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IRCT20200324046852N1 IRCT 2020-04-05 Fasa University of Medical Sciences Comparison of efficacy of oral Levamisole and Formoterol+Budesonide inhaler with standard treatment of Corona infection. Evaluation of efficacy of pharmacotherapy treatment of COVID- 19 infection using oral Levamisole and Formoterol+Budesonide inhaler and comparison of this treatment protocol with standard national treatment of the disease 2020-04-01 anticipated 30 Complete https://irct.ir/trial/46706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be selected by the clinician. Each patient will be assigned an alphabetical code, a list of codes will be sent to the researcher. The researcher coded the codes from the random number table and assigned a new numeric code to each patient for each test and control group. These numerical codes will be used to form patient records and place the patient in the designed group, Blinding description: All of the research team will be blind about the groups of study and position of patients in each group except of physician and main researcher. Files of patients which will be numbered using a random number table will be sent for analyzer of the study. Information about position of patients in the groups is masked from research team. Outcomes Assessor will receive the information of patients without any name in the file. Just when statistical analysis would be finished information of groups will be revealed. 2-3 Corona virus infection. Intervention 1: Intervention group:In this group along with the standard drugs according to the national guideline of treatment for COVID-19, patients will take Levamisole 50 mg TDS for 3-7 days, made by Poursina pharmaceutical Company and Budesonide+Formoterol 1 Puff every 12 hours made by Astra Zenca Company for 3-7 days. Brand name of Budesonide+Formoterol is Symbicort and it has two strength ; 160/4.5 and 320/9 mcg respectively. Decision about the used strength and dose of drug depends on the situation of the disease and will be made by physician. Intervention 2: Control group: This group just take standard drugs consist of Kaletra and Hydroxychloroquie. This national protocol would be taken as below: 1- Hydroxychloroquine sulfate 200 mg as a single dose. 2- Kaletra tablet ( Lopinavir/ Ritonavir) 200/50 mg 2 tablets every 12 hoursfor atleast 5 days which can be extended to 14 days. Yes - There is a plan to make this available What will be shared: Just some part of data which is deductible for health care staff will be shared. When: From the 17th of April till 17th of June 2020 To whom: Just for medical proffesionals and managers of Ministry of health Conditions: Following to written approval of Research deputy of Fasa University of medical sciences Where to obtain: Research deputy of Fasa University of medical sciences How to obtain: By correspondence with the research deputy of the University and after approval requested data will be sent. Comments:
public Dr. Siamack Afazeli
Unit704, No 372, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416894438 +98 21 6647 5335 dr.afazeli@gmail.com Fasa University of Medical Sciences scientific Dr.Siamack Afazeli
Unit 704, No. 372, Felestin Ave.
Tehran Iran (Islamic Republic of) 1416894438 +98 21 6647 5335 Dr.afazeli@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) COVID-19 positive patients with positive, PCR and chest CT scan no limit no limit Both Patients with sever respiratory problems including patients with:1. Spo2<60%2. Severe respiratory distress3. Heamodynamic instabilitty 4. Acid base disturbance 5. Severe Anemia Patients with hepatic diseases Patients with Nervous system diseases U07.1 COVID-19, confirmed by laboratory testing Treatment - Drugs Treatment - Drugs Intervention group:In this group along with the standard drugs according to the national guideline of treatment for COVID-19, patients will take Levamisole 50 mg TDS for 3-7 days, made by Poursina pharmaceutical Company and Budesonide+Formoterol 1 Puff every 12 hours made by Astra Zenca Company for 3-7 days. Brand name of Budesonide+Formoterol is Symbicort and it has two strength ; 160/4.5 and 320/9 mcg respectively. Decision about the used strength and dose of drug depends on the situation of the disease and will be made by physician. Control group: This group just take standard drugs consist of Kaletra and Hydroxychloroquie. This national protocol would be taken as below: 1- Hydroxychloroquine sulfate 200 mg as a single dose. 2- Kaletra tablet ( Lopinavir/ Ritonavir) 200/50 mg 2 tablets every 12 hoursfor atleast 5 days which can be extended to 14 days. Chest CT-Scan response to treatment including dispersion size of Ground Glass area, bronchitis and consolidation. Timepoint: Days 0-3-7. Method of measurement: CT scan apparatus. Response to treatment in Lymphocytes count. Timepoint: Daily. Method of measurement: By apparatus in diagnostic lab. Response to treatment for COVID-19 specific PCR test. Timepoint: Days 0-3-7. Method of measurement: Using PCR apparatus. Response to treatment in O2 level and CO2 level in ABG or VBG test. Timepoint: Daily. Method of measurement: By apparatus in diagnostic lab. Blood pressure response to treatment. Timepoint: daily. Method of measurement: By Sphygmomanometer. Creatinine level during intervention. Timepoint: Daily. Method of measurement: By apparatus in diagnostic labs. Level of CRP ( C reactive protein) in response to intervention. Timepoint: Daily. Method of measurement: By apparatus in diagnostic labs. Fasa University of Medical Sciences Approved 2020-03-30 Ethics Committee of Fasa University of Medical Sciences Fasa University of Medical Sciences, Ebne sina Sq. Fasa Fars Iran (Islamic Republic of)