Protocol summary
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Study aim
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Determination of safety and efficacy of Sakarya-20 inhalation solution as antiviral therapy in COVID-19 patients
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Design
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This study is a pilot single assignment clinical trial and add-on design study, in which patients receive Sakarya-20 inhalation solution in addition to standard treatment. The patients who refer to the emergency department of Azad University hospitals due to COVID-19 disease were evaluated by a physician in terms of inclusion and non-inclusion criteria and after completing the consent form Letters (by the patient, guardian or guardian) are randomized using the random number method and entered into the project in a treated or controlled grouping.
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Settings and conduct
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The trial is performed in Farhikhtegan Hospital of Azad University based on open single assignment pilot clinical trial. This study is open labeled clinical trial (there is no need for blindness and randomization).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age above 18 years, Having a number of clinical signs of coronary heart disease by a specialist, Confirmation of the disease by diagnostic test PCR-viral load test.
Inclusion criteria:
Age under 18, need to be hospitalized, Consumption of any other pharyngeal inhaler, pregnancy and lactation
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Intervention groups
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Ten patients were enrolled in the study and all patients take Sakarya-20 pharyngeal inhalation solution along with standard treatments. The method of administration is that the patient first inhales 0.5 cc every 8 hours for two days, and from the third to the ninth day 0.5 cc solution once a day.
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Main outcome variables
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Virus clearance
General information
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Reason for update
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Increase the number of patients from 10 to 14, according to the judges
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211003052661N1
Registration date:
2021-10-14, 1400/07/22
Registration timing:
prospective
Last update:
2022-03-07, 1400/12/16
Update count:
1
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Registration date
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2021-10-14, 1400/07/22
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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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2022-02-28, 1400/12/09
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Expected recruitment end date
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2022-04-29, 1401/02/09
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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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Evaluation of safety and antiviral effect of Sakarya-20 inhaled solution containing fuzzy nanoparticles on the recovery of patients with Covid-19
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Public title
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Evaluation of the effect of Sakarya-20 in the treatment of Covid disease - 19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Admission of Covid-19 patients over 18 years of age who are diagnosed based on a number of clinical coronary symptoms (dry cough, fever, headache, sore throat, lymphopenia or thrombocytopenia) by a physician and confirmed by PCR-viral diagnostic test load test (swallowing of the throat and nose) is performed in the laboratory. COVID-19 patients with mild to moderate disease who do not need to be admitted to the coronary ward (no lung involvement or very little involvement confirmed by CT scan) are included in the study if they are satisfied.
Exclusion criteria:
Age under 18,
Lung involvement (need to be hospitalized), malignant tumor and other acute systemic diseases, co-infection with HIV, tuberculosis, history of asthma, asthma-like attacks and respiratory problems, life-threatening comorbidity
Consumption of any other pharyngeal inhaler, pregnancy and lactation
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Age
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From 18 years old
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Gender
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Both
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Phase
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0
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Groups that have been masked
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No information
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Sample size
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Target sample size:
14
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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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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2021-09-28, 1400/07/06
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Ethics committee reference number
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ir.iau.ps.rec.1400.232
Health conditions studied
1
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Description of health condition studied
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COVID-19
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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, virus identified
Primary outcomes
1
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Description
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Virus clearance
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Timepoint
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Before and after intervention
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Method of measurement
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Polymerize chain reaction test using thermocycler
Secondary outcomes
1
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Description
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Percentage of oxygen saturation
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Timepoint
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Before and after the intervention
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Method of measurement
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Oximeter
2
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Description
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clinical symptoms changes
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Timepoint
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Before and after the intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: Patients take Sakarya-20 pharyngeal inhalation solution along with standard treatments. Sakarya-20 contains: a complex of nanoparticles (gold, silver and iron) with a total concentration of 40 ppm soluble in water manufactured by Hayyan pharmaceutical company. The method of administration is that the patient first inhales 0.5 cc every 8 hours for two days, and from the third to the ninth day 0.5 cc solution once a day.
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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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No
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Title of funding source
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Personal
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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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Private
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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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Other
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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is 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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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Part of the data, such as information about the main outcome or the like, can be shared.
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When the data will become available and for how long
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15 days after the publication of the article
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To whom data/document is available
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Specialists and researchers in the field of health and medicine
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Under which criteria data/document could be used
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The use of documents will be allowed by mentioning the source.
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From where data/document is obtainable
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To Dr. Ali Maleki
ali.malaki2775@gmail.com
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What processes are involved for a request to access data/document
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Investigation and verification of the applicant, and the applicant request
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Comments
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