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NCT Number: NCT05122234

Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RSUP Fatmawati, Jakarta, DKI Jakarta, Indonesia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Injection of secretome - mesenchymal stem cell

Biological

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.

Placebo

Other

Normal saline

Standard treatment of Covid-19

Drug

Standard treatment of Covid-19 based on national protocol.

Primary outcomes

  1. Assessment of inflamation marker levels

    Time frame: 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 outcomes

  1. Assessment of clinical outcome

    Time frame: 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.

  2. Assessment of laboratory routine

    Time frame: 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.

  3. Assessment of photo thorax

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

    Photo thorax will assess before and after intervention

  4. Assessment of RT-PCR conversion

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

    RT-PCR conversion will assess before and after intervention

  5. Mortality rate

    Time frame: maximum 14 days after intervention

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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