CTRI Number |
CTRI/2020/04/024804 [Registered on: 22/04/2020] Trial Registered Prospectively |
Last Modified On: |
16/06/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Evaluation of safety and efficacy of convalescent plasma in COVID-19 patients |
Scientific Title of Study
Modification(s)
|
Open Label, parallel arm, phase I/II clinical trial to evaluate Safety and efficacy of Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease |
Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Identifier |
IMD/CoV/003/2020, Version 2.1, 29 Apr 2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Vishal Rao |
Designation |
Principal Investigator |
Affiliation |
HealthCare Global Enterprises Ltd. |
Address |
9/1, Kalinga Rao Road, Sampangi Rama Nagara, Bengaluru, Karnataka 560002
Bangalore KARNATAKA 560002 India |
Phone |
9739774949 |
Fax |
|
Email |
drvishal.rao@hcgel.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jyothnsa Rao |
Designation |
Co-Investigator |
Affiliation |
International Stemcell Services Ltd |
Address |
9/1, Kalinga Rao Road, Sampangi Rama Nagara, Bengaluru, Karnataka 560002
Bangalore KARNATAKA 560002 India |
Phone |
9620252285 |
Fax |
|
Email |
jyotrao@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Meena Dalal |
Designation |
CRO representative |
Affiliation |
Trial Guna |
Address |
681, 17th Cross Road, JP Nagar 6th Phase, KR Layout, Bengaluru, Karnataka- 560078
Bangalore KARNATAKA 560078 India |
Phone |
9972636265 |
Fax |
|
Email |
regulatory@trialguna.com |
|
Source of Monetary or Material Support
|
International Stemcell Services Ltd |
|
Primary Sponsor
|
Name |
International Stemcell Services Ltd |
Address |
Tower 5,
9/1, Mission Road,
Sampangi Rama Nagar,
Bangalore-560027
|
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ashish Dhoot |
H.C.G Bangalore Institute of Oncology Speciality Centre |
HCG Cancer Center
Tower 4, 2nd Floor, Room no. 221, 8 HCG Towers, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore-560027 Bangalore KARNATAKA |
9042815404
dr.adhoot@gmail.com |
Dr Ramesh Revanna |
Victoria Hospital- BMCRI |
Room No- 2, 1st floor, Next to the Deans chamber,Fort Rd, near City Market, New Tharagupet, Bengaluru, Karnataka, 560002 Bangalore KARNATAKA |
9341229228
ramesh2reva@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Ethics Committee of Bangalore Medical College & Research Institute |
Approved |
HCG Central Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
convalescent plasma |
Arm A Subjects will be administered about 500 ml of apheresis derived Convalescent plasma intravenously in a single dose along with standard care of therapy |
Comparator Agent |
standard care of therapy |
In Arm B the standard care will be as per the local hospital protocol and as per recommendations/guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA). |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
- 18 years and older (male or female)
- Laboratory confirmation of COVID – 19
- CT image is characteristic of 2019 novel corona virus pneumonia (optional)
- Sign a consent form and follow the test plan and follow-up process.
Inclusion criteria for donors of plasma
- 18 years and older (male or female)
- Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge.
- COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample.
- The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis).
- Sign a consent form and follow the test plan and follow-up process.
|
|
ExclusionCriteria |
Details |
- Patients with autoimmune disease in the past or screening
- Those who have serious disease that affect their overall survival as decided by the treating clinican
- Self reports HIV or syphilis infected persons
- Pregnant or lactating women
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months.
Exclusion criteria for donors
- Patients who become sick again after getting discharged
- RNA positive for COVID or TTI positive.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Safety, efficacy.
Side effects measured by Chest Radiograph.
Improvement of clinical symptoms including duration of fever, respiratory distress, pneumonia, cough, sneezing, and diarrhea within 3 days of the convalescent plasma transfusion.
Oxygen Saturation, Pao2/Fio2.
Decrease in viral load as detected by PCR, serum antibody titer.
Routine blood biochemical parameters including renal and liver function tests.
Sequential Organ Failure Assessment (SOFA) |
Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14
Eg. CT chest- Day -2, Day 3, Day 7 and Day 14
Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14
Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28 |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
- Rate of mortality
- Marker of immunological function, ferritin, CRP, d-dimer
- Ventilatory and extracorporeal membrane oxygenation (ECMO) supports before and after treatment |
All parameters will be assessed on Day 0, Day 1, Day 3, Day 14.
d-dimer assessed on Day 0, Day 1, Day 3, Day 14 and Day 28. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
11/05/2020 |
Date of Study Completion (India) |
23/10/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
To be filled |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Background: COVID-19 is a condition caused by infection with Corona Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates, causing a worldwide pandemic. The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel corona virus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Corona viruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it. Purpose: The objective of this study is to investigate the potential use of convalesecent plasma in patients with Corona Virus SARS-CoV-2 infection. |