Back to resultsMesenchymal Stem Cell Secretome In Severe Cases of COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Injection of secretome - mesenchymal stem cell
Placebo
Standard treatment of Covid-19
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Severe Covid-19, secretome, mesenchymal stem cell, cytokine
Eligibility Criteria
Inclusion Criteria:
- All individuals aged 18 to 65 years
- It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
- Categorized as a severe case of COVID-19 patient
- Agree to participate and sign the informed consent
Exclusion Criteria:
- History of allergy to penicillin, streptomycin, and amphotericin-B
- Have any cancer conditions
- Active in other intervention studies
- Have had other intervention studies in the last 3 months
Sites / Locations
- RSUPN Dr. Cipto Mangunkusumo
- RSUP Fatmawati
- RSUP Persahabatan
- Rumah Sakit Universitas Indonesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Secretome - mesenchymal stem cell group (n = 20)
Control ( n= 20)
Arm Description
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
This group will be given placebo and COVID-19 standard therapy
Outcomes
Primary Outcome Measures
Assessment of inflamation marker levels
The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.
Secondary Outcome Measures
Assessment of clinical outcome
Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.
Assessment of laboratory routine
Laboratory routine assessed in this study is NLR, lymphocyte count, thrombocytes count, CRP, blood gas analysis, bilirubin, albumin, SGOT, SGPT, ureum/creatinin, glomerular filtration rate (GFR), electrolyte, myoglobin, troponin, D-dimer.
Assessment of photo thorax
Photo thorax will assess before and after intervention
Assessment of RT-PCR conversion
RT-PCR conversion will assess before and after intervention
Mortality rate
Full Information
NCT ID
NCT05122234
First Posted
November 13, 2021
Last Updated
November 13, 2021
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT05122234
Brief Title
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
Official Title
Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
November 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Severe Covid-19, secretome, mesenchymal stem cell, cytokine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Secretome - mesenchymal stem cell group (n = 20)
Arm Type
Experimental
Arm Description
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Arm Title
Control ( n= 20)
Arm Type
Placebo Comparator
Arm Description
This group will be given placebo and COVID-19 standard therapy
Intervention Type
Biological
Intervention Name(s)
Injection of secretome - mesenchymal stem cell
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
Standard treatment of Covid-19
Intervention Description
Standard treatment of Covid-19 based on national protocol.
Primary Outcome Measure Information:
Title
Assessment of inflamation marker levels
Description
The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.
Time Frame
Day 0 (before intervention), day 7, day 14
Secondary Outcome Measure Information:
Title
Assessment of clinical outcome
Description
Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.
Time Frame
before and after intervention (maximum 14 days after intervention)
Title
Assessment of laboratory routine
Description
Laboratory routine assessed in this study is NLR, lymphocyte count, thrombocytes count, CRP, blood gas analysis, bilirubin, albumin, SGOT, SGPT, ureum/creatinin, glomerular filtration rate (GFR), electrolyte, myoglobin, troponin, D-dimer.
Time Frame
before and after intervention (maximum 14 days after intervention)
Title
Assessment of photo thorax
Description
Photo thorax will assess before and after intervention
Time Frame
before and after intervention (maximum 14 days after intervention)
Title
Assessment of RT-PCR conversion
Description
RT-PCR conversion will assess before and after intervention
Time Frame
before and after intervention (maximum 14 days after intervention)
Title
Mortality rate
Time Frame
maximum 14 days after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All individuals aged 18 to 65 years
It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
Categorized as a severe case of COVID-19 patient
Agree to participate and sign the informed consent
Exclusion Criteria:
History of allergy to penicillin, streptomycin, and amphotericin-B
Have any cancer conditions
Active in other intervention studies
Have had other intervention studies in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE
Organizational Affiliation
Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSUPN Dr. Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
RSUP Fatmawati
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
RSUP Persahabatan
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
Rumah Sakit Universitas Indonesia
City
Depok
State/Province
Jawa Barat
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
We'll reach out to this number within 24 hrs