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

Recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/08/027285

Lead Sponsor: AIIMS

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 naÃ¯ve therapy for the emerging COVID-19 in todayâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 100

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.	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.	b)To establish the highest serological dilution which can be effectively used to capture the SARS-CoV-2 antigens.

Trial Locations

Locations (1): Dept. of Transfusion Medicine, AIIMS
🇮🇳
South, DELHI, India
Dept. of Transfusion Medicine, AIIMS
🇮🇳South, DELHI, India
Diptiranjan Rout
Principal investigator
08727804293
drdiptiranjanrout@gmail.com