastfeeding women

Critically ill patients:

P/F ratio < 200 (ARDS )

Shock (Requiring Vasopressor to maintain a MAP >= 65mmHg or MAP below 65)

Patients with other severe co-morbidities like cancer, chronic renal, chronic liver failure and chronic cardiac failure. This will not include diabetes, hypertension, etc

Participating in any other clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Avoidance of - <br/ ><br>Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days <br/ ><br>2. Oxygenation Index : SpO2 <br/ ><br>3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes, <br/ ><br>4. Troponin and Myoglobin <br/ ><br>5. Clinical measures: Fever and Respiratory Rate <br/ ><br>6.Immediate Adverse Events occurring after IV administration of MSCs <br/ ><br>7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failureTimepoint: All Days

Secondary Outcome Measures

Name	Time	Method
Time to recovery on 8 Point ordinal scale <br/ ><br>Time to symptom resolution (Fever, Cough, Shortness of Breath) <br/ ><br>Duration of Hospital stay after intervention <br/ ><br>Change in SOFA <br/ ><br>Duration of respiratory support required (Invasive mechanical ventilation and non invasive) <br/ ><br>Radiological improvement (Chest X Ray/ Chest CT scan) <br/ ><br>Duration of conversion of positive to negative Covid 19 from RT PCR <br/ ><br>Levels of CRP, IL6, TNF-alpha, Ferritin, CD3, CD4, CD4/CD8Timepoint: Lab parameters- Day 0, 2,4,6,8, 14 days <br/ ><br>Xray- 0,7,14,21,28 days and 6 months