| CTRI Number |
CTRI/2020/10/028250 [Registered on: 06/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Stem Cell Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effects of stem cells in patients with Acute Respiratory Distress syndrome caused by Pneumonia due to COVID-19 |
|
Scientific Title of Study
|
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 Caused by Pneumonia due to COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICMR/ARDS/20-21/001 ver 3 dated 25.06.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharat Damodar |
| Designation |
Consultant Hematologist and In charge BMTU |
| Affiliation |
Mazumdar Shaw Medical Centre (Unit of Narayanan Health) |
| Address |
258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
|
| Fax |
|
| Email |
sharat.damodar.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Kumar Gupta |
| Designation |
Sr VP – Medical & Regulatory Affairs |
| Affiliation |
Stempeutics Research pvt. Ltd. |
| Address |
Stempeutics Research 3rd Floor, Manipal Hospitals Whitefield Pvt.
Ltd. #143, 212-215, EPIP Industrial Area K R Puram Hobli,
Bengaluru
Bangalore
Bangalore
KARNATAKA
560 048
India |
| Phone |
8025028101 |
| Fax |
|
| Email |
pawan.gupta@stempeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Jotwani |
| Designation |
Deputy Director General (Sr. Grade) (Scientist F) |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research Department of Health Research
Ministry of Health & Family Welfare(Govt. of India) Ansari Nagar,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
1126589272 |
| Fax |
|
| Email |
cbtcovidicmr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Department of Health Research Ministry of Health & Family
Welfare(Govt. of India) Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Kumar Panigrahi |
All India Institute of Medical Sciences Bhubaneswar |
Additional Professor
Pulmonary Medicine &
Critical Care Room
No-425, 4th Floor,
Academic Block All
India institute of
Medical Sciences
Bhubaneswar
Khordha
ORISSA |
9438884282
pulmed_manoj@aiimsbhubaneswar.edu.in |
| Dr Sharat Damodar |
Narayana Hrudyalaya |
258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore
KARNATAKA |
9880437134
sharat.damodar.dr@narayanahealth.org |
| Dr Milind Nadkar |
Seth GS Medical College and KEM Hospital |
Department of Medicine, Seth GS medical College and KEM Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9820060705
milindnadkar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC-I Seth GS Medical College and KEM Hospital Mumbai |
Approved |
| Institutional Ethics Committee All India Institute of Medical Sciences Bhubaneswar |
Submittted/Under Review |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Arm |
Standard of Care |
| Intervention |
Stempeucel® |
Ex - vivo cultured allogeneic
Mesenchymal stromal cells at a
dose of 200 million cells at Day 0 and Day 3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 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.
4. Patients requiring mechanical ventilatory support.
5. Patients who can start receiving BMMSCs within 72 hours (3 days) after the diagnosis of ARDS. |
|
| ExclusionCriteria |
| Details |
Patients may not be selected if any of the following criteria are
present
1. Any other cause of ARDS not attributable to SARS-CoV2.
2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure.
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 – Pugh’s score > 12).
7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home.
8. Patients for whom one week 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 for the study drug and/or excipients. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
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
|
| Outcome |
TimePoints |
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) |
28 days efficacy & 1 year safety follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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). |