Severe coronavirus disease 2019. Coronavirus infection, unspecified
Conditions
Interventions
Intervention group: will receive plasmapheresis in 3 consecutive days
first round after assessment of patients based on inclusion and exclusion criteria, second and third rounds 12 and 24 hours after intervention, respectively. Blood flow rate will be 200-250 ml/minutes
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Men or women 18 to 80 years old Informed consent by the phone call from relatives or legal representative Diagnosis of COVID-19 by polymerase chain reaction in nasopharynx smear, sputa, or bronchial aspiration Hospitalization in intensive care unit under invasive mechanical ventilation Acute respiratory distress syndrome (sudden and acute hypoxia Pao2/Fio2<300) and (pulse oximetry Sao2<50%) Lung bilateral opacity in computed tomography scan (during 24-48 hours that is not related to congestive heart failure) Severe pneumonia which is accompanied with fever or respiratory infection) D-dimer higher than 1000 ng/m Ferritin higher than 500 µg/L
Exclusion criteria
Exclusion criteria: Being under invasive mechanical ventilation more than 7 days Cirrhosis (de-compensated) Chronic renal failure that needs dialysis Active neoplastic disease Severe congestive heart failure (class III-IV based on The New York Heart Association {NYHA Classification}) Severe Pulmonary Disease (Sever Pulmonary Disease (GOLD III – IV)) Pregnancy Human Immunodeficiency Virus (HIV) Patients who are involved in another clinical trial Patients with high mortality who their physician believes they are expected to succumb to disease during next 24 hours Pulmonary embolism confirmation Patients with acute coronary syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammatory cytokines level (interleukin 6, 10 and Tumor Necrosis Factor Alpha). Timepoint: Before intervention, 24 and 120 hours after intervention. Method of measurement: Spectrophotometer machine.;Lung function by oxygen saturation (SPO2) level. Timepoint: Before intervention and 24 hours after intervention. Method of measurement: Spirometry machine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's recovery or death. Timepoint: Till 10 days after intervention. Method of measurement: Patient's follow-up and their clinical status.;Transferring patients to the ICU. Timepoint: Till 10 days after intervention. Method of measurement: Patient's follow-up.;Evaluation of Ferritin level in blood. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer machine.;C reactive protein level in blood. Timepoint: Before and after intervention. Method of measurement: Biochemistry auto analyzer.;C3 and C4 level. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer machine.;Complement Total (CH50) level in blood. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer machine.;Duration of hospitalization in the intensive care unit (ICU). Timepoint: Till 10 days after intervention. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohamad Eslami Jouybari
Mazandaran University of Medical Sciences
Outcome results
None listed