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IRCT20200428047232N1 IRCT 2020-07-05 Esfahan University of Medical Sciences Effect of Thalidomide in Covid 19 pneumonia Effectiveness and safety of thalidomide in moderate COVID-19 pneumonia: A randomized clinical trial 2020-05-09 anticipated 60 Complete https://irct.ir/trial/47637 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group . The researcher begins to read the numbers in a predetermined manner and the patients are divided. 3 Pneumonia caused by Coronavirus 2019, COVID19. Intervention 1: Intervention group: Patients in this group are treated with 100 mg oral thalidomide tablets manufactured by Ibn Sina Company on a daily basis for up to fourteen days. These drugs are administered along with hydroxichloroquine tablets 200 mg two times daily for 5 days. Intervention 2: Control group: patients are treated with hydroxichloroquine tablets 200 mg two times daily for 5 days. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Samane Pourajam
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
Esfahan Iran (Islamic Republic of) 8137866515 +98 31 3337 7986 Spourajam@gmail.com Esfahan University of Medical Sciences scientific Samane Pourajam
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
Esfahan Iran (Islamic Republic of) 8137866515 +98 31 3337 7986 Spourajam@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 18-75 year old men and 50-75 year old women admitted in hospital Percentage of oxygen saturation at the time of admission: 89-85% (provided it is modified with Nazal auxiliary oxygen to more or equal to 90%) or oxygen saturation percentage of 90-93% and the number of breaths per minute more or equal to 30 Clinical manifestations associated with COVID-19 pneumonia with positive PCR test or HR-CT scan 18 years 75 years Both Previous Chronic lung disease Multi-organ failure at admission B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group are treated with 100 mg oral thalidomide tablets manufactured by Ibn Sina Company on a daily basis for up to fourteen days. These drugs are administered along with hydroxichloroquine tablets 200 mg two times daily for 5 days. Control group: patients are treated with hydroxichloroquine tablets 200 mg two times daily for 5 days. Time to reach clinical recovery. Timepoint: Daily visit in the hospital every 8 hours by the physician. Method of measurement: Pulse oximetery device. 28 days survival rate. Timepoint: Weekly up to 4 weeks from the time of hospitalization to 4 weeks after discharge. Method of measurement: Telephone call. Esfahan University of Medical Sciences Approved 2020-04-17 Ethics committee of Esfahan university of Medical sciences No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)