Acute Respiratory Distress Syndrome, COVID
Conditions
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.
Interventions
BIOLOGICALConvalescent plasma
Convalescent plasma of recovered COVID-19 patients (donor)
DRUGStandard of care
According to national or hospital guidelines COVID-19 Management Protocol
Sponsors
Dr Cipto Mangunkusumo General Hospital
Fakultas Kedokteran Universitas Indonesia
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | up to 28 days | Proportion of all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of stay in intensive care unit | up to 28 days | Mean length of stay in intensive care unit |
| 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 |
| Procalcitonin in ng/mL | Day 1, 3, 5, and 7 after administration of therapy | Mean change from baseline using time series analysis |
Countries
Indonesia
Contacts
Primary ContactRobert Sinto, MD
Outcome results
None listed