To study the effect of nimesulide in the treatment of COVID-19 pneumonia.
Design
Uncontrolled Longitudinal study, single-center, comprising 60 patients with COVID-19 infection
Settings and conduct
All the patients will receive nimesulide 100 mg twice daily and sucralfate suspension 10 ml twice daily for five days. Patients who have a raised CRP will be prescribed azithromycin 250 mg twice daily for five days. Those patients who have a raised D-dimers test (greater than 500) will be given enoxaparin in a dose of 40 mg subQ once daily for five days.
All patients will have a baseline spO2 measured and a chest radiograph done that will be repeated after 5 days.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Participant is willing and able to give informed consent for participation in the study and agrees with the study protocol
• Adults ≥ 12 years
• Not previously diagnosed with COVID-19 infection or treated.
Exclusion Criteria:
• Participant is allergic to any of the study groups.
• Participants with a contraindication to any of the drugs including:
o Active bleeding
o Recent Myocardial infarction (last three months)
o Peptic ulcer disease
• Already taking an NSAID or Nimesulide.
• Inability to be followed up for the trial period
Intervention groups
Nimesulide is an anti-inflammatory drug that will be added to the treatment regimen of all patients with COVID-19 infection who are enrolled in the study and followed after five days.
Main outcome variables
The outcome will be measured in terms of a percent change in oxygen saturation, hospitalization, or death.
General information
Reason for update
Acronym
NICI
IRCT registration information
IRCT registration number:IRCT20200723048178N1
Registration date:2020-07-28, 1399/05/07
Registration timing:registered_while_recruiting
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Ahmed Farhan
Name of organization / entity
Pakistan Institute of Medical Sciences
Country
Pakistan
Phone
+92 51 9261592
Email address
drfarhan992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-28, 1399/05/07
Expected recruitment end date
2020-09-27, 1399/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of Nimesulide in the treatment of COVID-19 infection
Public title
nimesulide in COVID-19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The participant is willing and able to give informed consent for participation in the study and agrees with the study protocol
Not previously diagnosed with COVID-19 infection or treated.
Adults ≥ 12 years
Exclusion criteria:
The participant is allergic to any of the study group
Inability to be followed up for the trial period
Already taking an NSAID or Nimesulide
Participants with a contraindication to any of the drugs including Active bleeding, Recent Myocardial infarction (last three months), or Peptic ulcer disease
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Uncontrolled longitudinal study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shaheed Zulfiqar Ali Medical University
Street address
G-8/3
City
Islamabad
Postal code
46000
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
No.F.1-1//2015/ERB/SZABMU/605
Health conditions studied
1
Description of health condition studied
COVID-19 infection
ICD-10 code
U07.2
ICD-10 code description
COVID-19
Primary outcomes
1
Description
percent change in the oxygen saturation, hospitalization, or death.
Timepoint
1 week
Method of measurement
Oxygen saturation is measured via pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nimesulide 100 mg twice daily for five days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Safiya Medical Center
Full name of responsible person
Ahmed Farhan
Street address
Ali Akbar house, G-8 Markaz, Islamabad
City
Islamabad
Postal code
46000
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed zulfiqar ali medical university
Full name of responsible person
Dr. Ahmed Farhan
Street address
G-8/2 Islamabad Capital Territory
City
Islamabad
Postal code
46000
Phone
+92 51 2331590
Email
emedz.net@gmail.com
Web page address
https://www.emedz.net
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ahmed farhan
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shaheed Zulfiqar Ali Mdical University
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
House # 116, Jhelum Road, G-8/1 Islamabad
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://www.emedz.net
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Zulfiqar Ali Medical University
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
House # 116, Jhelum Road, G-8/1
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://www.emedz.net
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Zulfiqar Ali Medical University
Full name of responsible person
Ahmed Farhan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
House # 116, Jhelum road, G-8/1
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 2331590
Email
drfarhan992@gmail.com
Web page address
https://www.emedz.net
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcome
When the data will become available and for how long
Data will be available for six months after its collection
To whom data/document is available
Healthcare workers
Under which criteria data/document could be used
Data may be requested via email
From where data/document is obtainable
individuals can ask for it via the personal email of the investigator
What processes are involved for a request to access data/document
Data may be available within a week after the request.