COVIDPhase 1NCT04457609
Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients
A Phase 1 study testing Oseltamivir, Azithromycin and Umbilical Cord Mesenchymal Stem Cells in people with COVID and Pulmonary Infection, run by Universitas Indonesia at 4 sites in Indonesia.
Trial summary
Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID, Pulmonary Infection, Sars-CoV2
- What is being tested?
- Oseltamivir, Azithromycin and Umbilical Cord Mesenchymal Stem Cells
- 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
- Jul 2020to Sep 2020
- Phase
- Phase 1
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-95 years old
- Confirmed for diagnosis of Covid-19 through RT-PCR from nasopharyngeal swab and/or bronchoalveolar lavage for patients under intubation
- Laboratory results showed leukopenia and lymphopenic
- Chest radiography shows pneumonia appearance and/or ground-glass opacity on chest CT-Scan
- Patients/their families are willing to sign the informed consent
Who cannot join
- History of malignancy
- Pregnant, or show positive result on pregnancy test
- Patients was/are currently participating in other clinical trials within the last 3 months
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites, 4 recruiting
- Recruiting
Universitas Indonesia Hospital
Depok, West Java
Dita Aditianingsih, MD, PhD, +622150829292
Dita Aditianingsih, MD, PhD
- Recruiting
Persahabatan General Hospital
Jakarta, DKI Jakarta
Erlina Burhan, MD, PhD, +62214891708, erlina_burhan@yahoo.com
Triya Damayanti, MD, PhD, +62214891708
- Recruiting
Sulianti Saroso Center for Infectious Disease
Jakarta, DKI Jakarta
Pompini A Sitompul, MD, +62216506559
Pompini A Sitompul, MD
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta
Ismail H Dilogo, MD, PhD, +62211500135
Ismail H Dilogo, MD, PhD
About this study
Official title: Application of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy for Critically-Ill COVID-19 Patients
Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%.
The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection.
Read more
Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding.
Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Read the detailed description
This study is a double blind, randomized control trial (RCT). This study will be concluded in 2 months, from May to July 2020, from subject selection to the end of follow up. Research subjects are obtained consecutively from Covid-19 patients who receive care in the intensive care unit (ICU) across four Covid-19 referral hospitals, including Persahabatan Hospital, Sulianti Saroso Center for Infectious Disease, Cipto Mangunkusumo General Hospital, and Universitas Indonesia Hospital, with 10 subjects obtained from each hospital and total 40 subjects for this RCT. Subjects from each hospitals are divided into control and experimental groups. Subject belongs to the control group will receive standardized therapy (consisting of oseltamivir and azithromycin), whereas subjects in the experimental group will receive MSCs infusion, in addition to standardized therapy.
Subject Criteria Inclusion Criteria for MSC Donor from Umbilical Cord:
Umbilical cord is collected from elective caesarean section from a fullterm pregnancies without any complication and free from HIV, Hepatitis B, C, D virus, Cytomegalovirus, Rubella Virus, and free from fungal and bacterial contamination.
Informed consent all of the subjects must be filled and signed up before ruled in this study.
As soon as after delivery, the umbilical cord is collected and processed in sterile specimen 0,9% NaCl at 4oC for 8 hours. The umbilical cord transported to the laboratory and cultured in GMP lab, at Stem Cells Medical Technology Integrated Service Unit Cipto Mangunkusumo Hospital. Cellular viability and proliferation are evaluated after cell characterization test by flow cytometer.
Sterility tests are done three times to ensure cellular sterility. Subjects will receive MSCs through infusion through intravenous for 1 hour, following the administration of diphenhydramine and anticoagulant to prevent clotting.
Following the MSCs administration, monitoring at the patients is carried out every day, whereas laboratory testing for basic parameters (complete blood count, differential count, blood gas analysis, C-reactive protein, SGOT/SGPT (AST/ALT), Ureum/Creatinine, eGFR, electrolyte, procalcitonin, albumin, total bilirubin, D-Dimer, fibrinogen, troponin I and proBNP) are carried out every three days. Cytokine levels are measured before the administration and 7th day after the administration. Chest radiography is carried out every three days.
- Conditions
- COVID, Pulmonary Infection, Sars-CoV2
- Being tested
- Oseltamivir, Azithromycin, Umbilical Cord Mesenchymal Stem Cells
- Keywords
- Covid-19 Pneumonia, SARS-CoV-2, Mesenchymal Stem Cells, Umbilical Cord
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
Current standardized treatment for Covid-19
AzithromycinDrug
Current standardized treatment for Covid-19
Umbilical Cord Mesenchymal Stem CellsBiological
Adjuvant therapy on top of current standardized treatment (Oseltamivir + Azithromycin)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients receive standardized treatment, consisting of Oseltamivir and Azithromycin Receives: Drug: Oseltamivir; Drug: Azithromycin |
| Experiment Group | Experimental | Patients receive intravenous infusion of 1x10^6 unit of umbilical-cord derived mesenchymal stem cells (UC-MSCs)/kgBW in 100 cc of 0.9% NaCl for 1 hour, in addition to standardized treatment Receives: Drug: Oseltamivir; Drug: Azithromycin; Biological: Umbilical Cord Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement: Presence of dyspnea
Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate
Measured: 15 days
Clinical improvement: presence of sputum
Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation
Measured: 15 days
Clinical improvement: fever
Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis
Measured: 15 days
Clinical improvement: ventilation status
Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase
Measured: 15 days
Clinical improvement: blood pressure
Assessing the patients' blood pressure on daily basis
Measured: 15 days
Clinical improvement: heart rate
Assessing the patients' heart rate on daily basis
Measured: 15 days
Clinical improvement: respiratory rate
Assessing the patients' respiratory rate on daily basis
Measured: 15 days
Clinical improvement: oxygen saturation
Assessing the patients' oxygen saturation on daily basis
Measured: 15 days
Secondary outcomes (32)
General laboratory outcome from leukocyte level
Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from lymphocytes level
Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood pH
Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood level of CO2
Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood base excess level
Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood oxygen partial pressure
Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood level of HCO3
Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from blood level of O2 saturation
Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from level of CRP
Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from level of SGOT/SGPT (AST/ALT)
Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from the level of ureum/creatinine level
Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from the level of eGFR
Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from the level of sodium
Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from the level of potassium
Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from the level of chloride
Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Changes in procalcitonin level
Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from albumin level
Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
General laboratory outcome from total bilirubin level
Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Changes in D-Dimer level
Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Changes in fibrinogen level
Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Cardiac changes from troponin level
Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Cardiac changes from NT proBNP level
Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measured: 15 days
Changes in Leukemia Inhibiting Factor
Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of IL-6
Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of IL-10
Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of vascular endothelial growth factor (VEGF)
Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of ferritin
Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of CXCR3
Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of CD4
Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of CD8
Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Changes in level of CD56
Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measured: 7 days
Radiologic Improvement from Chest X-Ray/CT Scan
Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
- Investigators
- Ismail H Dilogo, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457609
- Sponsor's protocol ID
- ISMMSCCOVID19
- Status last verified
- Jul 2020
- First submitted
- 27 May 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy for Critically-Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04457609
- Acronym / sponsor ID
- ISMMSCCOVID19
- Conditions
- COVID, Pulmonary Infection, Sars-CoV2
- Keywords
- Covid-19 Pneumonia, SARS-CoV-2, Mesenchymal Stem Cells, Umbilical Cord
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Jul 2020 (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.
Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%.
The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection.
Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding.
Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Detailed description
This study is a double blind, randomized control trial (RCT). This study will be concluded in 2 months, from May to July 2020, from subject selection to the end of follow up. Research subjects are obtained consecutively from Covid-19 patients who receive care in the intensive care unit (ICU) across four Covid-19 referral hospitals, including Persahabatan Hospital, Sulianti Saroso Center for Infectious Disease, Cipto Mangunkusumo General Hospital, and Universitas Indonesia Hospital, with 10 subjects obtained from each hospital and total 40 subjects for this RCT. Subjects from each hospitals are divided into control and experimental groups. Subject belongs to the control group will receive standardized therapy (consisting of oseltamivir and azithromycin), whereas subjects in the experimental group will receive MSCs infusion, in addition to standardized therapy.
Subject Criteria Inclusion Criteria for MSC Donor from Umbilical Cord:
Umbilical cord is collected from elective caesarean section from a fullterm pregnancies without any complication and free from HIV, Hepatitis B, C, D virus, Cytomegalovirus, Rubella Virus, and free from fungal and bacterial contamination.
Informed consent all of the subjects must be filled and signed up before ruled in this study.
As soon as after delivery, the umbilical cord is collected and processed in sterile specimen 0,9% NaCl at 4oC for 8 hours. The umbilical cord transported to the laboratory and cultured in GMP lab, at Stem Cells Medical Technology Integrated Service Unit Cipto Mangunkusumo Hospital. Cellular viability and proliferation are evaluated after cell characterization test by flow cytometer.
Sterility tests are done three times to ensure cellular sterility. Subjects will receive MSCs through infusion through intravenous for 1 hour, following the administration of diphenhydramine and anticoagulant to prevent clotting.
Following the MSCs administration, monitoring at the patients is carried out every day, whereas laboratory testing for basic parameters (complete blood count, differential count, blood gas analysis, C-reactive protein, SGOT/SGPT (AST/ALT), Ureum/Creatinine, eGFR, electrolyte, procalcitonin, albumin, total bilirubin, D-Dimer, fibrinogen, troponin I and proBNP) are carried out every three days. Cytokine levels are measured before the administration and 7th day after the administration. Chest radiography is carried out every three days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Oseltamivir, Drug: AzithromycinPatients receive standardized treatment, consisting of Oseltamivir and Azithromycin |
| Experiment Group | Experimental | Drug: Oseltamivir, Drug: Azithromycin, Biological: Umbilical Cord Mesenchymal Stem CellsPatients receive intravenous infusion of 1x10^6 unit of umbilical-cord derived mesenchymal stem cells (UC-MSCs)/kgBW in 100 cc of 0.9% NaCl for 1 hour, in addition to standardized treatment |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-95 years old
- Confirmed for diagnosis of Covid-19 through RT-PCR from nasopharyngeal swab and/or bronchoalveolar lavage for patients under intubation
- Laboratory results showed leukopenia and lymphopenic
- Chest radiography shows pneumonia appearance and/or ground-glass opacity on chest CT-Scan
- Patients/their families are willing to sign the informed consent
Key exclusion criteria (3 listed)
- History of malignancy
- Pregnant, or show positive result on pregnancy test
- Patients was/are currently participating in other clinical trials within 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 |
|---|---|---|
| OseltamivirCurrent standardized treatment for Covid-19 | Drug | Control Group, Experiment Group |
| AzithromycinCurrent standardized treatment for Covid-19 | Drug | Control Group, Experiment Group |
| Umbilical Cord Mesenchymal Stem CellsAdjuvant therapy on top of current standardized treatment (Oseltamivir + Azithromycin) | Biological | Experiment Group |
Primary outcome
Clinical improvement: Presence of dyspnea
Time frame: 15 days
Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate
Clinical improvement: presence of sputum
Time frame: 15 days
Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation
Clinical improvement: fever
Time frame: 15 days
Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis
Clinical improvement: ventilation status
Time frame: 15 days
Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase
Clinical improvement: blood pressure
Time frame: 15 days
Assessing the patients' blood pressure on daily basis
Clinical improvement: heart rate
Time frame: 15 days
Assessing the patients' heart rate on daily basis
Clinical improvement: respiratory rate
Time frame: 15 days
Assessing the patients' respiratory rate on daily basis
Clinical improvement: oxygen saturation
Time frame: 15 days
Assessing the patients' oxygen saturation on daily basis
32 secondary outcomes
General laboratory outcome from leukocyte level
Time frame: 15 days
General laboratory outcome from lymphocytes level
Time frame: 15 days
General laboratory outcome from blood pH
Time frame: 15 days
General laboratory outcome from blood level of CO2
Time frame: 15 days
General laboratory outcome from blood base excess level
Time frame: 15 days
General laboratory outcome from blood oxygen partial pressure
Time frame: 15 days
General laboratory outcome from blood level of HCO3
Time frame: 15 days
General laboratory outcome from blood level of O2 saturation
Time frame: 15 days
General laboratory outcome from level of CRP
Time frame: 15 days
General laboratory outcome from level of SGOT/SGPT (AST/ALT)
Time frame: 15 days
General laboratory outcome from the level of ureum/creatinine level
Time frame: 15 days
General laboratory outcome from the level of eGFR
Time frame: 15 days
General laboratory outcome from the level of sodium
Time frame: 15 days
General laboratory outcome from the level of potassium
Time frame: 15 days
General laboratory outcome from the level of chloride
Time frame: 15 days
Changes in procalcitonin level
Time frame: 15 days
General laboratory outcome from albumin level
Time frame: 15 days
General laboratory outcome from total bilirubin level
Time frame: 15 days
Changes in D-Dimer level
Time frame: 15 days
Changes in fibrinogen level
Time frame: 15 days
Cardiac changes from troponin level
Time frame: 15 days
Cardiac changes from NT proBNP level
Time frame: 15 days
Changes in Leukemia Inhibiting Factor
Time frame: 7 days
Changes in level of IL-6
Time frame: 7 days
Changes in level of IL-10
Time frame: 7 days
Changes in level of vascular endothelial growth factor (VEGF)
Time frame: 7 days
Changes in level of ferritin
Time frame: 7 days
Changes in level of CXCR3
Time frame: 7 days
Changes in level of CD4
Time frame: 7 days
Changes in level of CD8
Time frame: 7 days
Changes in level of CD56
Time frame: 7 days
Radiologic Improvement from Chest X-Ray/CT Scan
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Ismail H Dilogo, MD, PhD principal investigator
Universitas Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oseltamivir, Azithromycin and Umbilical Cord Mesenchymal Stem Cells in people with COVID and Pulmonary Infection, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail H Dilogo, MD, PhD (+621500135, ismailortho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement: Presence of dyspnea (time frame: 15 days). The study lists 8 primary outcomes in all. 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 7 Jul 2020.