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

NCT04535856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-01-27

No results posted yet for this study

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

Interventions

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

Placebo

Control group (placebo)

Sponsors & Collaborators

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    collaborator OTHER

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Ina-Respond

    lead OTHER

Principal Investigators

  • Dr. Muhammad Karyana, MPH · Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-14
Primary Completion
2021-01-14
Completion
2021-01-14

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535856 on ClinicalTrials.gov