Convalescent Plasma Therapy in Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04407208|
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : June 30, 2020
Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients.
The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology.
Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation.
The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response.
This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.
|Condition or disease||Intervention/treatment||Phase|
|Convalescence Corona Virus Infection Plaque||Biological: Convalescent plasma||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-arm, pre, and post-test dependent group|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Convalescent Plasma Therapy in Patients With COVID-19|
|Actual Study Start Date :||May 1, 2020|
|Actual Primary Completion Date :||June 22, 2020|
|Actual Study Completion Date :||June 22, 2020|
Experimental: Convalescent plasma recipient
Recipients receive 3 times of each 100 ml convalescent plasma on day 0, 3, and 6
Biological: Convalescent plasma
The minimum titer of specific antibody is 1/80
- Plaque reduction neutralization test (PNRT) [ Time Frame: day 7 after first transfusion ]PNRT50
- D-dimer [ Time Frame: day 1,4,7,14 after first transfusion ]Change of D-dimer compared between pre and post transfusion
- C-Reactive Protein (CRP) [ Time Frame: day 1,4,7,14 after first transfusion ]Change of CRP compared between pre and post transfusion
- International Normalized Ratio (INR) [ Time Frame: day 1,4,7,14 after first transfusion ]Change of INR compared between pre and post transfusion
- Oxygenation Index [ Time Frame: day 1,4,7,14 after first transfusion ]Change of OI compared between pre and post transfusion
- Chest X-ray [ Time Frame: day 1,4,7,28 after first transfusion ]Change of CXR with CXR covid score compared between pre and post transfusion
- severe adverse event [ Time Frame: from day 0 to 14 days after plasma transfusion ]every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness
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): NCT04407208
|Gatot Soebroto central army presidential hospital|
|Jakarta Pusat, Indonesia, 10410|
|Study Director:||Nana Sarnadi, Sp.OG||director of research and develpment|