Determining the results of treatment strategy including oseltamivir, naproxen, hydroxychloroquine in outpatients with Covid 19
Design
Patients were treated with a treatment strategy after a certain diagnosis, based on clinical evidence and inflammatory examinations that did not have symptoms. Patients were divided into two groups in parallel; a group received only Hydroxychloroquine and Naproxen, and the second group, in addition to the two drugs, received Oseltamivir. both groups were treated to prevent the digestive effects of Pantoprazole therapeutic strategy by 20 mg twice, the symptoms and procedure of treatment of patient patients were followed.
Settings and conduct
Patients with Covid 19 referred to a specialized clinic for lung and office who receive oxygen saturation percentage less than 90% by receiving oxygen by reservation bag, provided the inclusion criteria, in two groups of 50 people as a control and intervention, The intervention group was treated with naproxen, hydroxychloroquine and oseltamivir and the second group were treated with naproxen hydroxychloroquine.
Participants/Inclusion and exclusion criteria
inclusion:
Patients with Covid 19 coincide with disease confirmation
Positive PCR test
Bilateral lung involvement
Having symptoms of the disease
Minimum elementary literacy
The patient should not participate in another trial.
Oxygen saturation level below 90
; exclusion:
Lack of patient cooperation
Intervention groups
Intervention group: the three drugs Naproxen 500 mg twice daily, Hydroxychloroquine 200 mg twice daily, and Oseltamivir 75 mg twice daily for 5 days 5 days
Control group: from two drugs Naproxen 500 mg twice, Hydroxychloroquine 200 mg twice a day
Main outcome variables
Status of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201202049566N1
Registration date:2021-01-22, 1399/11/03
Registration timing:retrospective
Last update:2021-01-22, 1399/11/03
Update count:0
Registration date
2021-01-22, 1399/11/03
Registrant information
Name
akram asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3912 2000
Email address
aasgharii@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-03-09, 1398/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment strategy Included : hydroxychloroquine ,naproxen and oseltamivir for outpatient patients with Covid 19
Public title
treatment strategy Included: hydroxychloroquine, naproxen, and oseltamivir for outpatient patients with Covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid 19 with concurrent disease confirmation
Positive PCR test
Bilateral lung involvement
Having symptoms of the disease
Oxygen saturation level: below 90
does not participate in another trial
least basic literacy
Exclusion criteria:
Lack of cooperation
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics Committee of Qom University of Medical Sciences
Street address
blv.beheshti
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.MUQ.REC.1399.209
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
Having symptoms indicative of cough, shortness of breath, fever
Timepoint
Daily - 14 days after treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient is quarantined at home for two weeks and uses two drugs, naproxen 500 mg twice daily, hydroxychloroquine 200 mg twice daily, and oseltamivir 75 mg twice daily for 5 days.
Category
Treatment - Drugs
2
Description
Control group: The patient is quarantined at home for two weeks and uses two drugs, naproxen 500 mg twice daily, hydroxychloroquine 200 mg twice daily for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Seyed Hasan Adeli
Street address
Beheshti Blv
City
Qom
Province
Ghoum
Postal code
37719964797
Phone
+98 25 3612 2000
Email
adeli@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Safashahr
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 61 22000
Email
ehsansharifipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Akram Asghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Beheshti hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3912 2000
Fax
Email
aasgharii@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Akram Asghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
behehsti blv
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
aasgharii@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
akram asghari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
beheshti blv
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
aasgharii@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document