Assessing the effect of genetical nanocomposit drug with cell immunity level on human coronavirus (COVID-19)
Design
Clinical trial with control group, with parallel groups, non-randomly assigned to intervention and control groups, Phase 1-2, 30 patients
Settings and conduct
This clinical trial is performed in Shahid Sadoughi hospital of Isfahan. In this way, four experimental groups including one control and 3 intervention groups with Corona contamination, in three levels of primary and secondary and advanced are classified. The drug is applied each 12 hours to patients in the form of nasal application, there are 2 days of treatment and 1 day off. Total length of the course is 8 to 10 days based on the results of the patients remedy
Participants/Inclusion and exclusion criteria
Only individuals with symptoms of Corona disease are among the participants. People with a critical physical condition cannot participate in the test due to acute disease.
Intervention groups
Groups are infected patients with Corona virus that their viral contamination status are in three primary, secondary and advanced levels. All patients use prescription medications in addition to new drug, except the control group that only use routin drugs.
Main outcome variables
The effect of drug on recovery of patients with Corona virus; stop fever; clear lungs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200321046828N1
Registration date:2020-03-26, 1399/01/07
Registration timing:registered_while_recruiting
Last update:2020-03-26, 1399/01/07
Update count:0
Registration date
2020-03-26, 1399/01/07
Registrant information
Name
Mahdi Khozaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 3139
Email address
mahdi_khozaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-22, 1399/01/03
Expected recruitment end date
2020-03-29, 1399/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of genetical nanocomposit drug with cell imunity level on human coronavirus (COVID-19)
Public title
Remedy of human coroviruse infection with genetic nanocomposit drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infection with coronavirus
Exclusion criteria:
People with multiple problems
Cancer
Critical physical condition
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Azad university of Isfahan
Street address
Arghavanieh St
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.001
Health conditions studied
1
Description of health condition studied
Infectious disease and respiratory of the Corona virus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection
Primary outcomes
1
Description
The treatment of patients with corona infection. In healthy subjects the CT image of the lungs signs an improvement of the corona contamination.
Timepoint
At the beginning of the test, positive people are determined based on who tests and then the severity of disease is classified through fever and CT-pulmonary image. Then, after 8-10, the initial cases including fever and CT lungs, as well as general individuals, were analyzed.
Method of measurement
CT scan
2
Description
Fever
Timepoint
At the beginning of the test, then 8 - 10 days after taking the new drug and ensuring efficacy
Method of measurement
Thermometers
Secondary outcomes
1
Description
General condition of people and vitality after treatment
Timepoint
After 8-12 days after the start of treatment
Method of measurement
Examination and explanation
Intervention groups
1
Description
Control group 1: Positive people with corona virus infection after laboratory tests are classified according to expert diagnosis and based on the patient's symptoms and history as well as laboratory results with primary infection in the first control group. This spectrum of patients is treated by the Ministry of Health's pharmacological and medical regimen, which is monitored by relevant specialists.
Category
Treatment - Drugs
2
Description
Intervention group 1: In this group, patients will be diagnosed with corona virus primary infection after the corona virus infection is confirmed. The symptoms and level of virus infection is categorized with specialist. For this group the same dose of 2 puffs is used every 12 hours. An estimate of 400 ug / ml is considered for each dose of drug. The drug is given 8 days every two days for the patient to have optimal efficacy. The chemical formula is reserved for the RNA Biotechnology company, but according to the ethics committee, no harm can be expected to consumers. The new drug has FDA-approved components.
Category
Treatment - Drugs
3
Description
Intervention group 2: . Once the corona virus infection is confirmed positive and the clinical symptoms are diagnosed according to the specialist's diagnosis, the secondary level of corona virus infection is defined. The application of drugs for this group is same as group 1. the same dose of 2 puffs is used every 12 hours. An estimate of 400 ug / ml is considered for each dose of drug. The period time for treatment of the drug is 8 days and the drug application is for every two days and a resting day for the patient to be optimal for effectiveness. The chemical formula for the RNA Biotechnology company is protected, but according to the ethics committee, there is no compensation for consumer users. The new drug has FDA approved components.
Category
Treatment - Drugs
4
Description
Intervention group3: Once the corona virus infection is confirmed positive and the clinical symptoms are diagnosed according to the specialist's diagnosis, the advanced level of corona virus infection is defined. this group like other groups, the same dose of 2 puffs is used every 12 hours. An estimate of 400 ug / ml is considered for each dose of drug period time for treatment of the drug is 8 days and the drug application is for every two days and a resting day for the patient to be optimal for effectiveness. The chemical formula for the RNA Biotechnology company is protected, but according to the ethics committee, there is no compensation for consumer users. The new drug has FDA approved components.
Category
Treatment - Drugs
5
Description
Control group II: Positive people with corona virus infection after laboratory tests are classified according to expert diagnosis and based on the patient's symptoms and history as well as laboratory results in secondary level infection control group. In this group, the disease progresses to a more advanced level and the infection reaches a wider stage. This range of patients is treated by the Ministry of Health's pharmacological regimen, which is monitored by relevant specialists.
Category
Treatment - Drugs
6
Description
Control group III: Positive people with corona virus infection after laboratory tests are classified as advanced infection according to expert diagnosis and based on the patient's symptoms and history as well as laboratory results. In this group, the development of highly advanced disease and infection has reached a broad stage, in which patients are treated by the Ministry of Health's medicinal and medical regimen, which is monitored by relevant specialists.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Sadoghi general hospital
Full name of responsible person
Mr Eng Montazeri
Street address
Bozorgmehr St
City
Isfahan
Province
Isfehan
Postal code
81548
Phone
+98 31 3291 2027
Email
sadoghihospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
RNA biotechnology, Science base company
Full name of responsible person
Dr Mahdi Khozaei
Street address
Bozorgmehr St
City
Isfahan
Province
Isfehan
Postal code
81586
Phone
+98 31 3267 3139
Email
info@rnabiotech.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
RNA biotechnology, Science base company
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
Islamic Azad University
Full name of responsible person
Dr Mahdi Khozaei
Position
Asscociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Bozorgmehr St
City
Isfahan
Province
Isfehan
Postal code
81586
Phone
+98 31 3267 3139
Email
mahdi_khozaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ِDr Mahdi Khozaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Bozorgmehr St
City
Isfahan
Province
Isfehan
Postal code
81586
Phone
+98 31 3267 3139
Email
mahdi_khozaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mahdi Khozaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Bozorgmehr St
City
Isfahan
Province
Isfehan
Postal code
81586
Phone
+98 31 3267 3139
Email
mahdi_khozaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available