Condition category
Infections and Infestations
Date applied
28/09/2020
Date assigned
10/11/2020
Last edited
10/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
Convalescent plasma (plasma from a recovered COVID-19 patient) is a promising treatment for COVID-19. The aim of this study is to evaluate the safety and effectiveness of convalescent plasma for COVID-19 in Indonesia.

Who can participate?
Moderately, severely and critically ill COVID-19 patients

What does the study involve?
Patients who receive convalescent plasma with standard treatment are compared with patients who receive standard treatment only. The mortality (death) rate is measured using a phone call to the family after 2 months follow up.

What are the possible benefits and risks of participating?
Patients given plasma convalescent may receive immunity from COVID-19 and rapid recovery from infection. Risks include allergy, anaphylactic shock, TRALI (transfusion-related acute lung injury), and TRACO (transfusion-associated circulatory overload).

Where is the study run from?
Dr Kariadi Hospital (Indonesia)

When is the study starting and how long is it expected to run for?
April 2020 to December 2020

Who is funding the study?
BRIN (Ministry of Research and Technology)/LPDP (Educational Fund Management Institution) (Indonesia)

Who is the main contact?
Dr Damai Santosa
santosaivha@fk.undip.ac.id

Trial website

Contact information

Type

Scientific

Primary contact

Dr Damai Santosa

ORCID ID

https://orcid.org/0000-0002-6093-5049

Contact details

Jl. DR. Sutomo No.16
Randusari
Kec. Semarang Sel.
Kota Semarang
Jawa Tengah
Semarang
50244
Indonesia
+62 (0)81325062592
santosaivha@fk.undip.ac.id

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

003

Study information

Scientific title

Efficacy and safety of convalescent plasma transfusion administered as adjunctive treatment to standard treatment in moderate, severe, and/or critically ill patients with COVID-19

Acronym

Study hypothesis

There is an effect of convalescent plasma on moderate, severe, and/or critically ill patients with COVID-19.

Ethics approval

Approved 09/05/2020, Ministry of Health-National Institute of Health Research and Development (Jl Percetakan Negara No. 29 Jakarta 10560, Postcode: 1226; +62 (0)214261088; scsban@litbang.depkes.go.id), ref: LB.02.01/KE 351/2020

Study design

Non-randomized trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Patients are given convalescent plasma (200 ml with IgG SARS-CoV-2 level of 1/80) intravenously as an adjunctive treatment to standard treatment.

For the control group, the researchers use a historical control group that matches with the treatment group.

Total treatment duration: 5 days
Total follow up: 2 months

Intervention type

Biological/Vaccine

Phase

Not Applicable

Drug names

Convalescent plasma

Primary outcome measure

Mortality rate measured using a phone call to the family after 2 months follow up

Secondary outcome measures

1. Duration on ventilator measured as the time from intubation to the time of final extubation (days)
2. Length of stay measured by the duration of a single episode of hospitalization (days)
3. Organ failure measured using SOFA score at the day before transfusion, day 1, day 2, and day 7 after convalescent plasma administration 0-24)
4. Levels of F-VIII measured using 2 stage assays at the day before transfusion, day 1, day 2, and day 7 after the convalescent plasma administration
5. Levels of IgG antibody SARS-CoV-2 measured by chemiluminescence microparticle immunoassay (CMIA) on the day before transfusion, day 1, day 2, and day 7 after the convalescent plasma administration
6. Levels of coagulation parameter (D-Dimer) measured by agglutination at the day before transfusion, day 1, day 2, and day 7 after the convalescent plasma administration
7. Levels of IL- 6 measured by enzyme immunoassays at the day before transfusion, day 1, day 2, and day 7 after the convalescent plasma administration

Overall trial start date

26/04/2020

Overall trial end date

13/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed COVID-19
2. Clinically moderate, severe, and/or critically ill

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5

Participant exclusion criteria

1. History of allergy to plasma
2. Patient with an estimated poor prognosis with sofa score >11, risk of mortality 53%

Recruitment start date

19/05/2020

Recruitment end date

12/12/2020

Locations

Countries of recruitment

Indonesia

Trial participating centre

Dr Kariadi Hospital
Jl. Dr. Sutomo no 16
Semarang
50244
Indonesia

Sponsor information

Organisation

Ministry of Research and Technology/National Research and Innovation Agency (Kementerian Riset dan Teknologi Republik Indonesia)

Sponsor details

Gedung BPPT II lantai 24
Jl. M.H. Thamrin No. 8
Jakarta
10310
Indonesia
+62 (0)1500661
hkli.risbang@ristekbrin.go.id

Sponsor type

Government

Website

https://www.ristekbrin.go.id/

Funders

Funder type

Government

Funder name

KEMENRISTEK/BRIN Indonesia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
Data will be available upon request from Ika Kartiyani (ikakartiyani@gmail.com).

Intention to publish date

20/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/10/2020: Trial's existence confirmed by Ministry of Health-National Institute of Health Research and Development.