Determining the effect of novel formulation (Noscovid) on clinical and pulmonary manifestations of COVID-19 patients
Design
This study is double blinded clinical trial in phase 2 which will be carried out on 125 COVID-19 patients into two groups (hospitalized & non-hospitalized patients).
Both groups randomly divided into two groups. Control group and treatment group which received of medicine (Noscapine 25 mg).
Clinical signs of patient including body temperature, cough, Shortness of breath, respiratory rate, and o saturation will be recorded before and after treatment. Diagnostic imaging will be carried out before and after treatment. Radiological and clinical Findings will be assessed by pulmonologist and othe relevant clinicians.
Settings and conduct
This clinical trial will be carried out on 125 COVID-19 patients into two groups (hospitalized & non-hospitalized patients) in Velayat hospital of Qazvin.
Patient will received medicine based on defined protocol.
In this study patients, nurse , intern and researcher don't know which group of patients will use the medicine.
Physician and clinicians team know about the drug and group who use the drug.
Participants/Inclusion and exclusion criteria
COVID-19 patient with Positive PCR test & CT finding
Intervention groups
This clinical trial will be carried out on 125 COVID-19 patients into two groups (hospitalized & non-hospitalized patients).
Both groups divided into two groups. Control group and treatment group which received of medicine (Noscapine 25 mg)
Main outcome variables
Body temperature- Pain- cough- Shortness of breath- respiratory rate- O2 saturation-
General information
Reason for update
Acronym
NOSCOVID
IRCT registration information
IRCT registration number:IRCT20160625028622N1
Registration date:2020-03-22, 1399/01/03
Registration timing:registered_while_recruiting
Last update:2020-03-22, 1399/01/03
Update count:0
Registration date
2020-03-22, 1399/01/03
Registrant information
Name
Ehsan Aali
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
e.aali@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-04-17, 1399/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of NOSCOVID on pulmonary & other clinical manifestations of COVID-19 patients
Public title
The effect of Noscapine on clinical and pulmonary manifestations of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR test for Coronavirus (SARS-COV2)
CT Scan finding
Exclusion criteria:
Patient who use warfarin
Patient who ACEI (captopril. enalapril,... )
Age
From 2 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
125
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, nurse , supervisor and researcher don't know which group of patients will use the medicine.
Physician and clinicians team know about the drug and group who use the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Qazvin universe of medical scienced
Street address
Beheshti
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2641-06-08, 2020/03/18
Ethics committee reference number
IR.QUMS.REC.1398.417
Health conditions studied
1
Description of health condition studied
Novel Cronavirus Disease (COVID-19)
ICD-10 code
COVID-19
ICD-10 code description
بیماری ویروسی کرونا
Primary outcomes
1
Description
cough
Timepoint
Daily
Method of measurement
Clinical finding
2
Description
O2 Saturation
Timepoint
daily
Method of measurement
Pulse Oximeter
3
Description
Radiographic features Findings
Timepoint
Before/After
Method of measurement
Radiography- CT SCAN
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment group which received Noscapine mg, tds
Category
Treatment - Drugs
2
Description
Control group: Group receiving Placebo with no API
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital qazvin
Full name of responsible person
Dr Mohammad Ali Zohal
Street address
22 Bahman
City
Qazvin
Province
Qazvin
Postal code
028-33790610
Phone
+98 28 3379 0610
Email
mzohal@qums.ac.ir
Web page address
http://hosvelayat.qums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
دکتر امام جمعه
Street address
Shahid beheshti
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
Web page address
http://vcr.qums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ehsan Aali
Position
Assistant Professor of Pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
en.aali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ehsan Aali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
e.aali@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ehsan Aali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
Email
en.aali@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of novel formulation c on clinical and pulmonary manifestations of COVID-19 patients
When the data will become available and for how long
end of June
To whom data/document is available
healthcare professional- Professors
Under which criteria data/document could be used
Official request from organization
From where data/document is obtainable
Department of pharmacology- Qazvin university of medical sciences
What processes are involved for a request to access data/document
Request to Vice-Chancellor for Research and Technology Affairs