Effectiveness and safety of plasma convalescent therapy in patients with COVID-19
| ISRCTN | ISRCTN16842454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16842454 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 003 |
| Sponsor | Ministry of Research and Technology/National Research and Innovation Agency (Kementerian Riset dan Teknologi Republik Indonesia) |
| Funder | KEMENRISTEK/BRIN Indonesia |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Convalescent plasma |
| Primary outcome measure(s) |
Mortality rate measured using a phone call to the family after 2 months follow up |
| Key secondary outcome measure(s) |
1. Duration on ventilator measured as the time from intubation to the time of final extubation (days) |
| Completion date | 13/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 5 |
| Key inclusion criteria | 1. Confirmed COVID-19 2. Clinically moderate, severe, and/or critically ill |
| Key exclusion criteria | 1. History of allergy to plasma 2. Patient with an estimated poor prognosis with sofa score >11, risk of mortality 53% |
| Date of first enrolment | 19/05/2020 |
| Date of final enrolment | 12/12/2020 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Semarang
50244
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Data will be available upon request from Ika Kartiyani (ikakartiyani@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/10/2020: Trial's existence confirmed by Ministry of Health-National Institute of Health Research and Development.
