Safety of convalescent plasma (CVP) drawn from mild symptomatic COVID-19 patients.

Not Applicable

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/08/027285

Lead Sponsor: AIIMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
a)To establish the baseline titer of the convalescent plasma drawn from mild symptomatic COVID-19 patients. <br/ ><br>b)To establish the highest serological dilution which can be effectively used to capture the SARS-CoV-2 antigens. <br/ ><br>c)To establish the absence of SARS-CoV-2 RNAemia in the drawn convalescent plasma. <br/ ><br>d)To predict a serological marker to identify potential CVP donors among the recovered patients of mild COID-19.Timepoint: 6 months