Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

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

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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