Assessment the changes in serum IL-1beta, IL-6, IL-8, IL-10, IL-12, TNF-alpha and TGF-beta after using red light on the skin of COVID-19 patients with pneumonia
Design
Randomized controlled trial with two parallel single-blinded groups of intervention and control each containing 21 participants who will be simply randomized. Patients with even number codes will get photobiomodulation therapy but patients will odd number codes will not. Photobiomodulation technique and its anti-inflammatory effect will be compared among the groups with COVID-19 pneumonia. Before and 3 days after using photobiomodulation, serum level of some inflammatory factors will be measured and compared. This study is at phase 2 of research.
Settings and conduct
Setting: Internal ward of Masih Daneshvari Hospital in Tehran.
Blinding method: Non of the participants know whether the device is off or on disregarding their group of participation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Pneumonia; Age>15 years; Consent to participation.
Non-inclusion criteria:
Intubation; Death or discharge; Dermal hypersensitivity; Psoriasis; Local inflammation at the site of using device
Intervention groups
Intervention group: Patients with COVID-19 pneumonia who get photobiomodulation.
Control group: Patients with COVID-19 pneumonia who will use the photobiomodulation turned-off device at the same locations of body.
Comparison of serum inflammatory mediators levels in patients affected by COVID-19 with and without photobiomodulation (PBM)
Public title
Photobiomodulation anti-inflammatory effect in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 Pneumonia
Written consent
Older than 15 years
Exclusion criteria:
Intubated patients
Skin hypersensitivities or its history
Psoriasis
Inflammation of the site of PBM implementation
Age
From 15 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Every patient is given a code at the first step of hospitalization. We use the last digit of the code which is odds or even to randomize the patients. This will be simple randomization for each person separately.
Blinding (investigator's opinion)
Single blinded
Blinding description
We will use turned-on device for the participants who are in the intervention group while the control group will use the turned-off device.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital
Street address
Masih Daneshvari hospital, Darabad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.131
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Interleukin-6
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
2
Description
IL-1-beta
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
3
Description
IL-8
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
4
Description
IL-10
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
5
Description
IL-12
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
6
Description
TNF-alpha
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
7
Description
TGF-beta
Timepoint
Immediately before intervention, 12, 24, 48, 72 hours after intervention
Method of measurement
ELISA immunologic kit (produced by R&D company)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Photobiomodulation with red light on patients' chest , back and neck for 3 days each day for 15 minutes. The device named "Neolys" manufactured by "Life+" company in France.
Category
Treatment - Devices
2
Description
Control group: The device is used for the intervention body location every day for 3 days each for 15 minutes but the device will not be turned-on.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Mehran Marashian
Street address
Masih Daneshvari hospital; Darabad avenue; Bahonar street
City
Tehran
Province
Tehran
Postal code
1995657485
Phone
+98 21 2712 2604
Email
mehranmarashian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Research department
Street address
Masih Daneshvari hospital; Darabad; Bahonar street
City
Tehran
Province
Tehran
Postal code
1996758465
Phone
+98 21 2712 2604
Email
mehranmarashian@gmail.com
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
Mehran Marashian
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Masih Daneshvari hospital; Darabad; Bahonar street
City
Tehran
Province
Tehran
Postal code
Tehran
Phone
+98 21 2712 2604
Email
mehranmarashian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Eslaminejad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari hospital; Darabad; Bahonar street
City
Tehran
Province
Tehran
Postal code
Tehran
Phone
+98 21 2712 2604
Email
mehranmarashian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehran Marashian
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Masih Daneshvari hospital; Darabad; Bahonar street
City
Tehran
Province
Tehran
Postal code
Tehran
Phone
+98 21 2712 2604
Fax
+98 21 2610 9647
Email
mehranmarashian@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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data set will be very hardly shared if necessary and in specific condition.
When the data will become available and for how long
Immediately after publishing all the planned articles.
To whom data/document is available
Related researchers who necessarily need the data will be gave them.
Under which criteria data/document could be used
Research ethics and research rights have to be considered in this regard.
From where data/document is obtainable
The affiliations of the authors would be available when the articles published.
What processes are involved for a request to access data/document
The corresponding author would be available by email and will explain the prerequisites and time to give the data.