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

August 16, 2020 updated by: Andri Maruli Tua Lubis, Indonesia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Dr. Cipto Mangunkusumo General Hospital
        • Contact:
        • 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
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • St. Carolus Hospital
        • Contact:
      • Jakarta, DKI Jakarta, Indonesia, 15710
        • Recruiting
        • Ciputra Hospital CitraRaya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: up to 28 days
Proportion of all-cause mortality
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in intensive care unit
Time Frame: up to 28 days
Mean length of stay in intensive care unit
up to 28 days
Duration of mechanical ventilation
Time Frame: up to 28 days
Mean duration of mechanical ventilation
up to 28 days
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
Day 1, 3, 5, and 7 after administration of therapy
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
Day 1, 3, 5, and 7 after administration of therapy
PAO2/FIO2 ratio
Time Frame: Day 1, 3, 5, and 7 after administration of therapy
Mean change from baseline using time series analysis
Day 1, 3, 5, and 7 after administration of therapy
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
Day 1, 3, 5, and 7 after administration of therapy
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
Day 1, 3, 5, and 7 after administration of therapy
Procalcitonin in ng/mL
Time Frame: Day 1, 3, 5, and 7 after administration of therapy
Mean change from baseline using time series analysis
Day 1, 3, 5, and 7 after administration of therapy
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
Day 1, 3, 5, and 7 after administration of therapy
Allergic/ anaphylaxis transfusion reaction
Time Frame: 24 hours post-transfusion
Number of participants with allergic/ anaphylaxis transfusion reaction
24 hours post-transfusion
Hemolytic transfusion reaction
Time Frame: 24 hours post-transfusion
Number of participants with Hemolytic transfusion reaction
24 hours post-transfusion
Transfusion Related Acute Lung Injury
Time Frame: 24 hours post-transfusion
Number of participants with Transfusion Related Acute Lung Injury
24 hours post-transfusion
Transfusion associated Circulatory Overload
Time Frame: 24 hours post-transfusion
Number of participants with Transfusion associated Circulatory Overload
24 hours post-transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Dr Cipto Mangunkusumo General Hospital
Fakultas Kedokteran Universitas Indonesia

Investigators

  • Study Chair: Andri MT Lubis, MD, PhD, Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 18, 2020

Primary Completion (ANTICIPATED)

October 31, 2020

Study Completion (ANTICIPATED)

October 31, 2020

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • convalescent plasma RSCM-FKUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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