Effect of Camostate mesylate on clinical improvement and outcome of patients with Coronavirus (COVID-19)-induced pneumonia will be studied.
Design
A clinical trial with a control group, with parallel groups, simple-randomly assigned to intervention and control groups, Phase 3, consisted of 40 patients
Settings and conduct
This study will be performed in Imam Reza Hospital, Tabriz, Iran. 40 patients will be divided into two groups (20 in each group) by simple randomization. The routine lab data, CT scan of lungs, hospitalization period, need to intubation and mortality rate will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with moderate to severe 2019-nCoV-infected patients; 18 Years to 80 Years; both genders and positive PCR will be involved in this study. Non-inclusion criteria: Patients with elevated liver enzymes (3 times); who are participating in other drug clinical trials; active pulmonary tuberculosis; definite bacterial and fungal infections; pregnant or lactating women.
Intervention groups
Intervention group: Patients in the Camostate mesylate group will be prescribed Camostate mesylate 200 mg three times daily for three days and standard regimen for COVID-19. Control group: patients in the control group will be prescribed the standard regimen for COVID-19.
Main outcome variables
The change of pneumonia severity on CT scan images; hospitalization period; mortality rate
General information
Reason for update
Acronym
ComCov
IRCT registration information
IRCT registration number:IRCT20200317046797N1
Registration date:2020-04-03, 1399/01/15
Registration timing:prospective
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Sepideh Zununi Vahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
sepide.zununi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Camostate mesylate on clinical improvement and outcome of Coronavirus (COVID-19)-induced pneumonia
Public title
Effect of Camostate mesylate on the outcome of Coronavirus (COVID-19)-induced pneumonia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe 2019-nCoV-infected patients
Being at the age of 18 to 80 years
Patients or authorized family members volunteered to participate in this study and signed informed consent.
Both genders
pulmonary involvement in CT scan
PCR positive
Exclusion criteria:
Patient with elevated liver enzymes 3 time the upper limit of normal
Patients who are participating in other drug clinical trials
Patients with active pulmonary tuberculosis
Patients with definite bacterial and fungal infections
Pregnant or lactating women
Patient with active thrombotic event
Age
From 18 years old to 80 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
Simple randomization sequence will be generated with a computer from 1 to 40. The computer will divide the digits between the two groups. According to the sequence of admission, the patients will be allocated to the control or the Camostate mesylate groups regarding the sequence of computerized random list.
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.TBZMED.REC.1398.1312
Health conditions studied
1
Description of health condition studied
Coronavirus (COVID-19)-induced pneumonia
ICD-10 code
J12.89
ICD-10 code description
Other viral pneumonia
2
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Lung symptoms
Timepoint
At baseline (before intervention) and after drug administration
Method of measurement
Lung CT scan
2
Description
Hospitalization period
Timepoint
At baseline and discharge time
Method of measurement
Counting the day
3
Description
Mortality rate
Timepoint
At baseline and discharge time
Method of measurement
Observation
4
Description
Need for intubation
Timepoint
At baseline and discharge time
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty patients with Coronavirus (COVID-19)-induced pneumonia in addition to standard regimen of covid-19, will receive Camostate mesylate tablets for 3 days (200 mg three times daily).
Category
Treatment - Drugs
2
Description
Control group: they will receive standard regimen for COVID-19 patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Dr Khalil Ansarin
Street address
Imam Reza Hospital; Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 2073
Email
dr.ansarin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Third Floor; Central Building # 2; Tabriz University of Medical Sciences; Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Khalil Ansarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital; Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 2898
Email
dr.ansarin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Ardalan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
ardalan34@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sepideh Zununi Vahed
Position
Assistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Tabriz University of Medical Sciences; Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 9331
Email
sepide.zununi@gmail.com
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
Considering the crisis conditions of the Pandemic Corona and the increasing number of patients, our top priorities are the patients management and the search for effective medication (s).