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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

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE May 18, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
All-cause mortality [ Time Frame: up to 28 days ]
Proportion of all-cause mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
Official Title  ICMJE Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • 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"
Study Arms  ICMJE
  • Experimental: convalescent plasma and standard of care
    Interventions:
    • Biological: Convalescent plasma
    • Drug: Standard of care
  • Active Comparator: standard of care
    Intervention: Drug: Standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert Sinto, MD +628158835432 rsinto@yahoo.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04380935
Other Study ID Numbers  ICMJE convalescent plasma RSCM-FKUI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andri Maruli Tua Lubis, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE
  • Dr Cipto Mangunkusumo General Hospital
  • Fakultas Kedokteran Universitas Indonesia
Investigators  ICMJE
Study Chair: Andri MT Lubis, MD, PhD Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital
PRS Account Indonesia University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP