]>
IRCT20180922041089N4 IRCT 2020-08-23 Tehran University of Medical Sciences Evaluation of the effect of oral Ivermectin on patients with COVID-19 EIC Evaluation of the effect of oral Ivermectin on the outcome of patients with COVID-19 and compare it with the effect of conucntional therapics in patients admitted to Ziaeian, Baharloo, Imam Khomeini in the spring and summer 2020 2020-04-19 anticipated 130 Complete https://irct.ir/trial/50305 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a multi-central blind one-way clinical trial. A total of 130 patients aged 18 to 50 years admitted to Ziaeian, Baharloo and Imam Khomeini Educational and Medical Centers have been shown to have Covid 19 with mild to moderate clinical manifestations. According to NEWS (mild score 1-4, average score 5-6), after obtaining written consent consciously, they are randomly divided into two groups. The person in charge of collecting patient information during admission and after evaluating drug treatments is unaware of which of the intervention or control groups the patient is in.The control group consisted of 65 patients who were treated with Hydroxychloroquine and azithromycin and the intervention group consisted of 65 patients who, in addition to the above-mentioned regimen, Ivermectin was added to the treatment protocol.This study is part of the phase 3 studies or the classic clinical trial studies, Randomization description: Patients will be divided into two groups using the black box randomization method (simple). First, patients are selected based on inclusion and exclusion criteria by the treating physician. And then are introduced to the research expert for randomization assignment. Out of 130 patients, he randomly placed 65 people in the intervention group in red and 65 people in the control group in green and informed the therapist. Patients do not know which group they are in, Blinding description: Patients in this study are blind who enter the study after obtaining informed consent without knowing what group they are in. 3 Corona virus. Intervention 1: Control group: Patients in the control group are treated with Hydroxychloroquine sulfate and Azithromycin (if there is no cardiac contraindication) according to the protocol of the Ministry of Health. Intervention 2: Intervention group: In the intervention group, in addition to medication Hydroxychloroquine sulfate and Azithromycin,Ivermectin 200 mg (four 3mg tablets in a 60 kg person) is given to the intervention group on the first day and a 3mg tablet is administered every 12 hours for 3 days from the second day.At the beginning of hospitalization NEWS of patients are checked and ECG is performed, and CBC diff test for lymphopenia, LFT, etc. (according to the ministry protocol) is also performed. Patients are compared after hospitalization for NEWS, clinical signs, and lymphocyte counts daily and CT scan is performed on the last day of hospitalization. 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 more information
public Abolfazl Zendehdel
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences scientific Abolfazl Zendehdel
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients 18 to 50 years Infected by the COVID 19 virus Patients with clinical symptoms, history of exposure to the patient and a positive RT-PCR test for Covid 19 from A laboratory or characteristic signs on a CT scan of the chest) with mild to moderate clinical manifestations according to the National Early Warning Score (NEWS) (mild: 1-4 / moderate: 5-6) Obtaining informed written consent consciously 18 years 50 years Both Severely ill and hospitalized in the intensive care unit Patients who are unable to take oral medications Patients with AST / ALT levels more than 5 times above normal Pregnant patients U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Control group: Patients in the control group are treated with Hydroxychloroquine sulfate and Azithromycin (if there is no cardiac contraindication) according to the protocol of the Ministry of Health Intervention group: In the intervention group, in addition to medication Hydroxychloroquine sulfate and Azithromycin,Ivermectin 200 mg (four 3mg tablets in a 60 kg person) is given to the intervention group on the first day and a 3mg tablet is administered every 12 hours for 3 days from the second day.At the beginning of hospitalization NEWS of patients are checked and ECG is performed, and CBC diff test for lymphopenia, LFT, etc. (according to the ministry protocol) is also performed. Patients are compared after hospitalization for NEWS, clinical signs, and lymphocyte counts daily and CT scan is performed on the last day of hospitalization. Improving clinical symptoms. Timepoint: Daily. Method of measurement: National Early Warning Score، (NEWS). Reducing the length of hospitalization. Timepoint: Daily. Method of measurement: Counting. Improving paraclinical indicators of the disease. Timepoint: Daily lymphocyte count - the last day of hospital CT scan. Method of measurement: Lymphocyte count - CT scan. Lack of response to treatment and hospitalization in the ICU. Timepoint: Daily. Method of measurement: Assessing clinical manifestations. There was no financial backer Approved 2020-04-29 Iran National Committee For Ethics in Biomedical Research 13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Between South Flamek and Zarafshan St., Shahrak Ghods Tehran Tehran Iran (Islamic Republic of)