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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secretome - mesenchymal stem cell group (n = 20) | Experimental | This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy |
|
| Control ( n= 20) | Placebo Comparator | This group will be given placebo and COVID-19 standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of secretome - mesenchymal stem cell | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (before intervention), day 7, day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before and after intervention (maximum 14 days after intervention) |
| Assessment of laboratory routine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE | Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Fatmawati | Jakarta | DKI Jakarta | Indonesia | |||
| RSUP Persahabatan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Other | Normal saline |
|
| Standard treatment of Covid-19 | Drug | Standard treatment of Covid-19 based on national protocol. |
|
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. |
| before and after intervention (maximum 14 days after intervention) |
| Assessment of photo thorax | Photo thorax will assess before and after intervention | before and after intervention (maximum 14 days after intervention) |
| Assessment of RT-PCR conversion | RT-PCR conversion will assess before and after intervention | before and after intervention (maximum 14 days after intervention) |
| Mortality rate | maximum 14 days after intervention |
| Jakarta |
| DKI Jakarta |
| Indonesia |
| RSUPN Dr. Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta | Indonesia |
| Rumah Sakit Universitas Indonesia | Depok | West Java | Indonesia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |