The effect of naproxen on the healing process of COVID-19 patients in Abadan
Design
This randomized clinical trial study has parallel intervention and control groups, phase 3, sample size of 40, without blinding. Samples are selected according to inclusion and exclusion criteria through convenient sampling and assigned to intervention and control groups by simple random method.
Settings and conduct
The study is being conducted at Ayatollah Taleghani Hospital in Abadan. People in the intervention group also use naproxen along with Standard protocol national drugs. But in the control group only antiviral and antibacterial drugs are used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 15 years of age, chest CT scan confirming covid-19, clinical symptoms of covid-19, confirmation of covid-19 by an infectious disease physician, having informed consent to participate in the intervention. Exclusion criteria: Has a history of gastrointestinal bleeding, pregnant or lactating women, taking losartan or captopril
Intervention groups
In the intervention group, patients also take naproxen in addition to taking Standard protocol national drugs. In the control group, patients only take Standard protocol national drugs.
Main outcome variables
The healing process of patients with COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046850N3
Registration date:2020-03-30, 1399/01/11
Registration timing:registered_while_recruiting
Last update:2020-03-30, 1399/01/11
Update count:2
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Sara Mobarak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
s.mobarak@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of naproxen on the healing process of patients with COVID-19
Public title
The effect of naproxen on the healing process of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a chest CT scan to confirm Covid 19
Having Clinical symptoms of covid 19 including fever, muscle pain, shortness of breath, dry cough, sore throat, runny nose
Confirmation of covid19 by an infectious disease physician
Having consent to participate in the intervention
Exclusion criteria:
Pregnant and lactating women
Those taking losartan and captopril.
Those with a history of intestinal ulcers or gastrointestinal bleeding.
Children under 14 years
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is 6 unit block randomization. Unit of randomization is individual. Tools for randomization is a computer software. Sealed envelopes were used for allocation concealment
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 Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.ABADANUMS.REC.1398.115
Health conditions studied
1
Description of health condition studied
corona virus disease
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
fever
Timepoint
At the time of positive test and 14 days later
Method of measurement
Using oral thermometer
2
Description
Cough
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination
3
Description
Chills
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination
4
Description
Night sweats
Timepoint
At the time of positive test and 14 days later
Method of measurement
Clinical observation and examination
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: National standard protocol drug recipients (Hydroxychloroquine sulfate 200mg tablets two single dose (Tehran Drug) or Chloroquine phosphate 150 mg two single dose tablets (Pars), kaletra tablets (Lupinavir / ritonavir) (Indian Ritocom) 2 hour tablet 50/200)
Category
Treatment - Drugs
2
Description
Group 2: National standard protocol drug recipients (Hydroxychloroquine sulfate 200mg tablets two single dose (Tehran Drug) or Chloroquine phosphate 150 mg two single dose tablets (Pars), kaletra tablets (Lupinavir / ritonavir) (Indian Ritocom) 2 hour tablet 50/200) + naproxen 500mg Warm every 12 hours (manufactured by Pars Daroo Tehran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Sara Mobarak
Street address
Ayatollah Taleghani Hospital. University Blvd. Nurse Square. Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan city
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Sara Mobarak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Abadan School of Medical Sciences, Beginning of the street 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154
Phone
+98 61 5338 4004
Email
s.mobarak@abadanums.ac.ir
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