Convalescent Plasma as Adjunct Therapy for COVID-19 (PlaSenTer)

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Moderate, Severe, Convalescent Plasma, Indonesia Read More

INCLUSION CRITERIA:

1. Patients with PCR-confirmed COVID-19
2. Minimal age:18 years
3. Agree to participate in the trial with written informed consent

4. Moderate or Severe COVID-19 at the time of enrollment

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   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