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

NCT04535856 | Completed Phase 1

• 2 other identifiers: DW_DWP710101U1111-1263-1723
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; Corona Virus Infection; SAR

Keywords

Infectious Disease; covid-19; allogeneic mesenchymal stem cell

Outcome Measures

Primary Outcomes (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.

  28 days

Secondary Outcomes (12)

• Survival rate

  until Day 14 and Day 28

• Duration of hospitalization

  28 days

• Clinical improvement Ordinal scale

  from baseline to Day 14 and Day 28

• Clinical improvement National EWS

  from baseline to Day 7, 14 and Day 28

• Clinical improvement Oxygenation index

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

Study Arms (3)

Low-dose group

EXPERIMENTAL

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

Drug: allogeneic mesenchymal stem cell

High-dose group

EXPERIMENTAL

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

Drug: allogeneic mesenchymal stem cell

Control group (placebo)

PLACEBO COMPARATOR

Control group (placebo): No Drug substance: 4 vials for Place group

Other: Placebo

Interventions

allogeneic mesenchymal stem cell DRUG

Assignment of Administration Group allogeneic mesenchymal stem cell: * Low-dose group (5 x 10\^7cells) * High-dose group (1 x 10\^8 cells)

Also known as: Investigational product

High-dose group; Low-dose group

Placebo OTHER

Control group (placebo)

Control group (placebo)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ina-Respond: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

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

Makassar, 90245, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 35365239 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Muhammad Karyana, MPH

  Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, and Placebo-controlled Clinical Trial

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: November 14, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)