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CTRI Number  CTRI/2020/05/025346 [Registered on: 25/05/2020] Trial Registered Prospectively
Last Modified On: 25/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to Assess the Safety and Efficacy of Convalescent Plasma in Severe Covid-19 patients.  
Scientific Title of Study   A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma in Severe Covid-19 patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Form CT-06, No. CT/BP/07/2020   DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Latha B 
Designation  Associate Professor 
Affiliation  Rajiv Gandhi Government General Hospital, Madras Medical College, 
Address  Department of Transfusion Medicine, Rajiv Gandhi Government General Hospital, Madras Medical College, Chennai
AJ 45, 9th main road, shanthi colony, Annanagar, Chennai-40
Chennai
TAMIL NADU
600003
India 
Phone  9840313152  
Fax    
Email  latsbalu@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Anbuselvi Mattuvar Kuzhali 
Designation  Assistant Professor of physiology 
Affiliation  Madras Medical College, 
Address  Institute of Physiology and Experimental Medicine, Madras Medical College, Chennai
4B, third floor, KGEYES HYACINTH, LB road, Kamaraj Nagar, Thiruvanmiyur, Chennai
Chennai
TAMIL NADU
600003
India 
Phone  9940840760  
Fax    
Email  dranbuselvimk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrJAYANTHI RANGARAJAN 
Designation  DEAN 
Affiliation  Rajiv Gandhi Government General Hospital, Madras Medical College, 
Address  Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai
6A Sagath Srinivas 2nd Street Srinivasapuram Thiruvanmiyur 600041 Chennai
Chennai
TAMIL NADU
600003
India 
Phone  9840025339  
Fax    
Email  rjayanthi363@gmail.com  
 
Source of Monetary or Material Support  
Secretariat, Government of Tamilnadu, Namakkal Kavignar Maaligai, Fort St. George,Chennai 600 009 
 
Primary Sponsor  
Name  Government of TamilNadu 
Address  Health and Family Welfare Secretariat Chennai 600009 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Subash  Rajiv Gandhi Government General Hospital Madras Medical College  Room.No.204 Tower Block 2, ground floor, Department of Transfusion Medicine & Covid acute care facility Rajiv Gandhi Government General Hospital Madras Medical College Chennai
Chennai
TAMIL NADU 
9381715141

dchsub@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Madras Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Arm  In control arm are 30 participants who are severe Covid patients being treated in acute care facility and who will be receiving only the standardized acute care treatment for the disease  
Intervention  Treatment Arm  In treatment arm are 30 participants who are severe Covid patients being treated in acute care facility, apart from receiving standardized acute care treatment, they will also be transfused, initially with one unit of 200ml of ABO compatible convalescent plasma and subsequent dose of 200ml after 24 hours of the initial dose.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  A. INCLUSION CRITERIA FOR DONOR:
Convalescent plasma: Eligibility of Donor
Potential donors will include the following:
1. Prior diagnosis of COVID-19 documented by a laboratory test , treated and completely recovered from Covid infection.
2. Complete resolution of symptoms and at least one negative lab test for Covid-19 at least 28 days prior to donation (as per NBTC guidelines after Covid -19 pandemic for donor selection).
3. If plasma is collected prior to 28 days after full recovery from illness, then confirmation of the resolution of the infection should be obtained through demonstration of two nasopharyngeal swab tests for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs.
These individuals will be contacted telephonically and explained the details of the study and their extent of participation. If requested, they will be provided transport for the same.
Donor eligibility criteria:
The following eligibility criteria will be applied towards potential donors:
1. Only males and nulliparous female donors of weight > 55 kgs will be included.
2. Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs & Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination.
3. Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation & departmental SOPs.
4. In addition to the afore mentioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP).
a) Blood group and antibody screening – Antibody screen positive donors will be deferred.
b) Donors with Hb>12.5g/dl, platelet count>1,50,000 per microliter of blood and TLC within normal limits will be accepted.
c) Screening for HIV, HBV and HCV by serology or NAT. Donor negative by both the tests will be included.
d) Screening for syphilis and malaria by serology. Negative donors will be included
e) Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020)
f) Presence of IgG and IgM antibodies to covid-19 by quantification test as per manufacturer’s instruction. Donors negative for these will be deferred.
g) Titration of anti-covid-19 (both IgG and IgM) antibodies and SARS-CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using CLIA. If not done at the time of plasma collection the donor samples will be stored in aliquots at -80° C to be tested at a later date.
h) Molecular test for covid-19 either from nasopharyngeal swab specimens may be done depending on availability of tests. Donor’s positive will be deferred.

B. INCLUSION CRITERIA FOR RECIPIENT OF CCP:
1. Age should be above 20 years for both genders.
2. Covid positive patients who are under treatment in the covid acute care facility, amongst whom are willing to give consent to participate in this study.
3. Should be admitted in the acute care facility for the treatment of Covid-19 infection without complications.
4. Clinical symptoms suggestive of Covid infection along with confirmed laboratory diagnosis of infection with covid-19 as per ICMR/FDA guidelines.
5. Patients should be classified under severe covid-19 infection without complications criteria as judged by the qualified treating physician.

Criteria for Severe covid-19 are either one or more of the following:
1. Dyspnea should be present.
2. Respiratory rate ≥ 30/min
3. Oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
5. lung infiltrates > 50% within 24 to 48 hours. 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA FOR DONOR:
Covid-19 infected patients who are under treatment with the criteria:
1. Consecutive 2 swabs positive for covid-19
2. One molecular test for covid-19 positive – RT-PCR.
3. Clinically symptoms suggestive of covid-19.
4. Multiparous female and patient with co morbid conditions.

EXCLUSION CRITERIA FOR RECIPIENTS:
1. Patients with any past history of transfusion reactions to blood products.
2. Receipt of Pooled Immunoglobulin in last 30 days
3. Critically ill patients: respiratory failure, Sepsis, Multiorgan failure, Shock (Requiring Vasopressor to maintain a MAP ≥ 65mmHg or MAP below 65 mmHg)
4. Participating in any other clinical trial
5. Pregnant and lactating women.
6. Patients infected with Covid-19 not under criteria for severe covid condition.
7. Patients with any chronic history of coronary artery disease, coronary bypass surgery, acute pulmonary edema, Pulmonary embolism, Congestive heart failure, Malignant hypertension, Polycythemia Vera, Severe renal failure, Cirrhosis and with any implants. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To prevent progression to severe ARDS (P/F ratio 100) and all-cause Mortality at 1 month.
 
Improvement of clinical symptoms and investigations will be monitored daily for first 3 days, and on day 7, 14, 21, 28, once a month till 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Monitoring safety and efficacy pre & post-CCP transfusion:
- Duration(Days) of ICU stay/Hospital stay from symptom onset,
- Duration of mechanical ventilation(Invasive/Non-invasive).
- Incidence of transfusion reactions, ARDS & sepsis,
- Duration of clinical symptoms and Radiological improvement post transfusion
- In-hospital mortality,
- Levels of IgG antibody,neutralizing antibody titers. 
After the CCP transfusion, Serious adverse events will be noted on day 0, 3, 7, 14, 21, 28 and once a month upto 3 months. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   01/06/2020 
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="1"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet. 
Brief Summary  

SUMMARY OF STUDY DESCRIPTION:

             This study trial will provide access to convalescent plasma for patients infected with Covid-19 who are classified by a qualified physician as severe disease and also to assess the safety and efficacy of the therapy. After getting informed written consent, Patient information sheet and recruitment based on the eligibility protocol for donor / recipient,

(i) CCP will be collected from donor as per the protocol and

(ii) The participants (n=60) are severely ill Covid patients without complications being treated in acute care facility. They will be categorized into 2 (arms) groups –

a.) control group [n=30] in which Covid patients who will be receiving only the standardized acute care treatment for the disease and

b.) study group (n=30) in which Covid patients apart from receiving standardized acute care treatment, who will also be transfused with one unit of 200ml of ABO compatible convalescent plasma and subsequent dose of 200ml after 24 hours of initial dose – which (CCP) will be obtained from the donor who has recovered from documented infection with Covid-19.

         Assessment information collected will include the clinical characteristics of the patient plus if any serious adverse events confirmed to be related to the administration of covid convalescent plasma (CCP) from the day of first dose administration with periodical follow-up till 3 months.

 Other information to be collected retrospectively and for follow up will include:

 (i) Donor: sociodemographic details, clinical characteristics of the recovered patients, Covid test results with antibody titers, investigations and treatment.

       (ii) Recipient:

            Sociodemographic details,

            Covid facility resource utilization:  Clinical characteristics of the patients receiving CCP  transfusion such as Days of hospital stay and Days in ICU from symptom onset, Days of mechanical ventilation (invasive/non-invasive), Primary symptoms, associated Comorbidity, In-hospital mortality, treatment of drugs with all investigations included from the day of admission to the hospital and survival to discharge from the acute care facility.

                        Effects of CCP transfusion: Duration of clinical symptoms and Radiological improvement post transfusion, Amelioration of routine laboratory tests for covid disease. Increase in IgG and neutralizing antibody titers and disappearance of Covid-19 RNA.

                        Transfusion reactions/SAE to Covid Convalescent Plasma from the onset of CCP therapy with periodic follow up for 3months.

 
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