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

Universitas Indonesia60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID

Interventions

Convalescent plasmaBIOLOGICAL

Convalescent plasma of recovered COVID-19 patients (donor)

Standard of careDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Dr. Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, Indonesia

RECRUITING

St. Carolus Hospital

Jakarta, DKI Jakarta, Indonesia

RECRUITING

Ciputra Hospital CitraRaya

Jakarta, DKI Jakarta, Indonesia

RECRUITING

Outcomes

Primary Outcomes

All-cause mortality

Proportion of all-cause mortality

Time frame: up to 28 days

Secondary Outcomes

Length of stay in intensive care unit

Mean length of stay in intensive care unit

Time frame: up to 28 days

Duration of mechanical ventilation

Mean duration of mechanical ventilation

Time frame: up to 28 days

Body temperature (degree in Celsius)

Mean change from baseline using time series analysis