Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Other: Placebo; Biological: Injection of secretome - mesenchymal stem cell; Drug: Standard treatment of Covid-19

• Registration Number: NCT05122234
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-10
• Primary Completion: 2021-07-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-13
• Study First Submitted QC: 2021-11-13
• Last Update Submitted: 2021-11-13
• Study Completion: 2021-11-14
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control ( n= 20)	Standard treatment of Covid-19	This group will be given placebo and COVID-19 standard therapy
Control ( n= 20)	Placebo	This group will be given placebo and COVID-19 standard therapy
Secretome - mesenchymal stem cell group (n = 20)	Injection of secretome - mesenchymal stem cell	This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Secretome - mesenchymal stem cell group (n = 20)	Standard treatment of Covid-19	This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy

Primary Outcome Measures

Name	Time	Method
Assessment of inflamation marker levels	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.

Secondary Outcome Measures

Name	Time	Method
Mortality rate	maximum 14 days after intervention
Assessment of clinical outcome	before and after intervention (maximum 14 days after intervention)	Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.
Assessment of photo thorax	before and after intervention (maximum 14 days after intervention)	Photo thorax will assess before and after intervention
Assessment of RT-PCR conversion	before and after intervention (maximum 14 days after intervention)	RT-PCR conversion will assess before and after intervention
Assessment of laboratory routine	before and after intervention (maximum 14 days after intervention)	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.

Trial Locations

Locations (4)

RSUPN Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

RSUP Fatmawati; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Universitas Indonesia; 🇮🇩 Depok, Jawa Barat, Indonesia

RSUP Persahabatan; 🇮🇩 Jakarta, DKI Jakarta, Indonesia