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Covid19Phase 1DW-MSCNCT04535856

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

A Phase 1 study testing allogeneic mesenchymal stem cell in people with Covid19 and Corona Virus Infection, run by Ina-Respond at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Covid19, Corona Virus Infection, SAR
What is being tested?
allogeneic mesenchymal stem cell
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteIndonesia
Study dates
14 Nov 2020to 14 Jan 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 19 years or older at the time of screening
  • Those who have been confirmed COVID-19 infection through PCR test
  • Patients with mild or moderate COVID-19 who meet National EWS (0~6)
  • Those who have given written consent and voluntarily decided to participate before the screening procedure after understanding the detailed description of the clinical trial.
  • 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.

Who cannot join

  • Those who have history of hypersensitivity to the components of the investigational product or the reference product
  • Those with viral or bacterial pneumonia other than expected indications
  • Patients receiving organ transplants within 6 months of screening
  • Patients with a history of pulmonary embolism
  • Patients who have indications of investigational products as an underlying disease (ex. HIV patients in the clinical study of antiretroviral drugs)
  • Patients who are pregnant or lactating
  • 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.
  • Patients participating in other clinical studies

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital

    Makassar, 90245

Other trials in Indonesia

About this study

Official title: Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled

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

Read the 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).

Being tested
allogeneic mesenchymal stem cell, Placebo
Keywords
Infectious Disease, covid-19, allogeneic mesenchymal stem cell
Medical subject headings
COVID-19, Coronavirus Infections, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • allogeneic mesenchymal stem cellDrug

    Also called Investigational product

    Assignment of Administration Group allogeneic mesenchymal stem cell:

    • Low-dose group (5 x 10^7cells)
    • High-dose group (1 x 10^8 cells)

  • PlaceboOther

    Control group (placebo)

Study groups in NCT04535856
Study groupRoleWhat they receive
Low-dose groupExperimentalLow-dose group (5 x 10^7cells): Drug substance and the amount: 2.5 × 107 cells/1 mL/vial, 2 vials for low-dose group
Receives: Drug: allogeneic mesenchymal stem cell
High-dose groupExperimentalHigh-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
Receives: Drug: allogeneic mesenchymal stem cell
Control group (placebo)Placebo comparatorControl group (placebo): No Drug substance: 4 vials for Place group
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of TEAE* in Treatment group

    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.

    Measured: 28 days

Secondary outcomes (12)

  1. Survival rate

    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.

    Measured: until Day 14 and Day 28

  2. Duration of hospitalization

    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.

    Measured: 28 days

  3. Clinical improvement Ordinal scale

    Clinical improvement measured by Ordinal scale change for clinical improvement from baseline to Day 14 and 28

    Measured: from baseline to Day 14 and Day 28

  4. Clinical improvement National EWS

    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

    Measured: from baseline to Day 7, 14 and Day 28

  5. Clinical improvement Oxygenation index

    Clinical improvement measured by Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28)

    Measured: Day 1, 3, 7, 10, 14, 28

  6. Clinical improvement Lung involvement change

    Clinical improvement measured by Lung involvement change by Imaging from baseline (Day 7, 14, 28)

    Measured: Day 7, 14, 28

  7. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for WBC

    Measured: Day 7, 14, 28

  8. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for Lymphocytes

    Measured: Day 7, 14, 28

  9. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for ESR

    Measured: Day 7, 14, 28

  10. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for CRP

    Measured: Day 7, 14, 28

  11. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for Fibrinogen

    Measured: Day 7, 14, 28

  12. Clinical improvement Inflammation markers change

    Inflammation markers change from baseline for IL-6, TNF-α, IL-1β, IF-γ (Day 7, 14, 28)

    Measured: Day 7, 14, 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start14 Nov 2020
  3. Primary completion14 Jan 2021
  4. Study completion14 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-blind, and Placebo-controlled Clinical Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535856
Sponsor's protocol ID
DW_DWP710101
Other IDs
U1111-1263-1723
Acronym
DW-MSC
Status last verified
Jan 2021
First submitted
28 Aug 2020
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karyana M, Djaharuddin I, Rif'ati L, Arif M, Choi MK, Angginy N, Yoon A, Han J, Josh F, Arlinda D, Narulita A, Muchtar F, Bakri RA, Irmansyah S. Safety of DW-MSC infusion in patients with low clinical risk COVID-19 infection: a randomized, double-blind, placebo-controlled trial. Stem Cell Res Ther. 2022 Apr 1;13(1):134. doi: 10.1186/s13287-022-02812-4.

    PubMed 35365239

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing allogeneic mesenchymal stem cell in people with Covid19 and Corona Virus Infection, run by Ina-Respond at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of TEAE* in Treatment group (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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