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CTRI Number  CTRI/2020/08/027285 [Registered on: 20/08/2020] Trial Registered Prospectively
Last Modified On: 21/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Safety of convalescent plasma (CVP) drawn from mild symptomatic COVID-19 patients. 
Scientific Title of Study   Study to assess and establish safety of convalescent plasma (CVP) drawn from mild symptomatic COVID-19 patients. 
Trial Acronym  mCCP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Diptiranjan Rout 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  Dept. of Transfusion Medicine, Room No. 13, Academic Block, NCI-AIIMS, Badsa, Jhajjar

Jhajjar
HARYANA
124105
India 
Phone  08727804293  
Fax    
Email  drdiptiranjanrout@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Diptiranjan Rout 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  Dept. of Transfusion Medicine, Room No. 13, Academic Block, NCI-AIIMS, Badsa, Jhajjar

Jhajjar
HARYANA
110078
India 
Phone  08727804293  
Fax    
Email  drdiptiranjanrout@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Diptiranjan Rout 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  Dept. of Transfusion Medicine, Room No. 13, Academic Block, NCI-AIIMS, Badsa, Jhajjar

Jhajjar
HARYANA
124105
India 
Phone  08727804293  
Fax    
Email  drdiptiranjanrout@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  AIIMS 
Address  Ansari Nagar, New Delhi-110029 
Type of Sponsor  Research institution and hospital 
 
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 
Diptiranjan Rout  Dept. of Transfusion Medicine, AIIMS  Ansari Nagar, New Delhi-110029
South
DELHI 
08727804293

drdiptiranjanrout@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  a) Anyone aged >18 years and <65 years;
b) Males;
c) Body weight: >50 kg;
d) Patients with complete seroconversion;
e) Written informed consent to participate in the study.
f) Confirmed previous SARS CoV-2 infection with mild symptomatology limited to: 1) cough, 2) fever, 3) myalgia, 4) sore throat, 5) chest pain or pressure, 6) congestion, 7) headache 8) diarrhoea, 9) nausea, and 10) loss of taste or smell. 
 
ExclusionCriteria 
Details  a) Anyone aged <18 years and >65 years;
b) Females;
c) Any comorbid conditions like Diabetes mellitus (uncontrolled), Hypertension (Uncontrolled), Asthma or any other respiratory conditions;
d) Patients of COVID-19 with moderate and/ or severe symptomatology;
e) Patients with no seroconversion;
f) Patients with incomplete seroconversion;
g) Failure to obtain Written informed consent;
h) Known cases of any malignancy (Cancer COVID-19).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish seroconversion in mild symptomatic COVID-19 patients and thence, to establish the safety of the convalescent plasma drawn from such patients for the therapeutic usage in other patients.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
a) To establish the baseline titer of the convalescent plasma drawn from mild symptomatic COVID-19 patients.
b) To establish the highest serological dilution which can be effectively used to capture the SARS-CoV-2 antigens.
c) To establish the absence of SARS-CoV-2 RNAemia in the drawn convalescent plasma.
d) To predict a serological marker to identify potential CVP donors among the recovered patients of mild COID-19. 
6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/08/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The coronavirus disease 2019 (COVID-19) is now a worldwide pandemic caused by the severe acute respiratory virus coronavirus 2 (SARS-CoV-2) which originated from Wuhan, China in 2019. To date, no specific treatment has been proven to be effective for COVID-19. With the recent rapid evolution of COVID-19 pandemic in India, no effective treatment and the currently observed mortalities, it is about time to consider the role of convalescent plasma (CVP) in addition to various existing measures to limit and control the infection. Convalescent plasma (CVP), obtained by collecting whole blood or plasma from a patient who has survived a previous infection and developed humoral immunity against the pathogen responsible for the disease in question, is a possible source of specific antibodies of human origin. Like blood donation programme around the world, identification, selection and recruitment of potential donors are challenging tasks. Besides, there are organizational and technological challenges in the collection, production and use of the products. The following important factors may be kept in mind when considering this treatment: (a) eligibility criteria of convalescent COVID-19 patients to donate whole blood or plasma, (b) pre-screening and pre-donation testing of convalescent COVID-19 donors; (c) criteria for collection of COVID-19 plasma; (d) post-donation treatment of plasma; and (e) recommendations for plasma transfusion. Though the CVP therapy from the pre-antibiotic era is a century old therapeutic modality, this is a naïve therapy for the emerging COVID-19 in today’s modern era of medicine. The knowledge regarding the SARS-CoV-2 is evolving every day and thence, the perception of community drifts accordingly. Patients who have recovered from COVID-19 are valuable donor source of CVP. Nevertheless, the balance between clinical benefits and associated risks of CVP in COVID-19 remains uncertain. The CVP contains the neutralising antibodies against the SARS-CoV-2 virus. The concentration of these neutralising antibodies are very important factor in deciding the dose of CVP to be transfused to the patients with COVID-19. However, inter donor variability of titer is a concern for establishing a uniform dosing for CVP transfusions. No study has been done so far in deciding upon a baseline neutralising titer in the CVP available from recovered patients. It is also postulated that the mild symptomatic COVID-19 patients will have poorer titers of neutralising antibodies in the CVP than the recovered patients with moderate and/ or severe COVID-19. However, a clinically efficacious baseline titer which may be considered adequate enough to bring the therapeutic response in patients of COVID-19, is yet to be elucidated. Thence, this study is planned to look for the baseline neutralising titers of Anti-SARS-CoV-2 antibodies in the CVPs from recovered patients of mild symptomatic COVID-19 in North India.

 
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