Protocol summary
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Study aim
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Evaluation of safety and efficacy of mesenchymal stem cells in patients with COVID19
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 20 patients. Software was used for randomization.
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Settings and conduct
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Stem cell injection to patients with acute pulmonary insufficiency with COVID19 (these cells are approximately 2x 106 cells per kilogram (based on IBW) will be injected IV through the patient 3 times at 3-day intervals (0, 3, 6). )
Shariati Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
1- Age more than 18 years and less than 65 years
2- Clinical symptoms, including:
30≤ PR, SO2≤ 93% at rest or persistent hypoxia
3- Respiratory failure requires a ventilator
4- Chest x-ray: in Chest have multilobar infiltrates% <50
Exclusion criteria
1. Patient dissatisfaction
2. Pregnant patient
3. Age under 18 years and over 65 years
4. Patient with known active malignancy
5. Septic shock
6. Organ failure
7. Enter another study
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Intervention groups
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Treatment Group: Patients with coronavirus 19 who are transplanted with mesenchymal stem cells at a rate of two million per kilogram of body weight (based on IBW) through peripheral blood on days 0, 3, and 6.
Control group: Participants receive routine treatment and placebo (based on IBW) intravenously on days 0, 3, and 6.
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Main outcome variables
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Clinical response; O2 saturation; inflammation cytokines. Il-6 & Il-10
General information
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Reason for update
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Request to change the phone number in the Registrant information section to 989127249532
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190717044241N3
Registration date:
2020-12-31, 1399/10/11
Registration timing:
registered_while_recruiting
Last update:
2021-01-02, 1399/10/13
Update count:
1
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Registration date
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2020-12-31, 1399/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-12-21, 1399/10/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Cell therapy in patients with COVID-19 using mesenchymal stem cells: Phase 2 clinical trial
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Public title
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Cell therapy in patients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Persistent hypoxemia despite receiving less than 93% Saturation oxygen
Respiratory failure requires a Ventilator
Chest has multilobar infiltrates
Exclusion criteria:
Patient dissatisfaction
Pregnant patient
Age under 18 years and over 65 years
Patient with known active malignancy
Shock
Organ failure
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Age
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From 17 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization was used for achieving equal sample sizes in each group. For example, in intervention (I)/control (C) comparison, the process involved recruiting participants in short blocks and ensuring that half of the participants within each block were allocated to the ‘‘I’’ group and the other half to the ‘‘C’’ group. Within each block, however, the order of patients was random. We considered size 4 blocks. If I/C is represented by I/C methods, there would be 6 different ways in which 4 patients can be split evenly between 2 methods.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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There are the same cell bags for infusion during the study. Cleanroom staff, DSMB, and data statisticians just aware of their contents.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-01, 1399/09/11
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.823
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Clinical response
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Timepoint
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28 days-From the time of cell injection until the 28th day
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Method of measurement
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clinical observation by Infectious Diseases Specialist
2
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Description
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O2 saturation
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Timepoint
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Since the injection of the cell; 0,3,6 days.
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Method of measurement
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ventilator
Secondary outcomes
1
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Description
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inflammation cytokines. Il-6 & Il-10
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Timepoint
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On days 0,3,6,14 - from the time of cell injection
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Method of measurement
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Assay by the Elisa
2
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Description
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CD4 and CD8 markers
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Timepoint
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On days 0,3,6,14 - from the time of cell injection
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Method of measurement
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Flow Cytometry
3
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Description
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Evaluation of lung function
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Timepoint
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On days 0,14 - from the time of cell injection
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Method of measurement
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CT scan of the lungs
Intervention groups
1
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Description
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Intervention group: Patients with coronavirus 19 who undergo mesenchymal stem cell transplantation at a rate of 2 million per kilogram body weight (based on IBW) through peripheral blood (IV)on days 0, 3, and 6.
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Category
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Treatment - Other
2
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Description
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Control group: Participants with COVID19 receiving routine and placebo treatment (based on IBW) intravenously on days 0, 3, and 6.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Barakat Pharmaceutical Group
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Proportion provided by this source
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80
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no additional data.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available