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Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients (DW-MSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535856
Recruitment Status : Completed
First Posted : September 2, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Ina-Respond

Tracking Information
First Submitted Date  ICMJE August 28, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE November 14, 2020
Actual Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Incidence of TEAE* in Treatment group [ Time Frame: 28 days ]
Incidence of TEAE* in Treatment group * TEAE: Treatment-Emergent Adverse Event All adverse reactions will be organized according to System Organ Class (SOC) and Preferred Term (PT) using MedDRA (Medical Dictionary for Regulatory Activities), and the incidence of treatment-emergent adverse events will be summarized for the coded adverse reactions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Survival rate [ Time Frame: until Day 14 and Day 28 ]
    Survival rate is defined as the rate of subjects surviving until Day 14 and Day 28, and the number and rate of surviving subjects for each administration group is given.
  • Duration of hospitalization [ Time Frame: 28 days ]
    Duration of hospitalization is defined as the number of days in the hospital until Day 28, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.
  • Clinical improvement Ordinal scale [ Time Frame: from baseline to Day 14 and Day 28 ]
    Clinical improvement measured by Ordinal scale change for clinical improvement from baseline to Day 14 and 28
  • Clinical improvement National EWS [ Time Frame: from baseline to Day 7, 14 and Day 28 ]
    Clinical improvement measured by National EWS (National Early Warning Score) change from baseline to Day 7, 14, 28. EWS Points, Risk and Interpretation as follows: 0~4: Low clinical risk; interpretation= Ward-based response 3~4 : Low~medium clinical risk; interpretation= Urgent ward-based response 5~6: Medium clinical risk; interpretation= Key threshold for urgent response
  • Clinical improvement Oxygenation index [ Time Frame: Day 1, 3, 7, 10, 14, 28 ]
    Clinical improvement measured by Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28)
  • Clinical improvement Lung involvement change [ Time Frame: Day 7, 14, 28 ]
    Clinical improvement measured by Lung involvement change by Imaging from baseline (Day 7, 14, 28)
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for WBC
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for Lymphocytes
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for ESR
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for CRP
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for Fibrinogen
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline for IL-6, TNF-α, IL-1β, IF-γ (Day 7, 14, 28)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • Survival rate [ Time Frame: 28 days ]
    Survival rate is defined as the rate of subjects surviving until Day 14 and Day 28, and the number and rate of surviving subjects for each administration group is given.
  • Duration of hospitalization [ Time Frame: 28 days ]
    Duration of hospitalization is defined as the number of days in the hospital until Day 28, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.
  • Clinical improvement Ordinal scale [ Time Frame: 28 days ]
    Clinical improvement measured by Ordinal scale change for clinical improvement from baseline to Day 14 and 28
  • Clinical improvement National EWS [ Time Frame: 28 days ]
    Clinical improvement measured by National EWS (National Early Warning Score) change from baseline to Day 7, 14, 28
  • Clinical improvement Oxygenation index [ Time Frame: Day 1, 3, 7, 10, 14, 28 ]
    Clinical improvement measured by Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28)
  • Clinical improvement Lung involvement change [ Time Frame: Day 7, 14, 28 ]
    Clinical improvement measured by Lung involvement change by Imaging from baseline (Day 7, 14, 28)
  • Clinical improvement Inflammation markers change [ Time Frame: Day 7, 14, 28 ]
    Inflammation markers change from baseline (WBC, Lymphocytes, ESR, CRP, Fibrinogen, IL-6, TNF-α, IL-1β, IF-γ (Day 7, 14, 28)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients
Official Title  ICMJE Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled
Brief Summary

This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy.

This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration

Detailed Description

Patients with Covid-19 have a mortality rate of about 35 ~ 50% and currently, severe patients caused by the Coronavirus show respiratory distress. To date, the incidence rate has been more than 3 million each year; however, as the increase and globalization of the environmental pollution has been expanded, the number of patients is expected to increase due to acute diseases such as the Middle East Respiratory virus, SARS, and coronavirus.

Since 2015, Daewoong Pharmaceutical intends to use stem cells for product research on rare and intractable diseases including respiratory distress. Stem cells are also called pluripotent cells or truncal cells that can convert to any organ. It is an embryonic stage undifferentiated cell that has stopped differentiating before forming a specific organ whose differentiation has not been determined and has the ability to differentiate into muscle, bone, and internal conformal body organs. There are three types of stem cells: embryonic stem cells, adult stem cells, and induced pluripotent stem cells. Daewoong Pharmaceutical intends to develop cell therapy products using mesenchymal stem cells (MSC).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Double-blind, and Placebo-controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind, To maintain the double-blind of the study, a statistician who do not participate in this study will independently generate randomization code only using the PLAN procedure (Proc Plan procedure) of SAS (ver. 9.4 or higher, SAS Institute, Cary, NC, USA).
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Corona Virus Infection
  • SAR
Intervention  ICMJE
  • Drug: allogeneic mesenchymal stem cell

    Assignment of Administration Group allogeneic mesenchymal stem cell:

    • Low-dose group (5 x 10^7cells)
    • High-dose group (1 x 10^8 cells)
    Other Name: Investigational product
  • Other: Placebo
    Control group (placebo)
Study Arms  ICMJE
  • Experimental: Low-dose group

    Low-dose group (5 x 10^7cells):

    Drug substance and the amount: 2.5 × 107 cells/1 mL/vial, 2 vials for low-dose group

    Intervention: Drug: allogeneic mesenchymal stem cell
  • Experimental: High-dose group

    High-dose group (1 x 10^8 cells):

    Drug substance and the amount: 2.5 × 107 cells/1 mL/vial, 4 vials for High-dose group

    Intervention: Drug: allogeneic mesenchymal stem cell
  • Placebo Comparator: Control group (placebo)

    Control group (placebo):

    No Drug substance: 4 vials for Place group

    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2020)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 14, 2021
Actual Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 19 years or older at the time of screening
  2. Those who have been confirmed COVID-19 infection through PCR test
  3. Patients with mild or moderate COVID-19 who meet National EWS (0~6)
  4. Those who have given written consent and voluntarily decided to participate before the screening procedure after understanding the detailed description of the clinical trial.
  5. Those who are suitable as subjects for this clinical study when judged by physical examination, clinical laboratory test, and other medical examination as stated in the flowchart of protocol.

Exclusion Criteria:

  1. Those who have history of hypersensitivity to the components of the investigational product or the reference product
  2. Those with viral or bacterial pneumonia other than expected indications
  3. Patients receiving organ transplants within 6 months of screening
  4. Patients with a history of pulmonary embolism
  5. Patients who have indications of investigational products as an underlying disease (ex. HIV patients in the clinical study of antiretroviral drugs)
  6. Patients who are pregnant or lactating
  7. Those who are determined by the investigator to be unsuitable for participation in the clinical trial due to other reasons including the results of the clinical laboratory test.
  8. Patients participating in other clinical studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04535856
Other Study ID Numbers  ICMJE DW_DWP710101
U1111-1263-1723 ( Other Identifier: WHO UTN Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ina-Respond
Study Sponsor  ICMJE Ina-Respond
Collaborators  ICMJE
  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
  • Daewoong Pharmaceutical Co. LTD.
Investigators  ICMJE
Study Chair: Dr. Muhammad Karyana, MPH Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia
PRS Account Ina-Respond
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP