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Convalescent Plasma Therapy in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407208
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Eijkman Institute for Molecular Biology
Information provided by (Responsible Party):
dr. Marliana Sri Rejeki, Sp.FK, Biofarma

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plaque reduction neutralization test (PNRT) [ Time Frame: day 7 after first transfusion ]
    PNRT50

  2. D-dimer [ Time Frame: day 1,4,7,14 after first transfusion ]
    Change of D-dimer compared between pre and post transfusion

  3. C-Reactive Protein (CRP) [ Time Frame: day 1,4,7,14 after first transfusion ]
    Change of CRP compared between pre and post transfusion

  4. International Normalized Ratio (INR) [ Time Frame: day 1,4,7,14 after first transfusion ]
    Change of INR compared between pre and post transfusion

  5. Oxygenation Index [ Time Frame: day 1,4,7,14 after first transfusion ]
    Change of OI compared between pre and post transfusion

  6. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COVID-19 case with RT-PCR
  • Stage IIb of COVID-19 or higher
  • Consent was given by the patient or legal guardian

Exclusion Criteria:

  • Pregnant
  • History of anaphylactic reaction in previous blood product transfusion

Information from the National Library of Medicine

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


Locations
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Indonesia
Gatot Soebroto central army presidential hospital
Jakarta Pusat, Indonesia, 10410
Sponsors and Collaborators
Biofarma
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Eijkman Institute for Molecular Biology
Investigators
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Study Director: Nana Sarnadi, Sp.OG director of research and develpment
  Study Documents (Full-Text)

Documents provided by dr. Marliana Sri Rejeki, Sp.FK, Biofarma:
Study Protocol  [PDF] May 27, 2020

Additional Information:
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Responsible Party: dr. Marliana Sri Rejeki, Sp.FK, Medical doctor, clinical pharmacologist, Biofarma
ClinicalTrials.gov Identifier: NCT04407208    
Other Study ID Numbers: 3471041S322342020040800002
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by dr. Marliana Sri Rejeki, Sp.FK, Biofarma:
COVID-19
convalescent plasma
treatment
severe ill
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Convalescence
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes