Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122234
• Other study ID #: 54/FI/P-KCOVID-19.2B3/IX/2020
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2020
• Est. completion date: November 14, 2021

Study information

• Verified date: November 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 14, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. All individuals aged 18 to 65 years

2. 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)

3. Categorized as a severe case of COVID-19 patient

4. Agree to participate and sign the informed consent

Exclusion Criteria:

1. History of allergy to penicillin, streptomycin, and amphotericin-B

2. Have any cancer conditions

3. Active in other intervention studies

4. Have had other intervention studies in the last 3 months

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Injection of secretome - mesenchymal stem cell
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.

Other:
• Placebo
Normal saline

Drug:
• Standard treatment of Covid-19
Standard treatment of Covid-19 based on national protocol.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Universitas Indonesia	Depok	Jawa Barat
Indonesia	RSUP Fatmawati	Jakarta	DKI Jakarta
Indonesia	RSUP Persahabatan	Jakarta	DKI Jakarta
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Assessment of photo thorax	Photo thorax will assess before and after intervention	before and after intervention (maximum 14 days after intervention)
Secondary	Assessment of RT-PCR conversion	RT-PCR conversion will assess before and after intervention	before and after intervention (maximum 14 days after intervention)
Secondary	Mortality rate		maximum 14 days after intervention