Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled
Tahapan Penelitian : Initial
Sponsor:
Badan Penelitian Dan Pengembangan Kesehatan (Badan Litbangkes) dan PT Daewoong Infion
Mitra Pelaksana:
INA-RESPOND dan RSUP dr. Wahidin SUdirohusodo
No Registry
INA-QCA4OWA
Tanggal Input Registry : 28-08-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 11-09-2020 |
| Outcome Primer | Incidence of TEAE* in Treatment group * TEAE: Treatment-Emergent Adverse Event |
| Outcome Skunder | Secondary endpoint: 1. Survival rate on Day 7, 14, and 28 2. Duration of hospitalization 3. Clinical improvement measured by: a. Ordinal scale change for clinical improvement from baseline to Day 14 and 28 b. National EWS change from baseline to Day 7, 14, 28 c. Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28) d. Lung involvement change by Imaging from baseline (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) |
| Descriptive Information | |
| Judul Penelitian Popular | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled |
| Judul Penelitian Ilmiah | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled |
| Jenis Penelitian | Interventional |
| Intervensi | 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 107cells of DW-MSC for the low-dose group or 1 x 108cells for the high-dose group after registration. |
| Jumlah Subyek Penelitian | 9 |
| Recruitment Information | |
| Eligibility Criteria | 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 |
| Administrative Information | |
| Nomor Persetujuan Etik | No. LB.02.01/2/KE.443/2020 tertanggal 2 Juli 2020 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | DW_DWP710101 |
| Contact Person | Dr. Muhammad Karyana, M.Kes |