Evaluation the Efficacy of Sublingual Squalene for Treatment of COVID-19
Design
Clinical trial with control group, with parallel groups, single-blind, cluster sampling, phase2 on 200 patients
Settings and conduct
The study will be conducted in public hospitals under the auspices of Mashhad University of Medical Sciences. Individuals with inclusion criteria according to the variables of age, underlying disease and disease severity will be divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Molecularly confirmed COVID-19 disease or imaging over 18 years of age who need to be admitted to the ward for one of the following reasons: 1. Oxygen saturation level less than 93% (SPO2 <93%) and need support Respiratory) includes oxygen therapy (2. Decreased level of consciousness 3. Hypotension 4. dehydration and oral intolerance 5. Regardless of clinical symptoms based on underlying disease, clinical condition and paraclinical findings, be considered a High Risk patient. (Uncontrolled high blood pressure, uncontrolled diabetes, obesity, etc.)
Criteria for not entering:
1. History of myocardial ischemia, heart failure, and advanced COPD. 2. Patient or patient dissatisfaction. 3. Any mental disability that impedes effective communication. 4. The existence of any physical disability that prevents the independent performance of daily activities. (Physical disability leads to disability before coronary heart disease). 5. Possibility of pregnancy and lactation 6. History of alcohol or drug abuse
Intervention groups
1. Controls who will receive only standard treatment
2. Cases who will receive squalene as well as standard treatment
Main outcome variables
Fever; SPO2; Oral tolerance; Respiratory rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200927048848N3
Registration date:2021-10-10, 1400/07/18
Registration timing:registered_while_recruiting
Last update:2021-10-10, 1400/07/18
Update count:0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Mahmoud Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 5985
Email address
ebrahimimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Efficacy of Sublingual Squalene for Treatment of COVID-19
Public title
Squalene for COVID-19 treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.)
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this intervention, evaluators and analysts are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.MUMS.REC.1400.143
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
fever
Timepoint
Daily for 7days
Method of measurement
thermometer
2
Description
SPO2
Timepoint
daily for 7 days if hospitalization continued
Method of measurement
Pulse oxymeter
3
Description
respiratory rate
Timepoint
daily for 7 days
Method of measurement
respiration in one minute
4
Description
food tolerance
Timepoint
daily for 7 days
Method of measurement
physician judgment
Secondary outcomes
empty
Intervention groups
1
Description
Standard treatment + sublingual drop containing squalene, 15 drops for the first day of admission and then 10 drops a day for 4 days
Category
Treatment - Drugs
2
Description
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