COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48119

Dr Geeta Jotwani

pawan.gupta@stempeutics.com

2020-10-06

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Patients must satisfy all of the following criteria to be included in the <br/ >study: <br/ >1. Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain <br/ >reaction (RT-PCR) assay. <br/ >2. Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent. <br/ >3. Patients diagnosed with COVID-19 pneumonia causing moderate and severe ARDS as per the Berlin ARDS definition. <br/ >a. Respiratory failure within one week of a known insult or new and/or worsening respiratory symptoms <br/ >b. Respiratory failure not fully explained by cardiac function or volume overload <br/ >c. Moderate to severe hypoxemia must be present, defined as the <br/ >ratio of PaO2/FiO2 on at least PEEP 5cmH2O: <br/ >i Moderate ARDS: PaO2/FiO2 >100 mmHg and ?200 mmHg, on <br/ >ventilator settings that include PEEP ?5 cm H2O OR <br/ >ii Severe ARDS: PaO2/FiO2 ?100 mmHg on ventilator settings that include PEEP ?5 cm H2O <br/ >d. Bilateral opacities in chest X-ray or CT scan. <br/ >4. Patients requiring mechanical ventilatory support. <br/ >5. Patients who can start receiving BMMSCs within 72 hours (3 days) after the diagnosis of ARDS.

Patients may not be selected if any of the following criteria are <br/ >present <br/ >1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ >2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ >3. Presence of any active <br/ >malignancy. <br/ >4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ >5. Patient with history of any stem cell transplant in the past. <br/ >6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ >7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ >8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ >9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ >10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ >11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ >(ECMO) at screening or currently receiving ECMO. <br/ >13. Patients who were resuscitated after cardio-respiratory arrest. <br/ >14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ >15. Patients who are under artificial dialysis at screening. <br/ >16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ >17. Patients with a history of myocardial infarction within 6 months before screening. <br/ >18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ >19. Pregnancy or breast feeding. <br/ >20. Patient with HIV infection. <br/ >21. Patient expected to have hypersensitivity for the study drug and/or excipients.

2

ICMR

18

65

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

The primary efficacy endpoints are: <br/ >i. Mechanical ventilator free days 28 days after <br/ >administration of BMMSCs <br/ >ii. Percent mortality 28 days after administration <br/ >of BMMSCsTimepoint: The primary efficacy endpoints are: <br/ >i. Mechanical ventilator free days 28 days after <br/ >administration of BMMSCs <br/ >ii. Percent mortality 28 days after administration <br/ >of BMMSCs

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 65, "treatment_name": "Allogeneic mesenchymal stem cell", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]