ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2020/04/024775
Date of registration:	21-04-2020
Prospective Registration:	Yes
Primary sponsor:	Indian Council Of Medical Research
Public title:	Study to assess the efficacy and safety of convalescent plasma in moderate COVID-19 disease.
Scientific title:	A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease. - PLACID
Date of first enrolment:	22-04-2020
Target sample size:	452
Recruitment status:	Completed
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43149
Study type:	Interventional
Study design:	Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable
Phase:	Phase 2

Countries of recruitment
India

Contacts

Name:	Dr Anup Agarwal
Address:	Ansari Nagar, New Delhi 110029 New Delhi, DELHI India
Telephone:	8582932607
Email:	mailanupagarwal@gmail.com
Affiliation:	Indian Council of Medical Research

Name:	Dr Anup Agarwal
Address:	Ansari Nagar, New Delhi 110029 New Delhi, DELHI India
Telephone:	8582932607
Email:	mailanupagarwal@gmail.com
Affiliation:	Indian Council of Medical Research

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients admitted with RT-PCR confirmed COVID-19 illness.

2. Age > 18 years

3. Has any of the two

a. PaO2/ FiO2: 200-300

b. Respiratory Rate > 24/min and SaO2 < 93% on room air

4. Availability of matched donor plasma at the point of enrolment

Exclusion criteria: 1. Pregnant women

2. Breastfeeding women

3. Known hypersensitivity to blood products

4. Receipt of pooled immunoglobulin in last 30 days

5. Critically ill patients:

a. P/F ratio <200 (moderate - severe ARDS)

b. Shock

6. Participating in any other clinical trial

7. Clinical status precluding infusion of blood products

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: Convalescent plasma: Convalescent plasma, 2 doses of 200 mL each, from recovered COVID-19 patient.
Control Intervention1: Usual care for COVID-19 disease: Usual care for COVID-19 disease

Primary Outcome(s)

The primary outcome is a composite measure of the avoidance of -

1. Progression to severe ARDS (P/F ratio 100) or

2. All-cause Mortality at 28 days

Timepoint: 28 days from intervention

Secondary Outcome(s)

Change in oxygen requirement post transfusionTimepoint: 0,1,3,5,7,14

Length of hospital stayTimepoint: Length of hospital stay

Pre and post transfusion antibody titers (IgG) in recipient plasma

Timepoint: 0,3,7 days

5. Duration of respiratory support required

a. Duration of Invasive Mechanical Ventilation

b. Duration of Non-Invasive

Timepoint: 5. Duration of respiratory support required

a. Duration of Invasive Mechanical Ventilation

b. Duration of Non-Invasive

Adverse events (AE) associated with transfusionTimepoint: Adverse events (AE) associated with transfusion

Need of Vasopressor useTimepoint: Need of Vasopressor use

Radiological improvementTimepoint: 0,3,7 days

Correlation between viral neutralization titer and Elisa antibody assay in donor plasmaTimepoint: Correlation between viral neutralization titer and Elisa antibody assay in donor plasma

1. Time to symptom resolution

a. Fever

b. Shortness of Breath

c. Fatigue

Timepoint: 1,3,5,7,14 days

Change in SOFA pre and post transfusionTimepoint: 0,1,3,5,7,14

To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR transfusion]Timepoint: Days 0, 3, and 7

Correlation between IgG antibody in donor plasma and recipient plasma after transfusion.Timepoint: 0, 1,3,7

Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusionTimepoint: 0, 3

Secondary ID(s)

Protocol v 1.1 dated 12/04/20

Source(s) of Monetary Support

Indian Council of Medical Research, Ansari Nagar, New Delhi-110029

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 30/03/2020
Contact:

Tirunelvelli Medical College

Status: Approved
Approval date: 13/04/2020
Contact:

Karnataka Institute of Medical Sciences, Hubli

Status: Approved
Approval date: 16/04/2020
Contact:

Gandhi Medical College, Secunderabad

Status: Approved
Approval date: 19/04/2020
Contact:

Smt NHL Municipal Medical College, Ahmedabad

Status: Approved
Approval date: 20/04/2020
Contact:

B.J. Medical College and Civil Hospital, Ahmedabad

Status: Approved
Approval date: 20/04/2020
Contact:

Institutional Ethics Committee SMS Jaipur

Status: Approved
Approval date: 20/04/2020
Contact:

Satguru Pratap Singh Hospital, Ludhiana

Status: Approved
Approval date: 21/04/2020
Contact:

Madras Medical College.Chennai