Evaluation of therapeutic effects of ZAX.1400.C05 on symptomatic treatment and clinical features of patients with coronavirus: a randomized controlled clinical trial

Determining the effect of ZAX.1400.C05 on the course of the disease and symptomatic treatment of COVID-19 patients hospitalized

The double-blind clinical trial, two treatment groups and parallel control will be the third phase on 300 patients. For randomization, we will use the permutation block method using Random allocation software.

Patients with COVID-19 admitted to Vali-e-Asr Hospital in Fasa are divided into six similar groups of 50 people. The therapeutic effects of ZAX.1400.C05 on clinical and laboratory parameters of patients will be evaluated. The study will be blinded at the level of outcome assessor, physician, patient, and statistical analyst. Location: Fasa University of Medical Sciences

Inclusion criteria: Definitive diagnosis of COVID-19 disease by laboratory diagnostic kit from patient sputum 2. The degree of hemoglobin saturation (SPO2) of the patient is between 85% and 93% in patients 3. Diagnosis of lung involvement by CT scan in patients 4. The number of breaths per minute between 25 and 30 in patients Exclusion criteria: 1. History of allergies to plant products 2. Pregnancy and lactation 3. Existence of liver and kidney diseases 4. Inability of the patient to receive oral medication

Divide the patients into six groups of 50 similar A, B, C, D, E, F. One of the codes will be related to the placebo and the rest will be the drug. Capsule treatment groups containing ZAX.1400.C05 and placebo groups of capsules containing popcorn flour, every 12 hours. By introducing the patient's plan and justification, written consent is received.

Duration of hospitalization

This study was performed on patients with coronary artery and hospitalized in Vali-e-Asr Hospital in Fasa. Takes place. For hospitalized patients, the hospital code along with the relevant information (medication regimen, age and sex, severity of disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into a group of 250 people and a group of 50 people based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly using the code numbers A, B, C, D and E will be done. One of the codes will be for the placebo and the rest will be for the drug. For randomization, the permutation block method is done using Random allocation software.

For the blinding of the study, the drug (capsule containing ZAX.1400.C05) and placebo (including capsule of roasted corn flour) are named in the same package and are prescribed to the patient by the doctor. (Capsules are made according to the principles of pharmacy by a pharmacist.) Before prescribing the drug to the patient, the plan is introduced and written consent is received. Study at the patient level, outcome assessor and statistical analyzer of the results will be blinded. 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 know about the codings. The results of the two groups under the headings of groups A, B, C, D and E will be submitted 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

Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services

1. Contacting the general respondent of study 2. Sending his formal request to respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant by the ethical principles. 5. The total duration of the process is 20 days.