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

NCT04380935 | Unknown Phase 2 DMC

• 1 other identifier: convalescent plasma RSCM-FKUI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Proportion of all-cause mortality

  up to 28 days

Secondary Outcomes (13)

• Length of stay in intensive care unit

  up to 28 days

• Duration of mechanical ventilation

  up to 28 days

• Body temperature (degree in Celsius)

  Day 1, 3, 5, and 7 after administration of therapy

• The Sequential Organ Failure Assessment (SOFA) Score

  Day 1, 3, 5, and 7 after administration of therapy

• PAO2/FIO2 ratio

  Day 1, 3, 5, and 7 after administration of therapy

Study Arms (2)

convalescent plasma and standard of care

EXPERIMENTAL

Biological: Convalescent plasma; Drug: Standard of care

standard of care

ACTIVE COMPARATOR

Drug: Standard of care

Interventions

Convalescent plasma BIOLOGICAL

Convalescent plasma of recovered COVID-19 patients (donor)

convalescent plasma and standard of care

Standard of care DRUG

According to national or hospital guidelines "COVID-19 Management Protocol"

convalescent plasma and standard of care; standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (3)

Dr. Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

St. Carolus Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Ciputra Hospital CitraRaya

Jakarta, DKI Jakarta, 15710, Indonesia

RECRUITING

Related Publications (20)

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Related Links

• Coronavirus disease 2019 Situation Report
• Coronavirus disease (COVID-19) in a paucisymptomatic patient: epidemiological and clinical challenge in settings with limited community transmission, Italy, February 2020.
• Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andri MT Lubis, MD, PhD

  Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital

  STUDY CHAIR

Central Study Contacts

Robert Sinto, MD

CONTACT

+628158835432; rsinto@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Division RSCM

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: May 18, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

ID (3)