Determining the therapeutic effect of noscapine on cough in patients with COVID-19
Design
A controlled, parallel groups, randomized, double blinded and phase 3 clinical trial on 100 patients
Settings and conduct
The study is a double-blind randomized clinical trial. A total of 100 patients with mild COVID-19 referred to the corona clinic of Masih Daneshvari Hospital were randomly divided into two groups of 50 intervention and control.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with cough and positive RT-PCR for COVID-19 who are candidates for receiving outpatient remdesivir and the onset time is less than 5 days are included in the study. Pregnant, lactating, allergic patients to noscapine, morphine or any of the components of the formulation, history of seizures, diarrhea, diabetes and consumption of warfarin, benzodiazepines, opioid agonists and cough medicines are excluded.
Intervention groups
After obtaining informed consent, patients in the intervention group receive a syrup containing noscapine (Noscough®) 20 cc every 6 hours for 5 days. Patients in the control group receive 7 cc diphenhydramine every 8 hours.
Main outcome variables
Response time to treatment; When the cough goes away; Cough intensity; Quality of Life; Blood oxygen level; Shortness of breath
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N31
Registration date:2022-06-18, 1401/03/28
Registration timing:registered_while_recruiting
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-18, 1401/03/28
Expected recruitment end date
2022-12-19, 1401/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of Noscapine on the Treatment of Cough in COVID-19 Outpatients
Public title
Evaluation of the Effects of Noscapine on the Treatment of Patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
Patient with cough and positive RT-PCR for COVID-19 and candidate for outpatient treatment
The onset of illness equal to/less than 5 days
Exclusion criteria:
Pregnancy
Breastfeeding
Allergy to noscapine, morphine or any of the components of the formulation
History of seizure
Diarrhea
Diabetes
Consumption of warfarin, benzodiazepines, opioid agonists
Getting antitussive drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. Twenty five blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to noscapine group and 2 patients will be assigned to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients included to the study are randomized to two groups of drug and control (noscapine syrup and diphenhydramine syrup) by a randomizer (nurse) according to the randomization list taken from www.sealedenvelope.com. The researcher and data analyst only receive the data in code and were not aware of patients' assignments to the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of School of Pharmacy, Nursing, and Midwifery; Shahid Beheshti University of Medic
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Approval date
2021-12-14, 1400/09/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.252
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Time required to respond to treatment
Timepoint
Daily until discharge
Method of measurement
VAS scale
2
Description
Time required to resolve cough
Timepoint
Daily until discharge
Method of measurement
Patient history
3
Description
Intensity of cough
Timepoint
Daily until discharge
Method of measurement
CSS score
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the start of the study and at the end of the study
Method of measurement
CQLQ questionnaire
2
Description
Blood oxygen level
Timepoint
Before the start of the study and at the end of the study
Method of measurement
Pulse oximeter
3
Description
Shortness of breath
Timepoint
Before the start of the study and at the end of the study
Method of measurement
Patient history
Intervention groups
1
Description
Intervention group: Patients receive Noscapine Syrup (Noscough®) 20 cc every 6 hours for 5 days.
Category
Treatment - Drugs
2
Description
Control group: Patients receive 7 cc diphenhydramine every 8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
f_dastan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2227
Email
saahar26@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2712 2227
Email
f_dastan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2227
Email
saahar26@yahoo.com
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
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
Title and more details about the data/document
All potential data can be shared after blinding.
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document
Official letter to the researchers through Email (fzh.dastan@gmail.com)