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Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

U

University of Indonesia (UI)

Status and phase

Completed
Phase 3

Conditions

COVID-19

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05122234
54/FI/P-KCOVID-19.2B3/IX/2020

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Secretome - mesenchymal stem cell group (n = 20)
Experimental group
Description:
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
Treatment:
Drug: Standard treatment of Covid-19
Biological: Injection of secretome - mesenchymal stem cell
Control ( n= 20)
Placebo Comparator group
Description:
This group will be given placebo and COVID-19 standard therapy
Treatment:
Drug: Standard treatment of Covid-19
Other: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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