Clinical trial NCT04380935: Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
Official title: Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID
Acute Respiratory Distress Syndrome
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
name: Fakultas Kedokteran Universitas Indonesia
First posted: 2020-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-cause mortality
timeFrame: up to 28 days
Secondary outcomes:
measure: Length of stay in intensive care unit
timeFrame: up to 28 days
measure: Duration of mechanical ventilation
timeFrame: up to 28 days
measure: Body temperature (degree in Celsius)
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: The Sequential Organ Failure Assessment (SOFA) Score
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: PAO2/FIO2 ratio
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: C-Reactive Protein (CRP) in mg/L
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: D-Dimer in ng/mL
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: Procalcitonin in ng/mL
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: Interleukin 6 (IL-6) in pg/mL
timeFrame: Day 1, 3, 5, and 7 after administration of therapy
measure: Allergic/ anaphylaxis transfusion reaction
timeFrame: 24 hours post-transfusion
measure: Hemolytic transfusion reaction
timeFrame: 24 hours post-transfusion
measure: Transfusion Related Acute Lung Injury
timeFrame: 24 hours post-transfusion
measure: Transfusion associated Circulatory Overload
timeFrame: 24 hours post-transfusion
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo General Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: St. Carolus Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Ciputra Hospital CitraRaya
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine Universitas Indonesia - Dr Cipto Mangunkusumo Hospital
name: Andri MT Lubis, MD, PhD
role: STUDY_CHAIR
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