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IRCT20200921048786N1 IRCT 2020-11-11 Dezfoul University of Medical Sciences Evaluation of the effect of interferon beta-1b in the treatment of COVID-19 * Evaluation of the efficacy of the triple combination of interferon beta-1B (IFN β-1b), chloroquine and Kaletra in the treatment and improvement of symptoms in patients with covid -19: Clinical trial. 2020-09-22 anticipated 82 Complete https://irct.ir/trial/51086 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 82 eligible patients will be divided into two groups of 41 people. In 41 people in the intervention group (approved nationally approved hydroxychloroquine regimen as a single dose and then daily consumption of coltra and in addition to the above treatment with interferon beta-one B (at a dose of 250 micrograms or 8 million subcutaneous units every other day). Interferon Beta is one of the drugs of Iran Pharmaceutical Company. In order to randomly assign people to two groups and to ensure the balance of the number of people in the groups, the Block Randomization method will be used. In this study, blocks of four sizes will be created in which half of the people in each block will be randomly placed in one group and half in the other group. To do this, first identify all possible states in which half of the subjects are assigned to group A (interferon group) and the other half to group B (control group): 1-AABB 2-BBAA 3-ABAB 4-BABA 5-ABBA 6-BAAB Then, each of the 4 blocks will be assigned one of the digits 1 to 6, and from blocks 1 to 6, simple combinations (blocks) will be performed randomly using a table of random numbers. Selection of blocks will continue until 82 patients are divided into two groups of 41 intervention and control patients. The selected blocks are recorded in a sequence, and according to this sequence, the subjects will be assigned to one of the two groups A or B. The resulting sequence is first recorded in a randomized block method, and each of the letters A and B in the generated sequence, which indicates interferon reception, will be assigned a number from 1 to 82. Due to the unpredictability of the sequence created by the randomized block method, all researchers except the main researcher will be unaware of the size and order of the blocks. Both groups will be given basic treatment and in addition to the basic treatment, the intervention group will be given interferon. 3 COVID-19. Intervention 1: Individuals in the intervention group approved by the nationally approved hydroxychloroquine regimen as a single dose and then daily administration of Kaletra and in addition to the above treatment with interferon beta-one B (at a dose of 250 micrograms or 8 million subcutaneously every other day). Beta is a subsidiary of Iran Pharmaceutical Company. Intervention 2: Control group: Individuals in the control group receive only the recommended national hydroxychloroquine diet as a single dose and then daily consumption of Coltra.dose and then daily consumption of Kaletra. Yes - There is a plan to make this available What will be shared: The results of the study will be published along with the statistical analysis and method of the study. When: Access to the data will be possible at the time of publication of the results of the study To whom: University centers, medical staff and research centers Conditions: For research and practical purposes Where to obtain: Leila Masoudi Yekta - School of Nursing, Dezful University of Medical Sciences How to obtain: The person in charge of the study will respond within 10 days upon receiving the application form. Comments:
public Leila Masoudi Yekta
Azadegan Boulevard, Dezful University of Medical Sciences
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 6013 masoudiyekta@yahoo.com Dezfoul University of Medical Sciences scientific Leila Masoudi Yekta
Azadegan Boulevard, Dezful University of Medical Sciences
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 6013 masoudiyekta@yahoo.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Individuals over 18 years of age whose covid-19 disease has been confirmed by PCR test (PCR specification of the test from the Iranian manufacturer - Pishtaz Teb and performed by molecular method) and clinically severely ill o2sat below 90% despite receiving oxygen Severe bilateral pulmonary involvement Satisfaction to participate in the study Failure to receive any medication other than the standard protocol approved by the National Corona Therapy 18 years no limit Both History of drug allergies to similar compounds Pregnancy and lactation Infection with other microbial or viral infections History of heart disease U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Individuals in the intervention group approved by the nationally approved hydroxychloroquine regimen as a single dose and then daily administration of Kaletra and in addition to the above treatment with interferon beta-one B (at a dose of 250 micrograms or 8 million subcutaneously every other day). Beta is a subsidiary of Iran Pharmaceutical Company. Control group: Individuals in the control group receive only the recommended national hydroxychloroquine diet as a single dose and then daily consumption of Coltra.dose and then daily consumption of Kaletra. Clinical efficacy according to clinical response based on blood oxygen saturation. Timepoint: Daily. Method of measurement: Pulse oximetry. LDH levels. Timepoint: Three times a week. Method of measurement: laboratory test. Duration of hospitalization. Timepoint: End of treatment. Method of measurement: Patient file. Mortality rate. Timepoint: Daily. Method of measurement: Patient file. Changes in liver enzymes. Timepoint: twice a week. Method of measurement: laboratory test. Clinical efficacy of treatment regimen based on changes in respiratory rate. Timepoint: Daily. Method of measurement: Patient record and clinical examination. Lung involvement status. Timepoint: Weekly. Method of measurement: Interpretation of CT scan. Dezfoul University of Medical Sciences Approved 2020-09-21 Ethics committee of Dezful University of Medical Sciences Azadegan Boulevard dezful Khouzestan Iran (Islamic Republic of)