COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04873414

Muhammad Karyana, MD, MKes

mkaryana@gmail.com

2021-05-05

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

- 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

2

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

18

60

Indonesia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

364

The mortality in COVID-19 patients treated with convalescent plasma

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]