Evaluation of the effect of plasmapheresis on patients with severe COVID-19

Phase 2

Recruiting

Conditions: Severe coronavirus disease 2019.
Coronavirus infection, unspecified
B34.2

Registration Number: IRCT20210315050710N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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/

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.