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A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease

AN OPEN LABEL RANDOMISED CONTROL TRIAL ON PASSIVE IMMUNIZATION WITH CONVALESCENT PLASMA IN SEVERE COVID-19 DISEASE - PICP19

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025209
Enrollment
80
Registered
2020-05-15
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: Passive Immunization using Convalescent Plasma in COVID-19: Blood group matched convalescent Plasma (COVID Plasma) from recovered COVID-19 patients will be transfused to patients with s

Sponsors

Council of Scientific and Industrial Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted with RNA PCR proven COVID-19 with severe disease (fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 with Mild ARDS (200 mmHg =5 cm H2O, or non-ventilated) or Moderate ARDS (100 mmHg =5 cm H2O, or non-ventilated) within 5 to 10 days from initial presentation.

Exclusion criteria

Exclusion criteria: 1. Pregnant mothers 2. Patients with age less than 18 years 3. Admitted late after 10 days of initial presentation 4. Patients refusing consent

Design outcomes

Primary

MeasureTime frame
2. To compare â??all causeâ?? mortality 3. To identify the immune correlates for response to plasma therapy. Timepoint: 1. Discharge 2. Discharge/death 3. Day 0, Day 3, Day 7 after admission

Secondary

MeasureTime frame
1. To compare recovery from ARDS in both groups 2. To compare time taken to negative viral RNA PCR 3. Adverse reaction to plasma therapyTimepoint: At discharge/death

Countries

India

Contacts

Public ContactDipyaman Ganguly

Calcutta School of Tropical Medicine

jaggs.nbmc@gmail.com9830126060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026