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IRCT20210218050404N2 IRCT 2021-09-16 Fasa University of Medical Sciences Clinical evaluation effects of ZAX.1400.C01 in patients with coronavirus Clinical evaluation of ZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021 2021-09-27 anticipated 60 Complete https://irct.ir/trial/57602 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be performed on patients with coronavirus hospitalized in Vali Asr Hospital in Fasa. the patients data will be record (medication regimen, age and sex, severity of disease and severity of symptoms) by individualize code. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, gender, severity and symptoms, of the disease, and randomly divides one group into group A and one group into group B using the patient. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software, Blinding description: after fulfillment of inclusion criteria the physician will be prescribe A (the drug) or B (placebo) according to the randomized sheet. the prescription will be dispense in the same package. healthcare givers will be unaware about coding dedicated to every patient. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer. 2-3 Incidence of inflammation due to the mechanism of COVID19. Intervention 1: Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days. Intervention 2: Control group: The composition of popcorn corn flour, in the form of capsules, is consumed in two daily doses for a period of 14 days. Yes - There is a plan to make this available What will be shared: Some of the information obtained will be available based on changes in initial outcomes. When: Start of access period 6 months after production and publication of results To whom: People engaged in research in medical universities of the country Conditions: 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 Where to obtain: 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 How to obtain: 1. Contacting the general respondent of the study 2. Sending his formal request to the 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 in accordance with the ethical principles. 5. The total duration of the process is 20 days. Comments:
public Amin Dakhili Ardestani
Ibn Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0996 a.dakhili@fums.ac.ir Fasa University of Medical Sciences scientific Seyyed Amin Kouhpayeh
Ibn Sina Square, Fasa.
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 0996 kouhpayeha@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of COVID-19 disease by laboratory test from the patient's lung sputum Age from 18 to 65 years Patient hemoglobin saturation (SPO2) between 85% and 93% Detection of lung involvement percentage by CT scan 20-30 breaths per minute informed consent by participate in the study 18 years 65 years Both liver and kidney diseases diabetes Pregnancy and lactation anticoagulants administration (aspirin, Plavix, warfarin) hypertension History of allergies to plant products Disagreement of the physician in charge of the patient before randomization Inability of the patient to take oral medication U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days. Control group: The composition of popcorn corn flour, in the form of capsules, is consumed in two daily doses for a period of 14 days. Inflammatory mediators of IL6. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: ELISA test. Mortality. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Duration of hospitalization. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Need oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Equipment used in oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Incidence of Acute respiratory distress syndrome (ARDS). Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Fever. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Cough. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. The patient needs to be hospitalized. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list. Fasa University of Medical Sciences Approved 2021-07-20 Ethics Committee of Fasa University of Medical Sciences Ibn Sina square, Fasa. Fasa Fars Iran (Islamic Republic of)