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IRCT20190810044500N7 IRCT 2020-09-19 Yazd University of Medical Sciences Evaluation of Levamisole efficacy in treatment of Covid-19 Evaluation of Levamisole efficacy and safety in combination with routine therapy in patients with Covid-19: a clinical trial 2020-04-08 anticipated 50 Complete https://irct.ir/trial/46826 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients who enter this study will complete and sign the consent form.A questionnaire is designed to provide information about the patient's condition, and all patients are asked all questions about entry and exit conditions, and on the basis of which consultation with a physician is decided on whether or not to enter the patient.After identifying and selecting the patients, they were given written consent (after being explained by the student about its content) and the eligible patients entered the baseline phase and then randomly entered into the study to receive one of the interventions.Patients included in the study will be selected from referrals to the Infectious Disease Clinic of Shahid Sadoughi Hospital in Yazd and will be randomly selected. Plasbo is prepared in the Pharmaceutical Laboratory of Shahid Sadoughi School of Pharmacy, Yazd, Randomization description: Patients will be randomly divided into two groups by the permissive block method(25 people per group), Blinding description: All stages will be covered by the patient, physician,First performer, statistical consultant and evaluator. The first presenter identifies the sequence of assignment of patients according to the order of entry of the patients to the study and places the drugs in a uniform envelope for the patient's 5-day intake and identifies them with A or B codes. He then identifies the medications that are appropriate for each individual according to the above description and puts them in special envelopes and delivers them to patients. 2 COVID-19. Intervention 1: Control group: Routine treatment includes hydroxychloroquine 200 mg twice daily for 5 days with acetaminophen 4 mg used during fever and diphenhydramine syrup 10 cc every 8 hours to control cough. Intervention 2: Intervention group: Patients in the levamisole group receive 50 mg tablets orally three times daily for three days along with routine treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Amirreza Roustaei Firouzabad
yazd- yazd-shohaday gomnam blvd-shahid sadoughi university of medical sciences
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 amirroostaei93@gmail.com Yazd University of Medical Sciences scientific Fateme Saghafi
yazd- yazd-shohaday gomnam blvd-shahid sadoughi university of medical sciences
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 Saghfi.Fa@gmail.comhs Yazd University of Medical Sciences Iran (Islamic Republic of) Ages 18 to 60 years Diagnosis of Covid-19 over the past 24 hours Female patients are not exposed to pregnancy and do not become pregnant until thirty days later. Not taking levamisole for the past five days (due to 16-hour drug half-life) Patients suspected to covid-19 based on clinical signs and symptoms of CT scan and candidate for outpatient treatment No medication other than protocol No underlying disease 18 years 60 years Both Hospitalized Patients Patients with hemodynamic instability History of cirrhosis, hepatitis and severe liver disease, severe renal failure (less than 30ml / min) Patients currently taking levamisole for other uses such as parasitic infection Patients with a history of allergic reaction or sensitivity to levamisole Patients receiving chemotherapy for cancer Pregnancy and lactation Ages less than 18 years and over 60 years Patients with underlying diseases including diabetes and hypertension B34.2 Coronavirus infection, unspecified Placebo Treatment - Drugs Control group: Routine treatment includes hydroxychloroquine 200 mg twice daily for 5 days with acetaminophen 4 mg used during fever and diphenhydramine syrup 10 cc every 8 hours to control cough. Intervention group: Patients in the levamisole group receive 50 mg tablets orally three times daily for three days along with routine treatment. Clinical symptoms include fever, cough, shortness of breath. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Clinical examination. Patients need to be hospitalized. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Clinical examination. Mortality. Timepoint: after completion of the intervention. Method of measurement: Clinical examination. Side effects that occur during treatment or severe side effects that lead to discontinuation of treatment. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Clinical examination. Yazd University of Medical Sciences Approved 2020-06-22 Ethics Committee of Shahid Sadoughi University of Medical Sciences yazd،shohaday gomnam blvd،shahid sadoughi university of medical sciences Yazd Yazd Iran (Islamic Republic of)