Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with COVID-19
Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with Coronavirus
Design
This study is a randomized double-blinded clinical trial with a control group. In this double-blinded study, Patients are aware of participating in the study and receiving the new drug, but the researcher and the participant will be kept blinded to which group will receive the new drug and which group will receive the placebo. In this randomized study, phase 2/3 will be conducted on at least 8 patients with Covid-19. A random number table is used for randomization and participants are assigned to intervention and control groups.
Settings and conduct
This study that will be conducted in Imam Reza hospital of Kermanshah is double-blinded. The researcher and the participants, contributors have no role in the process of randomization and assignment of intervention and control groups. First, mesenchymal stem cells are isolated from the placenta by enzymatic digestion. Then, the presence of special surface markers is studied by flow cytometry, and their ability to differentiate into mesoderm categories such as bone, fat, and cartilage is examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infected patients with Coronavirus; Diagnosis of acute respiratory syndrome according to Berlin criteria; Requires oxygenation or confirmed pneumonia
Exclusion criteria: Liver or kidney SOFA score more than 3
Intervention groups
The intervention group in addition to the usual treatment protocol will receive single-dose exosomes (one billion exosomes per kilogram)by injection twice on two consecutive days. The control group will receive the usual medicine in addition to the placebo (50cc dextrose saline).
Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with COVID-19
Public title
Investigation of the effects of the exosomes on patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infected patients with Corona virus based on CRISPR test (PCR)
Diagnosis of acute respiratory syndrome according to Berlin criteria
Requires oxygenation or confirmed pneumonia by radiologically or CT
Oxygen uptake concentration
Progression of of pulmonary edema more than 50% within 24-48 hours
Mild to moderate pneumonia caused by a new coronavirus
Exclusion criteria:
Serious underlying illness or psychosis
Co-infection with HIV, tuberculosis, influenza virus, adenovirus and other viral respiratory infections
Liver or kidney SOFA score more than 3
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of at least 4. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7 will be assigned to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded study, the researcher and the patient are unaware of who is receiving the new drug. Initially, a code is considered by the nurse for the intervention group and the placebo group. The code of the intervention group is A and the code of the placebo group is B.The new drug and placebo are injected into the serum, which is the same shape and size for both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.kums.rec.1399.807
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Oxygen saturation
Timepoint
2 to 3 days after injection,daily for two weeks
Method of measurement
Using a pulse oximeter
2
Description
Neutrophil to lymphocyte ratio
Timepoint
2 to 3 days after injection,daily for two weeks
Method of measurement
Using a blood test (To determine the percentage of neutrophils and lymphocytes, the optical method or light microscope and Giemsa staining is used)
3
Description
Ferritin
Timepoint
2 to 3 days after injection,daily for two weeks
Method of measurement
Using a blood test and Chemiluminescence immunoassay method
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in addition to the usual treatment will receive single-dose exosomes (one billion exosomes per kilogram) twice on two consecutive days by injection. Regarding the pharmaceutical company, it has not a pharmaceutical company, separation and processing are done in the cell culture laboratory of the Biological Research Center of Kermanshah University of Medical Sciences.
Category
Treatment - Drugs
2
Description
The control group, in addition to the placebo(50cc dextrose saline), will receive the usual medicine (Recigen; 12000000 unit every other day till 5 dosages, Kaletra, sevodak: daily for 5 days, high dose dexamethasone for 7 days with tapering).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Kamran Mansouri
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
kamranmansouri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
kamranmansouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Faizullah Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
fmansoury@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
kamranmansouri@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe