Effectiveness and safety of plasma convalescent therapy in patients with COVID-19

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16842454

Enrollment

Registered

2020-11-10

Start date

2020-05-19

Completion date

Unknown

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

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 researcher

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mortality rate measured using a phone call to the family after 2 months follow up	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026