Evaluation of anti-inflammatory effect of ZAX.1399.C03 on airways inflammation in patients with coronavirus in home care

Determining the effect of ZAX.1399.C03 on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients in home care

The triple blind clinical trial, two treatment groups and parallel control, The stage will be over 60 patients. For randomization, we will use the method of permutation blocks with a number of 6 blocks using Random allocation software.

Patients with COVID19 in home care are divided into groups A and B. The anti-inflammatory effects of ZAX.1399.C03 evaluated. The study will be blinded at the level of outcome assessor and statistical analyst of results. Location: Fasa University of Medical Sciences

Admission requirements: 1. Definitive diagnosis of COVID-19 2. Age over 18 years 3. Both sexes (male and female) 4. Having informed and written consent to participate in the study 5. No history of any allergies 6. Do not take anticoagulants 7. Not getting pregnant and breastfeeding 8. No diabetes in the person Conditions for not entering the study: 1. Disagreement of the physician in charge of the patient 2. History of any allergies 3. History of heart and kidney disease 4. Patient disagreement 5. History of high blood pressure

Divide patients into two similar groups A and B. The treatment group contains capsules containing ZAX.1399.C03 and the placebo group contains capsules containing fried corn flour. By introducing the plan and justifying the patient, written consent is received.

1. Serum levels of inflammatory mediators IL6 2. Degree of hemoglobin saturation (SPO2) in the normal range

1. In order to protect the intellectual property of the project, the name of the studied plant product has been removed and the phrase ZAX.1399.C03 has been replaced. 2. The English translation sections have been revised from a grammatical point of view and "minor" changes have been made. 3. The main outcome variable is described in the abstract of serum IL6 level and the degree of hemoglobin saturation of the blood.

This study is performed on patients referred to health centers and infectious disease specialists in the present study. For home care patients, the admit code along with the relevant information (medication regimen, age and sex, severity of the disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly divides one group into group A and one group into group B using the patient code numbers. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software.

For blinding, the study of the drug and placebo with the names A and B in the same package are prescribed by the doctor to the patient. (Capsules according to The principles of pharmacy are created by a pharmacist.) A patient-level study, outcome evaluator, and statistical analyst of the results will be blind. Only the manufacturer of the drug can decode the contents of each capsule based on the original retained form of the randomization results The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not be aware of the coding. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer.

Some of the information obtained will be available based on changes in initial outcomes.

Start of access period 6 months after production and publication of results

People engaged in research in medical universities of the country

The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if information is used

Dr. Seyyed Amin Kouhpayeh Email address: kouhpayeha@gmail.com Contact number: 09177087247 Address: Department of Pharmacology, Fasa University of Medical Sciences and Health Services, Fasa, Iran. Email Address: Amindakhiliardestani@yahoo.com Contact number: 09228584505 Address: Fasa University, Fasa University of Medical Sciences and Health Services, Fasa, Iran.

1. Contact the scientific or general respondent of the study 2. Sending their official request to the respondent 3. Apply to the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process from the time of receiving the request is 20 days.