Determination of safety and efficacy of Sakarya-20 inhalation solution as antiviral therapy in COVID-19 patients
Design
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.
Settings and conduct
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).
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Virus clearance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211003052661N1
Registration date:2021-10-14, 1400/07/22
Registration timing:prospective
Last update:2021-10-14, 1400/07/22
Update count:1
Registration date
2021-10-14, 1400/07/22
Registrant information
Name
amir hoseyn moghtader mozhdehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3253 4518
Email address
amirtxt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-16, 1400/08/25
Expected recruitment end date
2022-01-15, 1400/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and antiviral effect of Sakarya-20 inhaled solution containing fuzzy nanoparticles on the recovery of patients with Covid-19
Public title
Evaluation of the effect of Sakarya-20 in the treatment of Covid disease - 19
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Azad Univer
Street address
Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
ir.iau.ps.rec.1400.232
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Virus clearance
Timepoint
Before and after intervention
Method of measurement
Polymerize chain reaction test using thermocycler
Secondary outcomes
1
Description
Percentage of oxygen saturation
Timepoint
Before and after the intervention
Method of measurement
Oximeter
2
Description
clinical symptoms changes
Timepoint
Before and after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Hospital 320 beds
Full name of responsible person
Amir Hossein Moghtadar Mozhdehi
Street address
Hesarak, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 4486 9419
Email
OMID7037579@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Personal
Full name of responsible person
ali maleki
Street address
Andisheh Town
City
تهران
Province
Tehran
Postal code
-
Phone
+98 45 3253 4518
Email
omid7037579@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Behbalin
Full name of responsible person
Somayeh Mahmoodi Baram
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Niyayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 9666 1028
Email
info@behbalin.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Hossein Moghtadar Mozhdehi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Infectious diseases
Street address
Azad University, Medical Sciences Branch
City
tehran
Province
Tehran
Postal code
5661984196
Phone
+98 45 3253 4518
Email
amirtxt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
omid moazenzadeh khyavi
Position
University student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Saadi Street
City
meshkin shahr
Province
Ardabil
Postal code
5661984196
Phone
+98 45 3253 4518
Email
omid7037579@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
15 days after the publication of the article
To whom data/document is available
Specialists and researchers in the field of health and medicine
Under which criteria data/document could be used
The use of documents will be allowed by mentioning the source.
From where data/document is obtainable
To Dr. Ali Maleki
ali.malaki2775@gmail.com
What processes are involved for a request to access data/document
Investigation and verification of the applicant, and the applicant request