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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/05/025209
• Date of registration: 15-05-2020
• Prospective Registration: Yes
• Primary sponsor: Council of Scientific and Industrial Research
• Public title: A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease
• Scientific title: AN OPEN LABEL RANDOMISED CONTROL TRIAL ON PASSIVE IMMUNIZATION WITH CONVALESCENT PLASMA IN SEVERE COVID-19 DISEASE - PICP19
• Date of first enrolment: 20-05-2020
• Target sample size: 80
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43251
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dipyaman Ganguly
• Affiliation: Calcutta School of Tropical Medicine

• Name: Yogiraj Ray
• Affiliation: Calcutta School of Tropical Medicine

Key inclusion & exclusion 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 < 90% at room air)

with Mild ARDS (200 mmHg < PaO2/FiO2 <= 300 mmHg, with PEEP or CPAP >=5 cm H2O, or non-ventilated)

or Moderate ARDS (100 mmHg < PaO2/FiO2 <=200 mmHg, with PEEP >=5 cm H2O, or non-ventilated)

within 5 to 10 days from initial presentation.


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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 severe COVID-19 diseases
200ml COVID Plasma will be intravenously transfused once daily on two consecutive days.
Control Intervention1: Standard of care: Standard of care

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Council of Scientific and Industrial Research Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg, New Delhi â?? 110001

Ethics review

Status: Approved
Approval date: 11/05/2020
Contact:

Institutional Ethics Committee, ID and BG Hospital, Kolkata

Status: Approved
Approval date: 11/05/2020
Contact:

Institutional Ethics Committee, Medical College Hospital, Kolkata

Status: Approved
Approval date: 12/05/2020
Contact:

The Ethical Committee on Human Subjects, CSIR-Indian Institute of Chemical Biology, Kolkata

Results

• Date Completed: 15/10/2020