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Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380935
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : August 18, 2020
Sponsor:
Collaborators:
Dr Cipto Mangunkusumo General Hospital
Fakultas Kedokteran Universitas Indonesia
Information provided by (Responsible Party):
Andri Maruli Tua Lubis, Indonesia University

Study Description
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Brief Summary:
Corona virus disease 2019 (COVID-19) has been declared as a Pandemic by the World Health Organization (WHO). According to WHO report on March 31st 2020, globally COVID-19 have infected over 750,000 people and caused over 36,000 deaths with case fatality rate of 4.85%. In Indonesia, COVID-19 have infected 1,414 people and caused 122 deaths with case fatality rate of 8.63%. In severe cases, COVID-19 causes complications, such as acute respiratory distress syndrome (ARDS), sepsis, septic shock, and multi-organ dysfunction syndrome (MODS), where age and comorbid illnesses as a major factor to these complications. Up to this point there are several promising therapies for COVID-19 but is not yet recommended and in need of further research. The use of convalescent plasma has been approved by the US Food and Drug Administration (FDA) through the scheme of emergency investigational new drug (eIND). This method has been used as the treatment in several outbreak or plague cases over the years, such as the flu epidemic in 1918, polio, measles, mumps, SARS (severe acute respiratory syndrome), EVD (Ebola virus disease) and MERS (middle-eastern respiratory syndrome) and this treatment shows better outcome. Several case report on the use of convalescent plasma for COVID-19 patients with ARDS and mechanical ventilation has been reported and shows promising outcome. Nevertheless, larger and multicenter research need to be done to assess and evaluate the effectiveness and safety of convalescent plasma therapy on for COVID-19 patients with ARDS.

Condition or disease Intervention/treatment Phase
COVID Acute Respiratory Distress Syndrome Biological: Convalescent plasma Drug: Standard of care Phase 2 Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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"


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: up to 28 days ]
    Proportion of all-cause mortality


Secondary Outcome Measures :
  1. Length of stay in intensive care unit [ Time Frame: up to 28 days ]
    Mean length of stay in intensive care unit

  2. Duration of mechanical ventilation [ Time Frame: up to 28 days ]
    Mean duration of mechanical ventilation

  3. 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

  4. 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

  5. PAO2/FIO2 ratio [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]
    Mean change from baseline using time series analysis

  6. 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

  7. 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

  8. Procalcitonin in ng/mL [ Time Frame: Day 1, 3, 5, and 7 after administration of therapy ]
    Mean change from baseline using time series analysis

  9. 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

  10. Allergic/ anaphylaxis transfusion reaction [ Time Frame: 24 hours post-transfusion ]
    Number of participants with allergic/ anaphylaxis transfusion reaction

  11. Hemolytic transfusion reaction [ Time Frame: 24 hours post-transfusion ]
    Number of participants with Hemolytic transfusion reaction

  12. Transfusion Related Acute Lung Injury [ Time Frame: 24 hours post-transfusion ]
    Number of participants with Transfusion Related Acute Lung Injury

  13. Transfusion associated Circulatory Overload [ Time Frame: 24 hours post-transfusion ]
    Number of participants with Transfusion associated Circulatory Overload


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT04380935


Contacts
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Contact: Robert Sinto, MD +628158835432 rsinto@yahoo.com

Locations
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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   
Sponsors and Collaborators
Indonesia University
Dr Cipto Mangunkusumo General Hospital
Fakultas Kedokteran Universitas Indonesia
Investigators
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Study Chair: Andri MT Lubis, MD, PhD Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital
More Information
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Additional Information:

Publications:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury