Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

Indonesia University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COVID-19

Interventions

Injection of secretome - mesenchymal stem cellBIOLOGICAL

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.

PlaceboOTHER

Normal saline

Standard treatment of Covid-19DRUG

Standard treatment of Covid-19 based on national protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

RSUP Fatmawati

Jakarta, DKI Jakarta, Indonesia

RSUP Persahabatan

Jakarta, DKI Jakarta, Indonesia

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Rumah Sakit Universitas Indonesia

Depok, West Java, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: Day 0 (before intervention), day 7, day 14

Secondary Outcomes

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.

Time frame: 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.

Time frame: before and after intervention (maximum 14 days after intervention)

Assessment of photo thorax

Photo thorax will assess before and after intervention

Time frame: before and after intervention (maximum 14 days after intervention)

Assessment of RT-PCR conversion

RT-PCR conversion will assess before and after intervention

Time frame: before and after intervention (maximum 14 days after intervention)

Mortality rate

Time frame: maximum 14 days after intervention

Data from ClinicalTrials.gov

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