Status:
UNKNOWN
Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Dr Cipto Mangunkusumo General Hospital
Fakultas Kedokteran Universitas Indonesia
Conditions:
COVID
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04380935
Start Date
May 18 2020
End Date
October 31 2020
Last Update
August 18 2020
Active Locations (3)
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1
Dr. Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
2
St. Carolus Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
3
Ciputra Hospital CitraRaya
Jakarta, DKI Jakarta, Indonesia, 15710