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.

The effectiveness of the triple combination of interferon beta-1B, chloroquine and coltra in the treatment and improvement of symptoms in patients with Covid 19 will be evaluated.

A randomized and prospective clinical trial study with a control group and a sample size of 82 people using a Blocked randomization method

This study will be performed at Dr.Ganjavian Hospital in Dezful in patients who have received the covid -19 treatment regimen in accordance with the country guideline without interferon beta1b control group)and with interferon beta 1b ((intervention group).

Inclusion criteria: Individuals over 18 years of age whose covid-19 disease has been confirmed by PCR test 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 exclusion criteria:History of drug allergies to similar compounds Pregnancy and lactation.Infection with other microbial or viral infections,History of heart disease

Intervention group Individuals Intervention group Approved nationally recommended hydroxychloroquine regimen as a single dose and then daily intake of Kaletra and in addition to the above treatment with interferon beta-1B (250 micrograms or 8 million subcutaneous units daily).Individuals in the control group receive only a single approved nationally recommended hydroxychloroquine regimen as a single dose and then daily consumption of Kaletra

Clinical efficacy according to clinical response based on blood oxygen saturation and changes in respiration rate)،Laboratory findings(LDH levels and changes in liver enzymes)،Duration of hospitalization and mortality rate

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.

The results of the study will be published along with the statistical analysis and method of the study.

Access to the data will be possible at the time of publication of the results of the study

University centers, medical staff and research centers

For research and practical purposes

Leila Masoudi Yekta - School of Nursing, Dezful University of Medical Sciences

The person in charge of the study will respond within 10 days upon receiving the application form.