Investigation of the effect of Lactocare® synbiotic on the prevention of COVID-19 infection in the staff of emergency department
Design
Clinical trial with control group and parallel groups, randomized and double blind
Settings and conduct
This clinical trial is conducted on 80 members of the personnel of the emergency department of Imam Reza hospital including physicians and nurses who work where patients infected by COVID-19 are hospitalized. These participants are randomly assigned to two groups of control and treatment. At the beginning of the study, patients are examined by a specialist and take antibody test and their data including their personal and professional information are recorded. Patients and outcome assessors are unaware of the groupings.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being a member of the personnel of the emergency department of Imam Reza hospital; active presence in the wards where patients with COVID-19 are hospitalized.
Exclusion criteria: history of clinical or laboratory diagnosis with COVID-19
Intervention groups
Intervention group: In this group, patients will receive a Lactocare® synbiotic capsule daily for a month. Control group: Patients in this group will receive a capsule as placebo (with the same shape, smell, design and color) containing no probiotic daily for one month.
Main outcome variables
Fever, findings of CT scan and CXR, number of lymphocytes, WBC and infection by COVID-19, cough and sore throat, nausea, vomiting and diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101020004976N6
Registration date:2020-07-18, 1399/04/28
Registration timing:registered_while_recruiting
Last update:2020-07-18, 1399/04/28
Update count:0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-14, 1399/02/25
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Lactocare® synbiotic on the prevention of COVID-19 infection in the staff of emergency department
Public title
The effect of Lactocare® synbiotic on the prevention of COVID-19 infection in the staff of emergency department
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being a member of the personnel (including physicians and nurses) of the emergency department of Imam Reza hospital
Active presence in the wards where patients with COVID-19 are hospitalized
Exclusion criteria:
History of clinical or laboratory diagnosis with COVID-19
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the grouping. Patients in the control group receive placebo drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Mashhad university of Medical Sciences
Before treatment, during treatment if symptoms appear and at the end of treatment
Method of measurement
PCR and antibody tests
6
Description
Cough and sore throat
Timepoint
Before, during and after treatment
Method of measurement
Clinical observations
7
Description
Nausea, vomiting and diarrhea
Timepoint
Before, during and after treatment
Method of measurement
Clinical observations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients will receive a Lactocare® synbiotice capsule daily for a month.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive a capsule as placebo (with the same shape, smell, design and color) containing no probiotic daily for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Hamid Ahanchian
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
ahanchianh@mums.acir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ِDr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
34591357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ghaem hospital, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2469
Fax
+98 51 3844 8014
Email
ahanchianh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ghaem hospital, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2469
Fax
Email
ahanchianh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ghaem hospital, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3801 2469
Fax
Email
ahanchianh@mums.ac.ir
Web page address
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
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
Comments
After sending a request email to the corresponding author, data will be sent in 1 month.