Protocol summary
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Study aim
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Evaluation the effect of ZAX.1400.C01 on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients hospitalized
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Design
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A triple-blind clinical trial, two treatment groups and a parallel control group will be performed on 60 patients. For randomization, we will use the method of permutation blocks with a number of 6 blocks using Random allocation software.
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Settings and conduct
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Patients with COVID19 admitted to Vali-e-Asr Hospital in Fasa are divided into two groups A and B. The anti-inflammatory effects of ZAX.1400.C01will be evaluated. The study will be blinded at the level of outcome assessor, pathologist and statistical analyst of results. Location: Fasa University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1. Definitive diagnosis of COVID-19 2. Age between 18 to 65 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. No use Anticoagulants 7. Non-pregnancy and lactation 8. Absence of 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 dissatisfaction 5. History blood pressure
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Intervention groups
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Divide patients into two similar groups A and B. The treatment group capsules containing ZAX.1400.C01 and the placebo group capsules containing popcorn flour, twice a day. By introducing the plan and justifying the patient, written consent is received.
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Main outcome variables
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Duration of hospitalization
General information
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Reason for update
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1. Considering the defined goals for third generation universities, based on the applicability of research in medical sciences, solving a specific problem as a result of research and preserving the intellectual property of ideas and products
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210218050404N2
Registration date:
2021-09-16, 1400/06/25
Registration timing:
prospective
Last update:
2021-10-10, 1400/07/18
Update count:
1
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Registration date
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2021-09-16, 1400/06/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-27, 1400/07/05
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Expected recruitment end date
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2021-10-27, 1400/08/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical evaluation of ZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021
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Public title
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Clinical evaluation effects of ZAX.1400.C01 in patients with coronavirus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-07-20, 1400/04/29
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Ethics committee reference number
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IR.FUMS.REC.1400.043
Health conditions studied
1
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Description of health condition studied
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Incidence of inflammation due to the mechanism of COVID19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Inflammatory mediators of IL6
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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ELISA test
2
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Description
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mortality
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
3
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Description
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Duration of hospitalization
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
4
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Description
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Need oxygen therapy
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
5
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Description
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Equipment used in oxygen therapy
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
6
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Description
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Incidence of Acute respiratory distress syndrome (ARDS)
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
7
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Description
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fever
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
8
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Description
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cough
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
Secondary outcomes
1
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Description
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The patient needs to be hospitalized
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Timepoint
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Days zero, seven and fourteen after start of the intervention
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Method of measurement
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clinical check list
Intervention groups
1
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Description
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Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Fasa University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Some of the information obtained will be available based on changes in initial outcomes.
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When the data will become available and for how long
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Start of access period 6 months after production and publication of results
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To whom data/document is available
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People engaged in research in medical universities of the country
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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.
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Comments
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