Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
NCT05122234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-11-16
Summary
This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.
Conditions
Interventions
- BIOLOGICAL
-
Injection of secretome - mesenchymal stem cell
Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.
- OTHER
-
Placebo
Normal saline
- DRUG
-
Standard treatment of Covid-19
Standard treatment of Covid-19 based on national protocol.
Sponsors & Collaborators
-
Indonesia University
lead OTHER
Principal Investigators
-
Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE · Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-10
- Primary Completion
- 2021-07-30
- Completion
- 2021-11-14
Countries
- Indonesia
Study Locations
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