Evaluation of the role of naproxen as adjunctive therapy with standard therapies and its efficacy in the early improvement and reduced mortality rate of COVID-19 patients
Evaluation of the role of naproxen as adjunctive therapy with standard therapies and its efficacy in the early improvement and reduced mortality rate of COVID-19 patients
Design
In the blocking technique of simple randomization, blocks will be made in the form of quadruples in [ABAB] mode and the Patients are divided into two equal groups of intervention and control.
Settings and conduct
At the beginning (day zero) and the end of the treatment period (day 10), both groups of patients will be examined using radiological imaging and viral load determination in terms of clinical symptoms. The mortality rate and recovery time will also be recorded.
To perform the virus-time PCR test, a pharyngeal swab will be taken using a swab and the virus transport medium (VTM) at the beginning of treatment (day zero) and the end (day 10) to perform tests. Molecular (gene extraction, cDNA synthesis and real-time PCR testing) will be used.
Patients will be followed up for 30 to 60 days after starting treatment, and the effects of treatment and mortality will be recorded in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Patients who will be admitted for SARS-CoV-2 infection, Age over 18 years, the patient should be voluntary, the conscious consent form must be completed and signed by the patient or his companion.
Exclusion Criteria; high creatinine and kidney problems, active gastrointestinal ulcers.
Intervention groups
Control group: A group of patients who will be treated according to the standard treatment provided in the latest national guide to COVID-19 disease.
Intervention group: A group of patients who will also receive naproxen 500 mg tablets 3 times a day in addition to the standard treatment.
Main outcome variables
The aim of this study is investigation in the length of recovery period after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200410047009N1
Registration date:2020-04-26, 1399/02/07
Registration timing:registered_while_recruiting
Last update:2020-04-26, 1399/02/07
Update count:0
Registration date
2020-04-26, 1399/02/07
Registrant information
Name
Maryam Esghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3014
Email address
esghaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the role of naproxen as adjunctive therapy with standard therapies and its efficacy in the early improvement and reduced mortality rate of COVID-19 patients
Public title
The effect of Naproxen in recovery and reducing mortality in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose SARS-CoV-2 infection has been confirmed using PCR
Age over 18 years
The conscious consent form must be completed and signed by the patient or his companion
The patient should participate in the research voluntarily
Exclusion criteria:
High creatinine and kidney problems
In gastrointestinal ulcers
Other conditions of contraindications to the use of Naproxen
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
101
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two equal groups of intervention and control by simple randomization and ABAB quadruple blocking method.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.IUMS.REC.1399.001
Health conditions studied
1
Description of health condition studied
covid-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Recovery in COVID-19 patients
Timepoint
At the beginning (day zero) and the end of the treatment period (day 10)
Method of measurement
Examination of clinical signs
2
Description
mortality rate in COVID-19 patients
Timepoint
At the end of treatment period
Method of measurement
The percentage of mortality rate in the study population
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of COVID-19 patients who will receive 500 mg Naproxen tablets 3 times a day for 10 days orally, in addition to the standard treatment provided in the latest national guide which the control group receives.
Category
Treatment - Drugs
2
Description
Control group: A group of patients will be treated according to the standard treatment provided in the latest national COVID-19 guide:Two-drug regimen: Oseltamivirwith hydroxychloroquine / chloroquine- Three-Phase Diet: Oseltamivir with Hydroxychloroquine / Chloroquine and Lopinavir / RitonavirFour-Phase Diet:Oseltamivir with Hydroxychloroquine / Chloroquine and Lopinavir / Ritonavir and Ribavirin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated with Iran University of Medical Sciences
Full name of responsible person
Maryam Esghaei
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8770 3014
Email
esghaei.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Esghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,
City
Tehran
Province
Tehran
Postal code
14665354
Phone
+98 21 8670 3014
Email
esghaei.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Esghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
ran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
تهران، بزرگراه همت ج
Phone
+98 21 8670 3014
Email
esghaei.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Esghaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
ran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 3014
Email
esghaei.m@iums.ac.ir
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
Not applicable
Title and more details about the data/document
Information on the results of the use of naproxen
When the data will become available and for how long
The first access, 6 months after publishing the results
To whom data/document is available
For researchers working in academic institutions
Under which criteria data/document could be used
Physicians are allowed to use data to treat patients.
From where data/document is obtainable
Maryam Esghaei
What processes are involved for a request to access data/document
Receive the documents by sending an e-mail to Dr Maryam Esghaei.