Official Title
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.

Unknown status
COVID
Acute Respiratory Distress Syndrome

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"

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Dr. Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia

St. Carolus Hospital
Jakarta, DKI Jakarta, Indonesia

Ciputra Hospital CitraRaya
Jakarta, DKI Jakarta, Indonesia

Contacts

Robert Sinto, MD
+628158835432
rsinto@yahoo.com

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

Indonesia University
NCT Number
MeSH Terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome