Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Injection of secretome - mesenchymal stem cell
* Other: Placebo
* Drug: Standard treatment of Covid-19


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secretome - mesenchymal stem cell group (n = 20)<br>This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy | Biological: Injection of secretome - mesenchymal stem cell<br>* 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.<br>Drug: Standard treatment of Covid-19<br>* Standard treatment of Covid-19 based on national protocol.<br>|
| Placebo Comparator: Control ( n= 20)<br>This group will be given placebo and COVID-19 standard therapy | Other: Placebo<br>* Normal saline<br>Drug: Standard treatment of Covid-19<br>* Standard treatment of Covid-19 based on national protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Covid-19, secretome, mesenchymal stem cell, cytokine