Convalescent Plasma treatment trial in COVID 19 patients

Convalescent Plasma to Limit Coronavirus Associated Complications: An Open label Clinical Study of Anti-SARS-CoV-2 Plasma in Hospitalized Patients with COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025299

Enrollment

Registered

2020-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Convalescent Plasma: SARS-CoV-2 convalescent plasma (single unit

additional unit will be given only if required based on subjectâ??s clinical status) Control Intervention1: COVID Standard treatment: As per Revised Guidelines on ClinicalManagement of COVID â?? 19

Government of India Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division)

31st March 2020

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female, aged between 18 to 75 years (both inclusive) 2.Hospitalized with RT-PCR confirmed COVID-19 illness and has any one of the below mentioned two: PaO2/ FiO2 Respiratory Rate > 24/min and SaO2 3.Subject or LAR agree to provide a signed written informed consent prior to any study specific procedures and also agree to comply with study requirements

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Receipt of pooled immunoglobulin in past 30 days 2.Contraindication to transfusion or history of prior reactions to transfusion blood products 3.Critically ill patients: PaO2/ FiO2 ratio Shock 4.Participating in any other clinical trial 5.Clinical status precluding infusion of blood products 6.Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period

Design outcomes

Primary

Measure	Time frame
Avoidance of progression to severe ARDSTimepoint: day 28	—

Secondary

Measure	Time frame
1.Improvement in symptoms and radiological findings 2.Change and duration of RT-PCR test turning negative 3.Change in anti-SARS-CoV-2 titers pre and post plasma transfusion 4.Evaluate hospital and ICU mortality and length of stay 5.Evaluate duration and type (invasive or non-invasive) of ventilation support needed 6.28 days mortality Timepoint: 28 days	—

Countries

India

Contacts

Public ContactDr AjayKumar R Yadav

Wockhardt Limited

abhatia@wockhardt.com02226534444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026