Status:
UNKNOWN
Convalescent Plasma as Adjunct Therapy for COVID-19
Lead Sponsor:
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Collaborating Sponsors:
Indonesian Red Cross
Eijkman Institute for Molecular Biology
Conditions:
COVID-19
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Convalescent plasma (CP) has been the subject of increasing expectation for treating coronavirus disease 2019 (COVID-19). Reports on CP transfusion have shown promising clinical improvements without s...
Detailed Description
Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread rapidly around the world, with high rates of transmission and substanti...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients with PCR-confirmed COVID-19
- Minimal age:18 years
- Agree to participate in the trial with written informed consent
- Moderate or Severe COVID-19 at the time of enrollment
- .
- A. Definition of moderate disease (according to Siddiqi et al):
- Moderate COVID-19 is defined as disease with fever, respiratory symptoms (dry cough, chest distress, or shortness of breath after activities), and pulmonary imaging findings, and at least one of the following findings:
- i) Abnormal coagulation parameters:
- D-dimer \>1 µg/mL (normal \<0.5 µg/mL)
- Prothrombin time (\>13.6 second) or International normalized ratio (INR) ≥1.8
- Thrombocyte count \<100x 10\^3/mL
- ii) Increased pro-inflammatory markers:
- C-reactive protein (CRP) ≥26.9 mg/L
- Procalcitonin ≥0.5 ng/mL,
- Lymphocyte count \<1.5x 10\^9/L) or Neutrophil/Lymphocyte ratio (NLR) \>3.3
- iii) Presence of risk factors or comorbidities:
- Age \>65 years
- Type 1 Diabetes Mellitus or type 2 Diabetes Mellitus (with any of the following: Fasting blood glucose ≥126 mg/dl, 2-h plasma glucose ≥200 mg/dL, or random plasma glucose ≥200 mg/dL, plus HbA1C \>6.5%)
- Chronic kidney disease (creatinine \>2.0 mg/dL) or with routine hemodialysis
- Chronic liver Disease with signs of liver cirrhosis; Child-Turcotte-Pugh (CTP) Class A (score 5-6) or Class B (score 7-9) or higher; or Model for End-Stage Liver Disease (MELD) score \<39
- Heart failure (New York Health Association \[NYHA\] Class I or II)
- Bronchial asthma, chronic obstructive pulmonary disease (COPD), or pulmonary tuberculosis
- Cancer (particularly patients with chemotherapy or immunotherapy)
- Immunocompromised conditions, including HIV/AIDS, post-organ transplantation, or judged by attending physician (preferable after specialist consultation)
- Long-term corticosteroid use
- autoimmune disease
- Sequential Organ Failure Assessment \[SOFA\] score ≥5.65
- Body Mass Index (BMI) ≥35 kg/m2
- B. Definition of severe COVID-19 (according to Siddiqi et al):
- Severe Covid-19 is defined as disease with a respiratory rate ≥30 breaths/min, oxygen saturation \<90% or oxygenation index (PaO2/FiO2) ≤300 mmHg, and/or lung infiltrates \>50% within 24-48 h.
- EXCLUSION CRITERIA:
- Pregnant or lactating woman
- History of transfusion reaction, blood-group incompatibility, IgA deficiency, or Allergy to Immunoglobulin-containing substances
- Concurrent participation of clinical trials of COVID-19 treatment
- Possibility of transfer to other hospital within 72 hours
- Heart Failure (NYHA Class III or higher) or other diseases with risks of volume overload
- Permanent organ failure unrelated to COVID-19, including:
- End-stage liver disease (CTP score \>10 or MELD score \>40)
- End stage renal disease with creatinine clearance \<30% or in routine dialysis
- Multiple organ failure (SOFA score ≥11)
- Concomitant condition or treatment with risks of thrombosis, e.g., cryoglobulinemia, refractory hypertriglyceridemia, or monoclonal gammopathy
Exclusion
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT04873414
Start Date
December 1 2020
End Date
December 31 2021
Last Update
June 2 2021
Active Locations (28)
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1
Sanglah Central Hospital
Denpasar, Bali, Indonesia
2
Udayana University Hospital
Denpasar, Bali, Indonesia
3
Dr. Soeradji Tirtonegoro Hospital
Klaten, Central Java, Indonesia
4
Dr. Wongsonegoro Regency Hospital
Semarang, Central Java, Indonesia, 50272