Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
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ClinicalTrials.gov Identifier: NCT04380935 |
Recruitment Status : Unknown
Verified August 2020 by Andri Maruli Tua Lubis, Indonesia University.
Recruitment status was: Recruiting
First Posted : May 8, 2020
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID Acute Respiratory Distress Syndrome | Biological: Convalescent plasma Drug: Standard of care | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia |
Actual Study Start Date : | May 18, 2020 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | October 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: convalescent plasma and standard of care |
Biological: Convalescent plasma
Convalescent plasma of recovered COVID-19 patients (donor) Drug: Standard of care According to national or hospital guidelines "COVID-19 Management Protocol" |
Active Comparator: standard of care |
Drug: Standard of care
According to national or hospital guidelines "COVID-19 Management Protocol" |
- All-cause mortality [ Time Frame: up to 28 days ]Proportion of all-cause mortality
- Length of stay in intensive care unit [ Time Frame: up to 28 days ]Mean length of stay in intensive care unit
- Duration of mechanical ventilation [ Time Frame: up to 28 days ]Mean duration of mechanical ventilation
- Body temperature (degree in Celsius) [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- The Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- PAO2/FIO2 ratio [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- C-Reactive Protein (CRP) in mg/L [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- D-Dimer in ng/mL [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- Procalcitonin in ng/mL [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- Interleukin 6 (IL-6) in pg/mL [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]Mean change from baseline using time series analysis
- Allergic/ anaphylaxis transfusion reaction [ Time Frame: 24 hours post-transfusion ]Number of participants with allergic/ anaphylaxis transfusion reaction
- Hemolytic transfusion reaction [ Time Frame: 24 hours post-transfusion ]Number of participants with Hemolytic transfusion reaction
- Transfusion Related Acute Lung Injury [ Time Frame: 24 hours post-transfusion ]Number of participants with Transfusion Related Acute Lung Injury
- Transfusion associated Circulatory Overload [ Time Frame: 24 hours post-transfusion ]Number of participants with Transfusion associated Circulatory Overload

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged more than equal to 18 years.
- COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR)
- Having severe pneumonia.
- PAO2 / FIO2 <300.
Exclusion Criteria:
- Contraindication to blood transfusions (fluid overload, history of anaphylaxis of blood products)
- Multiple and severe organ failure, hemodynamically unstable
- Other uncontrolled infections
- Disseminated intravascular coagulation (DIC) which requires a replacement factor/FFP
- Hemodialysis patients or CRRT (continuous renal replacement therapy)
- Active intracranial bleeding
- Significant myocardial ischemia
- Receiving tocilizumab treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380935
Contact: Robert Sinto, MD | +628158835432 | rsinto@yahoo.com |
Indonesia | |
Dr. Cipto Mangunkusumo General Hospital | Recruiting |
Jakarta, DKI Jakarta, Indonesia, 10430 | |
Contact: Robert Sinto, MD +628158835432 rsinto@yahoo.com | |
Principal Investigator: Andri MT Lubis, MD, PhD | |
Sub-Investigator: Robert Sinto, MD | |
Sub-Investigator: Elida Marpaung, MD, MBiomed | |
Sub-Investigator: Cosphiadi Irawan, MD, PhD | |
Sub-Investigator: Lugyanti Sukrisman, MD, PhD | |
Sub-Investigator: Siti Rizny F Saldi, Pharm, MSc | |
Sub-Investigator: William Djauhari, MD | |
St. Carolus Hospital | Recruiting |
Jakarta, DKI Jakarta, Indonesia, 10430 | |
Contact: Robert Sinto, MD +628158835432 rsinto@yahoo.com | |
Ciputra Hospital CitraRaya | Recruiting |
Jakarta, DKI Jakarta, Indonesia, 15710 | |
Contact: Santi Gultom, MD +6282120683216 santich.gultom@gmail.com |
Study Chair: | Andri MT Lubis, MD, PhD | Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital |
Publications:
Responsible Party: | Andri Maruli Tua Lubis, Head of Research Division RSCM, Indonesia University |
ClinicalTrials.gov Identifier: | NCT04380935 |
Other Study ID Numbers: |
convalescent plasma RSCM-FKUI |
First Posted: | May 8, 2020 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Syndrome Disease Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |