COVID-19Phase 3NCT05122234
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19
A Phase 3 study testing Injection of secretome - mesenchymal stem cell and Standard treatment of Covid-19 in people with COVID-19, run by Universitas Indonesia at 4 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Injection of secretome - mesenchymal stem cell and Standard treatment of Covid-19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesIndonesia
- Study dates
- 10 Aug 2020to 14 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Rumah Sakit Universitas Indonesia
Depok, West Java
RSUP Fatmawati
Jakarta, DKI Jakarta
RSUP Persahabatan
Jakarta, DKI Jakarta
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta
About this study
Official title: Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
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
- COVID-19
- Being tested
- Injection of secretome - mesenchymal stem cell, Placebo, Standard treatment of Covid-19
- Keywords
- Severe Covid-19, secretome, mesenchymal stem cell, cytokine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of secretome - mesenchymal stem cellBiological
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.
PlaceboOther
Normal saline
Standard treatment of Covid-19Drug
Standard treatment of Covid-19 based on national protocol.
| Study group | Role | What they receive |
|---|---|---|
| Secretome - mesenchymal stem cell group (n = 20) | Experimental | This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy Receives: Biological: Injection of secretome - mesenchymal stem cell; Drug: Standard treatment of Covid-19 |
| Control ( n= 20) | Placebo comparator | This group will be given placebo and COVID-19 standard therapy Receives: Other: Placebo; Drug: Standard treatment of Covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (before intervention), day 7, day 14
Secondary outcomes (5)
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.
Measured: before and after intervention (maximum 14 days after intervention)
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.
Measured: before and after intervention (maximum 14 days after intervention)
Assessment of photo thorax
Photo thorax will assess before and after intervention
Measured: before and after intervention (maximum 14 days after intervention)
Assessment of RT-PCR conversion
RT-PCR conversion will assess before and after intervention
Measured: before and after intervention (maximum 14 days after intervention)
Mortality rate
Measured: maximum 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start10 Aug 2020
- Primary completion30 Jul 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murdani abdullah, Universitas Indonesia
- Investigators
- Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE, Principal investigator, Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122234
- Sponsor's protocol ID
- 54/FI/P-KCOVID-19.2B3/IX/2020
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
- ClinicalTrials.gov ID
- NCT05122234
- Acronym / sponsor ID
- 54/FI/P-KCOVID-19.2B3/IX/2020
- Conditions
- COVID-19
- Keywords
- Severe Covid-19, secretome, mesenchymal stem cell, cytokine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secretome - mesenchymal stem cell group (n = 20) | Experimental | Biological: Injection of secretome - mesenchymal stem cell, Drug: Standard treatment of Covid-19This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy |
| Control ( n= 20) | Placebo comparator | Other: Placebo, Drug: Standard treatment of Covid-19This group will be given placebo and COVID-19 standard therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of secretome - mesenchymal stem cellSecretome 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. | Biological | Secretome - mesenchymal stem cell group (n = 20) |
| PlaceboNormal saline | Other | Control ( n= 20) |
| Standard treatment of Covid-19Standard treatment of Covid-19 based on national protocol. | Drug | Control ( n= 20), Secretome - mesenchymal stem cell group (n = 20) |
Primary outcome
Assessment of inflamation marker levels
Time frame: Day 0 (before intervention), day 7, day 14
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.
5 secondary outcomes
Assessment of clinical outcome
Time frame: before and after intervention (maximum 14 days after intervention)
Assessment of laboratory routine
Time frame: before and after intervention (maximum 14 days after intervention)
Assessment of photo thorax
Time frame: before and after intervention (maximum 14 days after intervention)
Assessment of RT-PCR conversion
Time frame: before and after intervention (maximum 14 days after intervention)
Mortality rate
Time frame: maximum 14 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE principal investigator
Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injection of secretome - mesenchymal stem cell and Standard treatment of Covid-19 in people with COVID-19, run by Universitas Indonesia at 4 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of inflamation marker levels (time frame: Day 0 (before intervention), day 7, day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.