]>

IRCT20200927048848N3 IRCT 2021-10-10 Mashhad University of Medical Sciences Squalene for COVID-19 treatment Evaluation the Efficacy of Sublingual Squalene for Treatment of COVID-19 2021-09-23 anticipated 200 Complete https://irct.ir/trial/58346 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this intervention, evaluators and analysts are blind. 2 COVID-19. Intervention 1: Standard treatment + sublingual drop containing squalene, 15 drops for the first day of admission and then 10 drops a day for 4 days. Intervention 2: standard treatment: Since the effectiveness of antiviral drugs in reducing mortality of hospitalized patients has not been proven and on the other hand due to high costs, limited access, complications and the need for monitoring during treatment drugs such as RamedSivir, Favipiravir, protease inhibitors such as lupinavir / Ritonavir and atazanavir, interferon beta-1b and interferon beta-1e are decided separately for specific conditions. Prophylactic anticoagulant treatment in hospitalized patients is performed as follows:Heparin 5000IU SC TDS (BMI≥40: Heparin 7500 IU SC TDS)OrEnoxaparin 40 mg SC once daily (BMI ≥ 40: Enoxaparin 40 mg SC BID)Low-dose corticosteroids are prescribed only if the patient's symptoms improve and the need for oxygen persists despite supportive therapies and SpO2 <90%:Dexamethasone 8 mg intravenously daily for up to 10 days orOral prednisolone tablets 0.5mg / kg for a maximum of 10 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 Mahmoud Ebrahimi

Azadi Square, east door of the university campus

Mashhad Iran (Islamic Republic of) 9177948564 38002000 EbrahimiMH@mums.ac.ir Mashhad University of Medical Sciences scientific Mahmoud Ebrahimi

Imam Reza Square-Ibn Sina avenue

Mashhad Iran (Islamic Republic of) 913791331 051 3854450 EbrahimiMH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient with definite COVID-19 confirmed by molecular or imaging methods in which the oxygen saturation level is less than 93% (SPO2 <93%) and requires respiratory support including oxygen therapy. Patient with definite COVID-19 confirmed by molecular or imaging methods with hypotension (systolic pressure less than 90) Patient with definite COVID-19 confirmed by molecular or imaging methods with Persistence of dehydration and oral intolerance after outpatient supportive care Patient with definite COVID-19 confirmed by molecular or imaging methods who are considered as high risk patient regardless of the clinical symptoms based on the underlying disease, clinical condition, and paraclinical findings. (Uncontrolled high blood pressure, uncontrolled diabetes, obesity, etc.) 18 years no limit Both History of myocardial ischemia, heart failure and advanced COPD Dissatisfaction of the patient or the patient's companion 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 infection) History of alcohol or drug abuse Possibility of pregnancy and lactation U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Standard treatment + sublingual drop containing squalene, 15 drops for the first day of admission and then 10 drops a day for 4 days standard treatment: Since the effectiveness of antiviral drugs in reducing mortality of hospitalized patients has not been proven and on the other hand due to high costs, limited access, complications and the need for monitoring during treatment drugs such as RamedSivir, Favipiravir, protease inhibitors such as lupinavir / Ritonavir and atazanavir, interferon beta-1b and interferon beta-1e are decided separately for specific conditions. Prophylactic anticoagulant treatment in hospitalized patients is performed as follows:Heparin 5000IU SC TDS (BMI≥40: Heparin 7500 IU SC TDS)OrEnoxaparin 40 mg SC once daily (BMI ≥ 40: Enoxaparin 40 mg SC BID)Low-dose corticosteroids are prescribed only if the patient's symptoms improve and the need for oxygen persists despite supportive therapies and SpO2 <90%:Dexamethasone 8 mg intravenously daily for up to 10 days orOral prednisolone tablets 0.5mg / kg for a maximum of 10 days Fever. Timepoint: Daily for 7days. Method of measurement: thermometer. SPO2. Timepoint: daily for 7 days if hospitalization continued. Method of measurement: Pulse oxymeter. Respiratory rate. Timepoint: daily for 7 days. Method of measurement: respiration in one minute. Food tolerance. Timepoint: daily for 7 days. Method of measurement: physician judgment. Mashhad University of Medical Sciences Approved 2021-06-15 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)