Evaluation of the effectiveness of gabapentin and montelukast + gabapentin combination compared to dextromethorphan in the improvement of cough in patients with COVID-19 pneumonia
comparison of improving cough in patients with covid-19 between gabapentin, gabapentin+montelukast, and dextromethorphan groups
Design
Open-label randomized controlled clinical trial
Settings and conduct
The research will take place at Isfahan University of Medical Sciences' Al-Zahra Hospital. The medicine described in the previous section will be prescribed to participants. Patients in all three groups will receive standard care based on the doctor's recommendations and prescriptions (infectious disease specialist). Questionnaires will be filled out before the study begins, during the treatment, and at the conclusion.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Covid-19 infection with any severity with the criteria of pulmonary involvement in CT scan of the lung with RT PCR test
2- no intubation
3- Age older than or equal to 18 years
4- BCSS score higher than 2
Exclusion criteria:
1- Intubation (mechanical ventilation),
2- Sensitivity to drugs,
3- Decreased level of consciousness,
4- Intolerance of PO,
5- discharge earlier than 6 days,
6- Chronic and allergic lung disease,
7- Consumption of ACE inhibitors
8- Consumption of SSRIs / SNRIs by patients
Intervention groups
In this study, there will be two intervention groups and a control group, which are described below:
Intervention group 1: Gabapentin 300 mg capsule every 8 hours will be prescribed for at least 6 days
Intervention group 2: Gabapentin 300 mg capsules plus Montglucast 10 mg tablets daily will be prescribed for at least 6 days.
Control group: Dextromethorphan 30 cc syrup will be prescribed every 8 hours for at least 6 days.
Main outcome variables
cough severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N24
Registration date:2022-12-21, 1401/09/30
Registration timing:registered_while_recruiting
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of gabapentin and montelukast + gabapentin combination compared to dextromethorphan in the improvement of cough in patients with COVID-19 pneumonia
Public title
The effect of gabapentin and the combination of gabapentin and montelukast on cough in Covid-19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Infection of Covid-19 with any severity with the criteria of pulmonary involvement in lung CT scan with positive test RT PCR Covid-19
BCSS score higher than 2
Oral intake (PO) tolerance
Exclusion criteria:
mechanical ventilation
Allergy to drugs
Loss of consciousness
discharge earlier than 6 days
Chronic underlying and allergic lung disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
185
Randomization (investigator's opinion)
Randomized
Randomization description
At the arrival of each patient, using a random number table, a random number will be selected for him/her by putting the finger on the table with closed eyes. If even, odd or zero numbers are selected, the patient is entered into dextromethorphan, gabapentin and gabapentin/monteloukast groups, respectively.
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
Isfahan University of Medical Sciences
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.952
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Cough severity
Timepoint
Before and after the intervention
Method of measurement
VAS (Visual analog scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gabapentin 300-mg Capsules , every 8 hours, for 6 days
Category
Treatment - Drugs
2
Description
Intervention group: gabapentin 300-mg Capsules+ montelukast 10-mg, every 8 hours, for 6 days
Category
Treatment - Drugs
3
Description
Control group: dextromethorphan 30-mg cyrup, every 8 hours, for 6 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Rasool Soltani
Street address
Soffeh
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash Dastjerdi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD