Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
- Conditions
- COVIDAcute Respiratory Distress Syndrome
- Interventions
- Biological: Convalescent plasmaDrug: Standard of care
- Registration Number
- NCT04380935
- Lead Sponsor
- Indonesia University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description convalescent plasma and standard of care Convalescent plasma - convalescent plasma and standard of care Standard of care - standard of care Standard of care -
- Primary Outcome Measures
Name Time Method All-cause mortality up to 28 days Proportion of all-cause mortality
- Secondary Outcome Measures
Name Time Method Length of stay in intensive care unit up to 28 days Mean length of stay in intensive care unit
Duration of mechanical ventilation up to 28 days Mean duration of mechanical ventilation
Body temperature (degree in Celsius) Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
The Sequential Organ Failure Assessment (SOFA) Score Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
PAO2/FIO2 ratio Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
C-Reactive Protein (CRP) in mg/L Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
D-Dimer in ng/mL Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
Procalcitonin in ng/mL Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
Interleukin 6 (IL-6) in pg/mL Day 1, 3, 5, and 7 after administration of therapy Mean change from baseline using time series analysis
Allergic/ anaphylaxis transfusion reaction 24 hours post-transfusion Number of participants with allergic/ anaphylaxis transfusion reaction
Hemolytic transfusion reaction 24 hours post-transfusion Number of participants with Hemolytic transfusion reaction
Transfusion Related Acute Lung Injury 24 hours post-transfusion Number of participants with Transfusion Related Acute Lung Injury
Transfusion associated Circulatory Overload 24 hours post-transfusion Number of participants with Transfusion associated Circulatory Overload
Trial Locations
- Locations (3)
Dr. Cipto Mangunkusumo General Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia
St. Carolus Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia
Ciputra Hospital CitraRaya
🇮🇩Jakarta, DKI Jakarta, Indonesia