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IRCT20200927048848N2 IRCT 2020-11-04 Mashhad University of Medical Sciences squalene and COVID-19 Evaluation of the effectiveness of microemulsion containing extracted squalene based on oilseeds for the treatment of COVID-19 2020-10-31 anticipated 15 Complete https://irct.ir/trial/51922 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patient symptom evaluators and data analysts will be unaware of the intervention and control groups. 3 Covid-19 disease. Intervention 1: Intervention group: main treatment plus injection of 20 mg squalene microemulsion every 8 hours for 6 days. Intervention 2: Control group: main treatment includes 150 mg chloroquine (equivalent to 250 mg chloroquine phosphate) two tablets together on the first day and then one tablet every 12 hours for a total of 10 days or hydroxychloroquine 400 mg together on the first day and then one tablet every 12 hours for 10 days + Lupinavir / Ritonavir (200/50) every 12 hours for 10 to 14 days. 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 Mahmood Ebrahimi
cardiovascular departement, Imam Reza hospital, Imam Reza square
Mashhad Iran (Islamic Republic of) 913791331 0098 51 3854450 EbrahmiMH@mums.ac.ir Mashhad University of Medical Sciences scientific Mahmood Ebrahimi
Cardiovascular departement, Imam Reza hospital
Mashhad Iran (Islamic Republic of) 913791331 0098 51 3854450 EbrahimiMH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with Covid-19 who have been confirmed by CT scan The patient has been admitted to the Intensive Care Unit (ICU) due to severe or critical condition 18 years no limit Both Known history of myocardial ischemia and heart failure and advanced COPD No consent of the patient or with the drug injection. Any mental disability that prevents effective communication. Existence of any physical disability that prevents one from performing daily activities independently. (Physical disability leads to disability before COVID-19 disease) U07.1 covid-19 disease Treatment - Drugs Treatment - Drugs Intervention group: main treatment plus injection of 20 mg squalene microemulsion every 8 hours for 6 days Control group: main treatment includes 150 mg chloroquine (equivalent to 250 mg chloroquine phosphate) two tablets together on the first day and then one tablet every 12 hours for a total of 10 days or hydroxychloroquine 400 mg together on the first day and then one tablet every 12 hours for 10 days + Lupinavir / Ritonavir (200/50) every 12 hours for 10 to 14 days Response to treatment criteria including respiratory rate, SPO2 in room air , presence or absence of fever for 2 days, oral tolerance, clinical judgment of the physician. Timepoint: Response to treatment will be evaluated daily, 24 hours after the first injection. Method of measurement: The number of breaths per minute will be counted by the evaluator, the blood oxygen level will be checked with a pulse oximeter, the fever will be measured sublingually using a mercury thermometer. Oral tolerance will also be recorded by evaluators. Response to treatment criteria include respiratory rate less than 24 per minute, SPO2 in room air >= 93%, absence of fever for 2 days, oral tolerance, clinical judgment of the physician. Timepoint: Response to treatment will be assessed daily, 24 hours after the first injection. Method of measurement: The number of breaths per minute will be counted by the evaluator, the blood oxygen level will be checked with a pulse oximeter, the fever will be measured sublingually using a mercury thermometer. Oral tolerance will also be recorded by evaluators. Mashhad University of Medical Sciences Approved 2020-10-24 Ethics committee of Mashhad University of Medival scienses GHarshi building, Daneshgah Avenue. Mashhad Razavi Khorasan Iran (Islamic Republic of)