NCT05122234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Aug 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

November 13, 2021

Last Update Submit

November 13, 2021

Conditions

COVID-19

Keywords

Severe Covid-19secretomemesenchymal stem cellcytokine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Assessment of clinical outcome

    before and after intervention (maximum 14 days after intervention)

  • Assessment of laboratory routine

    before and after intervention (maximum 14 days after intervention)

  • Assessment of photo thorax

    before and after intervention (maximum 14 days after intervention)

  • Assessment of RT-PCR conversion

    before and after intervention (maximum 14 days after intervention)

  • Mortality rate

    maximum 14 days after intervention

Study Arms (2)

Secretome - mesenchymal stem cell group (n = 20)

EXPERIMENTAL

This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy

Biological: Injection of secretome - mesenchymal stem cellDrug: Standard treatment of Covid-19

Control ( n= 20)

PLACEBO COMPARATOR

This group will be given placebo and COVID-19 standard therapy

Other: PlaceboDrug: Standard treatment of 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.

Secretome - mesenchymal stem cell group (n = 20)
PlaceboOTHER

Normal saline

Control ( n= 20)
Standard treatment of Covid-19DRUG

Standard treatment of Covid-19 based on national protocol.

Control ( n= 20)Secretome - mesenchymal stem cell group (n = 20)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

RSUP Fatmawati

Jakarta, DKI Jakarta, Indonesia

Location

RSUP Persahabatan

Jakarta, DKI Jakarta, Indonesia

Location

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Location

Rumah Sakit Universitas Indonesia

Depok, West Java, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE

    Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.D., PhD, FACG, FASGE

Study Record Dates

First Submitted

November 13, 2021

First Posted

November 16, 2021

Study Start

August 10, 2020

Primary Completion

July 30, 2021

Study Completion

November 14, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

ID(4)