A clinical trial to evaluate the therapeutic effects of thalidomide in patients with COVID-19 infection

Determining the therapeutic effects of thalidomide in patients with pneumonia caused by Covid 19

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 66 patients that will use Balanced block randomization method for randomization

Patients with Covid 19 pneumonia admitted to Amir Al-Momenin Hospital of Arak city will be randomly divided into intervention and control groups after entering the study. The intervention group will receive thalidomide and the control group will receive placebo. Blinding in this study will be done using a placebo drug of the same shape and color as the main drug and patients, clinical caregiver and outcome assessor will not be aware of the study groups.

Inclusion criteria: onset of symptoms less than 10 days, lymphocytes less than 1000, CRP more than 1.5 times normal,Covid 19 positive pcr test, less than 93% oxygen saturation, respiratory rate less than 24 , CT scan findings in favor of infection To Covid 19. exclusion criteria: history of chronic disease, pregnancy, lactation, prone to pregnancy, ocp consumption, liver enzymes more than 5 times normal

66 patients will be divided into two groups of 33 patients. In both groups, standard and recommended drugs in the protocol of the Ministry of Health and support measures for patients will be applied simultaneously, but in the intervention group, in addition to the drugs of the protocol of the Ministry, oral thalidomide at a dose of 100 mg for 14 days (every night) Will be prescribed. The control group will also receive oral placebo for 14 days every night.

Duration of hospitalization, death rate, blood oxygen saturation, radiological changes of the lungs, laboratory tests

Balanced block randomization is used as a randomization method. Patients are divided into two groups using the above method. Therefore, six four-part combinations of intervention groups A and B are as follows : AABB, ABAB, ABBA, BBAA, BABA, BAAB. Then we assign them from the number one to six and with the table of random numbers from the right side of the selected number, move in order and select each of the numbers 1 to 6 of the above combination that appears, and the people who agree to participate in Study, fall into study groups. The allocation concealment will also be maintained in this method and the order of the quadruple compounds will also be completely hidden.

In this study, the patients are randomly assigned to different groups and physicians. The physicians, patients , nurses, primary investigators, and also researchers who collect clinical data and researchers who evaluate the treatment response will be blinded to the patient groups and treatment protocol