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IRCT20201229049873N1 IRCT 2021-05-23 Shahre-kord University of Medical Sciences Infliximab effectiveness in COVID-19 patients ‏Investigation of Anti-TNF-α (Infliximab) drug effectiveness in COVID-19 patients 2021-01-22 anticipated 40 Complete https://irct.ir/trial/53791 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was performed by block stratified randomization method in which the class of material and block size of four people were considered. Male and female patients were divided into quadruple blocks, respectively. In each block, two patients were randomly assigned to the intervention group and two patients to the control group. Randomization was performed for men and women separately so those female patients and male patients were placed in blocks separately. The randomization list was extracted by the software, Blinding description: In this study, the drugs are coded A and B. None of the participants, health personnel, researchers, evaluators, and analysts know which drug code and which placebo code. 2-3 COVID-19. Intervention 1: "Intervention group:" Patients with Covid 19 who, in addition to the usual treatment regimens, receive a single dose of infliximab (4 mgr/kg) for 2 hours by infusion. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days. Intervention 2: "Control group: "Patients with Covid 19 receiving common treatment regimens also receive a placebo. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after publishing To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Jafar Majidi, Department of immunology, School of Medicine, Shahre-Kord University of Medical Sciences, Rahmatieh How to obtain: Official letter to the researchers Comments:
public Akbar Soleymani
Kashani hospital,Parastar ave
Shahre-Kord Iran (Islamic Republic of) ۸۸۱۶۷۵۸۹۱۵ +98 38 3226 4825 dr.akbarsoleymani@yahoo.com Shahre-kord University of Medical Sciences scientific Mohammad Moosavi
Hajar hospital,Parastar ave
Shahre-Kord Iran (Islamic Republic of) 8816854633 +98 38 3222 1943 moosavi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients with Covid-19 with acute respiratory symptoms between the ages of 18 and 60 who test positive for the SARS-CoV-19 virus by RT-PCR or by CT scan. Lung scan (subpleural lung involvement, bilateral circumference, and more than one area). Saturated oxygen is below 88% Respiratory rate more than 24 times per minute high CRP and D-dimer level, also ferritin above 1000 Lymphopenia with a count of less than 1100 18 years 60 years Both Patients who have a positive test for PPD, HCV, HBS Patients Have a history of neurodegenerative diseases such as multiple sclerosis Patients with heart failure, hypertension, and infections other than Covid 19 infection. U07.1 COVID-19, virus identified Treatment - Other Placebo "Intervention group:" Patients with Covid 19 who, in addition to the usual treatment regimens, receive a single dose of infliximab (4 mgr/kg) for 2 hours by infusion. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days.. "Control group: "Patients with Covid 19 receiving common treatment regimens also receive a placebo. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days. Changes in paraclinical outcomes. Timepoint: At the beginning of the study (before the intervention) and 7 and 14 days after the start of treatment. Method of measurement: Clinical and laboratory testing. Blood oxygen levels. Timepoint: At the beginning of the study (before the intervention) and 7 and 14 days after the start of treatment. Method of measurement: Pulse oximeter. Duration of hospitalization. Timepoint: From the beginning of the study. Method of measurement: Clinical and vital signs. Shahre-kord University of Medical Sciences Approved 2020-12-23 Ethics committee of Shahre-Kord University of Medical Sciences Kashani ave Shahre-Kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)