Effectiveness and safety of plasma convalescent therapy in patients with COVID-19
| ISRCTN | ISRCTN16842454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16842454 |
| Secondary identifying numbers | 003 |
- Submission date
- 28/09/2020
- Registration date
- 10/11/2020
- Last edited
- 10/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Jl. DR. Sutomo No.16, Randusari
Kec. Semarang Sel.
Kota Semarang
Jawa Tengah
Semarang
50244
Indonesia
 ORCID ID |
0000-0002-6093-5049 |
|---|---|
| Phone | +62 (0)81325062592 |
| santosaivha@fk.undip.ac.id |
Study information
| Study design | Non-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study hypothesis | There is an effect of convalescent plasma on moderate, severe, and/or critically ill patients with COVID-19. |
| Ethics approval(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 26/04/2020 |
| Overall study end date | 13/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 5 |
| Participant inclusion criteria | 1. Confirmed COVID-19 2. Clinically moderate, severe, and/or critically ill |
| 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
Study participating centre
Semarang
50244
Indonesia
Sponsor information
Government
Gedung BPPT II lantai 24, Jl. M.H. Thamrin No. 8
Jakarta
10310
Indonesia
| Phone | +62 (0)1500661 |
|---|---|
| hkli.risbang@ristekbrin.go.id | |
| Website | https://www.ristekbrin.go.id/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 20/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data will be available upon request from Ika Kartiyani (ikakartiyani@gmail.com). |
Editorial Notes
13/10/2020: Trial's existence confirmed by Ministry of Health-National Institute of Health Research and Development.
