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

Primary Purpose

COVID, Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Convalescent plasma
Standard of care
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Cipto Mangunkusumo General HospitalRecruiting
  • St. Carolus HospitalRecruiting
  • Ciputra Hospital CitraRayaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

convalescent plasma and standard of care

standard of care

Arm Description

Outcomes

Primary Outcome Measures

All-cause mortality
Proportion of all-cause mortality

Secondary Outcome Measures

Length of stay in intensive care unit
Mean length of stay in intensive care unit
Duration of mechanical ventilation
Mean duration of mechanical ventilation
Body temperature (degree in Celsius)
Mean change from baseline using time series analysis
The Sequential Organ Failure Assessment (SOFA) Score
Mean change from baseline using time series analysis
PAO2/FIO2 ratio
Mean change from baseline using time series analysis
C-Reactive Protein (CRP) in mg/L
Mean change from baseline using time series analysis
D-Dimer in ng/mL
Mean change from baseline using time series analysis
Procalcitonin in ng/mL
Mean change from baseline using time series analysis
Interleukin 6 (IL-6) in pg/mL
Mean change from baseline using time series analysis
Allergic/ anaphylaxis transfusion reaction
Number of participants with allergic/ anaphylaxis transfusion reaction
Hemolytic transfusion reaction
Number of participants with Hemolytic transfusion reaction
Transfusion Related Acute Lung Injury
Number of participants with Transfusion Related Acute Lung Injury
Transfusion associated Circulatory Overload
Number of participants with Transfusion associated Circulatory Overload

Full Information

First Posted
May 4, 2020
Last Updated
August 16, 2020
Sponsor
Indonesia University
Collaborators
Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04380935
Brief Title
Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
Official Title
Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Sinto, MD
Phone
+628158835432
Email
rsinto@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andri MT Lubis, MD, PhD
Organizational Affiliation
Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Cipto Mangunkusumo General Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sinto, MD
Phone
+628158835432
Email
rsinto@yahoo.com
First Name & Middle Initial & Last Name & Degree
Andri MT Lubis, MD, PhD
First Name & Middle Initial & Last Name & Degree
Robert Sinto, MD
First Name & Middle Initial & Last Name & Degree
Elida Marpaung, MD, MBiomed
First Name & Middle Initial & Last Name & Degree
Cosphiadi Irawan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lugyanti Sukrisman, MD, PhD
First Name & Middle Initial & Last Name & Degree
Siti Rizny F Saldi, Pharm, MSc
First Name & Middle Initial & Last Name & Degree
William Djauhari, MD
Facility Name
St. Carolus Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sinto, MD
Phone
+628158835432
Email
rsinto@yahoo.com
Facility Name
Ciputra Hospital CitraRaya
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
15710
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santi Gultom, MD
Phone
+6282120683216
Email
santich.gultom@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200331-sitrep-71-covid-19.pdf?sfvrsn=4360e92b_4
Description
Coronavirus disease 2019 Situation Report
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https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000230
Description
Coronavirus disease (COVID-19) in a paucisymptomatic patient: epidemiological and clinical challenge in settings with limited community transmission, Italy, February 2020.
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https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000266
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Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020

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

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