Protocol summary

Study aim
The main objective is to investigate the safety and efficacy of cell therapy in patients with ARDS caused by Coronavirus pneumonia as an open-labeled randomized clinical trial.
Design
A controlled randomized clinical trial phase 1-2
Settings and conduct
The study will be conducted at Masih Daneshvari Hospital and Shariati Hospital. Participants, outcome assessors, and analyzers are unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years are included in the study with a definitive diagnosis of COVID-19, which subsequently develops acute respiratory distress syndrome (mild or moderate). COVID-19 patients with severe underlying disease or allergies to the cell or its associated compounds are not included in the study.
Intervention groups
The patients allocated randomly to tree groups: 1) Intervention 1, Patients will receive three doses of MSCs. 2) Control, Patients will receive conventional therapy.
Main outcome variables
Safety ; Blood oxygen saturation; Decreased severity of pneumonia; Improvement of the acute respiratory syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200413047063N1
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Masoud Soleimani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4508
Email address
soleimani.masoud@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Placental Mesenchymal Stem cells for treatment of ARDS in Coronavirus infection, Phase 1 and 2 Clinical Trials
Public title
Placental Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 1-2 Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point Pneumonia that is judged by chest radiograph or CT
Exclusion criteria:
Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table.
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 Tehran University of Medical Sciences
Street address
Keshavarz Blvd- Qods , TUMS
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-03-19, 1398/12/29
Ethics committee reference number
IR.TUMS.VCR.REC.1399.009

Health conditions studied

1

Description of health condition studied
Acute Respiratory Distress Syndrome of COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Adverse events assesment
Timepoint
At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention
Method of measurement
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

2

Description
Blood oxygen saturation
Timepoint
At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention
Method of measurement
Evaluation of Pneumonia Improvement

Secondary outcomes

1

Description
Biomarkers concentrations in plasma
Timepoint
At baseline, 7, 14, 28 days after the first intervention
Method of measurement
Biochemical examination

2

Description
Respiratory efficacy
Timepoint
From baseline to day 7
Method of measurement
Evaluated by the increase in PaO2/FiO2 ratio

3

Description
Intensive care unit-free days
Timepoint
Up to day 8
Method of measurement
Number of day

4

Description
Change in clinical symptoms
Timepoint
At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention
Method of measurement
Evaluation of Pneumonia Improvement

Intervention groups

1

Description
Intervention group:Intervention group: The intervention group 1, Patients will receive three doses of MSCs. Two doses of 100×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0 and day 2 and day 4.
Category
Treatment - Other

2

Description
Control group:Patients will receive conventional therapy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mohammad Alian Nejad
Street address
Shariati Hospital., Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Shariatihosp@tums.ac.ir

2

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Mohammad Reza Hashemian
Street address
Masih Daneshvari Hospital., Darabad Avenue., Shahid Bahonar Avenue
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
smrhashemian@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Execution of Imam Khomeini's Order
Full name of responsible person
Mohammad Mokhber
Street address
Khaled Eslambuli Ave., 17 alley
City
Tehran
Province
Tehran
Postal code
1411533123
Phone
+98 21 8872 5923
Email
info@ setad.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Execution of Imam Khomeini's Order
Proportion provided by this source
40
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
Other

2

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Reza Malekzadeh
Street address
No 21, Besat Street., Western Fatimid Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
dr.reza.malekzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
20
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

3

Sponsor
Name of organization / entity
Oghaf Organization and charity
Full name of responsible person
Sayed Mahdi Khamooshi
Street address
Nofel Loshato St
City
Tehran
Province
Tehran
Postal code
۱۱۴۱۱۵۳۳۱۶
Phone
+98 21 6897 0000
Email
info@oghaf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oghaf Organization and charity
Proportion provided by this source
40
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
Other

4

Sponsor
Name of organization / entity
Opal Parsian Company
Full name of responsible person
Mohamad Azimi
Street address
No. 12, 29 Ave, Alvand st.,
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۵۳۳۱۱۲
Phone
+98 21 8608 4871
Email
info@amencapital.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Opal Parsian Company
Proportion provided by this source
40
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoud Soleimani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Jalal - al- Ahmad-Chamran High way
City
Tehran
Province
Tehran
Postal code
1415533122
Phone
+98 21 8288 0000
Email
soleim_m@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Vasei
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pathology
Street address
Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mvasei@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoud Soleimani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Jalal- al- Ahmad - Chamran highway
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۳۳۱۲۲
Phone
+98 21 8288 0000
Email
soleim_m@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified IPD can be shared
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers and clinicians
Under which criteria data/document could be used
Planning of similar studies in other academic centers
From where data/document is obtainable
e-Mail
What processes are involved for a request to access data/document
1-2 months after request
Comments
Loading...