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

Phase 2

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/10/028250
• Lead Sponsor: ICMR

Brief Summary

This is a Randomized, Controlled, Open Label, Multicentre, Two Arm, Two dosage, Phase II Study Assessing the Efficacy and Safety of Intravenous Administration of Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Patients with Acute Respiratory Distress Syndrome (ARDS) Caused by Pneumonia due to Coronavirus Disease 2019 (COVID-19).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-14
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 40

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.
• Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent.
• Patients diagnosed with COVID-19 pneumonia causing moderate and severe ARDS as per the Berlin ARDS definition.
• 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 OR ii Severe ARDS: PaO2/FiO2 ?100 mmHg on ventilator settings that include PEEP ?5 cm H2O d.
• Bilateral opacities in chest X-ray or CT scan.
• Patients requiring mechanical ventilatory support.
• Patients who can start receiving BMMSCs within 72 hours (3 days) after the diagnosis of ARDS.

Exclusion Criteria

• Patients may not be selected if any of the following criteria are present 1.
• Any other cause of ARDS not attributable to SARS-CoV2.
• Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure.
• Presence of any active malignancy.
• Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug.
• Patient with history of any stem cell transplant in the past.
• Moderate to severe liver failure (Child – Pugh’s score > 12).
• Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home.
• Patients for whom one week or longer has passed since the attachment of ventilator.
• Patient with pulmonary transplant or having history of lung lobectomy.
• Patient with clinically findings consistent with diffuse alveolar haemorrhage.
• 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.
• Patients who were resuscitated after cardio-respiratory arrest.
• Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion 15.
• Patients who are under artificial dialysis at screening.
• Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months.
• Patients with a history of myocardial infarction within 6 months before screening.
• Women of childbearing age who are not using an adequate method of contraception.
• If the patient is menopausal, it must be documented.
• Pregnancy or breast feeding.
• Patient with HIV infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoints are:	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
i. Mechanical ventilator free days 28 days after	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
administration of BMMSCs	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
ii. Percent mortality 28 days after administration	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
of BMMSCs	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 Measures

Name	Time	Method
The secondary efficacy endpoints are:	i. Intensive care unit (ICU) free days 28 days

Trial Locations

Locations (3)

All India Institute of Medical Sciences Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Narayana Hrudyalaya; 🇮🇳 Bangalore, KARNATAKA, India

Seth GS Medical College and KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

All India Institute of Medical Sciences Bhubaneswar

🇮🇳Khordha, ORISSA, India

Dr Manoj Kumar Panigrahi

Principal investigator

9438884282

pulmed_manoj@aiimsbhubaneswar.edu.in