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IRCT20160118026097N5 IRCT 2020-09-19 Ghoum University of Medical Sciences Effect of plasmapheresis in the treatment of high-risk covid patients in Qom province Evaluation of the effectiveness of plasmapheresis treatment in comparison with standard treatment in improving the symptoms of high-risk patients 2020-03-29 anticipated 60 Complete https://irct.ir/trial/48401 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: does not have. 3 COVID19. Intervention 1: "control group:" receiving the treatment protocol of the Ministry of Health as hydroxychloroquine sulfate tablets 200 mg or two chloroquine phosphate tablets 250 mg and kaletra tablets (lupinavir / ritonavir) 50/200 mg or tablets (atazanavir / ritonavir) 300 / 100 mg. Intervention 2: "The intervention group:" receiving the treatment protocol of the Ministry of Health and plasmapheresis treatment as 2 liters daily for 3 to 5 sessions (Estimated volume of plasma (in liters) = weight 0.07 x (kg) x (1 -hematocrit) and FFP replacement method 4 units, albumin 5 vials, calcium 2 ampoules, the rest of normal serum. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have not been identified When: Start the access period 6 months after printing the results To whom: Researchers working in academic institutions. Conditions: According to cop rules Where to obtain: Refer to the email of the responsible author. How to obtain: Refer to the email of the responsible author. Comments: no

public jamshid vafaeemanesh

beheshti blv

qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2526 jvafaeemanesh@yahoo.com Ghoum University of Medical Sciences scientific jamshid vafaeemanesh

beheshti blv

qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2526 jvafaeemanesh@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Adults (defined) as older than 18 years and younger than 60 years Laboratory confirmation of Covid19 infection with reverse transcription polymerase chain reaction (RT-PCR) from oropharyngeal or nasopharyngeal swab Covid19-related new organ dysfunction, including hypoxia due to the need for supplemental oxygen to maintain oxygen saturation greater than 94%, hypotension (systolic blood pressure less than 90 mm Hg) or the need for vasopressor, an inotropic drug ( Renal impairment (increase in creatinine by more than 50% from baseline, decrease in glomerular filtration rate by more than 25% from onset or urination less than 0.5 ml / kg for 6 hours, decrease in Glasgow scale by 2 or more, ie 13 or less Out of 15 points, thrombocytopenia less than 150,000 platelets per millimeter, gastrointestinal symptoms requiring hospitalization (eg severe nausea, vomiting, diarrhea or abdominal pain) 18 years 60 years Both Sensitivity or sensitivity to Lopinavir or Ritonavir or recombinant IFN-β1b, including, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema or angioedema syndrome. Use of drugs that are contraindicated with lopinavir/ritonavir and should not be substituted or discontinued during the study period, such as inhibitors CYP3A Pregnancy-Eligible female participants of childbearing age are tested for pregnancy before enrolling in the study HIV infection is known to cause concern about the resistance to lepinavir / ritonavir if used in combination with other anti-HIV drugs. Hemoglobin under 8 Known heart failure EF under 50% According to the 31st National Guide, all vulnerable groups, such as the mentally disabled, emergency patients, or prisoners, are excluded from the study. U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs "control group:" receiving the treatment protocol of the Ministry of Health as hydroxychloroquine sulfate tablets 200 mg or two chloroquine phosphate tablets 250 mg and kaletra tablets (lupinavir / ritonavir) 50/200 mg or tablets (atazanavir / ritonavir) 300 / 100 mg. "The intervention group:" receiving the treatment protocol of the Ministry of Health and plasmapheresis treatment as 2 liters daily for 3 to 5 sessions (Estimated volume of plasma (in liters) = weight 0.07 x (kg) x (1 -hematocrit) and FFP replacement method 4 units, albumin 5 vials, calcium 2 ampoules, the rest of normal serum. The primary outcome (mortality within 30 days after hospitalization). Timepoint: After 24 hours in the hospital, every day. Method of measurement: View. Days without organ support (for example, supplemental O2, mechanical ventilation, dialysis and vasopressors). Timepoint: 28 days. Method of measurement: View. Results of RT-PCR in lower respiratory samples. Timepoint: Time interval: At the time of entering the study and one week after treatment and repetition every week until the negative sample of the period. Method of measurement: the experiment. Body Failure Assessment Scores (SOFA). Timepoint: Time frame: days 1, 3, 5, 7, 14 and 28). Method of measurement: check list. Long stay at the ICU. Timepoint: A period of one year after discharge. Method of measurement: View file. Hospital stay. Timepoint: A period of one year after discharge. Method of measurement: View file. Duration of mechanical ventilation. Timepoint: A period of one year after discharge. Method of measurement: View file. Chest radiographic findings. Timepoint: Time interval: first and 28 days later (based on pulmonary involvement and radiologist report). Method of measurement: View file. Number of patients with side effects from treatment. Timepoint: Timing: From admission to 28 days, side effects from metabolic treatment such as diabetes, hypothyroidism, hyperlipidemia, rheumatic fever, cataracts, glaucoma, cushingoid complications and gastrointestinal and skin complications. Method of measurement: Examination. ICU mortality. Timepoint: A period of one year after discharge. Method of measurement: Phone tracking. Hospital mortality. Timepoint: A period of one year after discharge. Method of measurement: Phone tracking. Ghoum University of Medical Sciences Approved 2020-04-19 Ethics committee of qom University of Medical Sciences beheshti blv qom Ghoum Iran (Islamic Republic of)