Status:
UNKNOWN
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
Lead Sponsor:
Stem Cell and Cancer Research Indonesia
Collaborating Sponsors:
Provincial Government of Central Java, Indonesia
Conditions:
Covid-19
Cytokine Storm
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiologica...
Detailed Description
The devastating effect of severe acute respiratory syndrome coronavirus-2 (SARS COV-2) infection is caused by a robust cytokine storm that leads to lung tissue damage. Several studies reported a corre...
Eligibility Criteria
Inclusion
- Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.
- Patients who are willing to participate as subjects in the study by signing the informed content.
- Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:
- PaO2 / FiO2: moderate 100-200
- PaO2 / FiO2: severe \<100
- One or more comorbid history
- SOFA score
Exclusion
- The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)
- ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
- Severe NYHA III / IV heart failure
- Pregnant women
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04753476
Start Date
June 8 2020
End Date
March 1 2022
Last Update
May 24 2021
Active Locations (6)
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1
RSUD Bantul
Bantul, Central Java, Indonesia
2
RS PKU Muhammadiyah Gamping
Yogyakarta, Central Java, Indonesia, 55122
3
RS Primaya Bekasi Timur
Bekasi, Jakarta Special Capital Region, Indonesia
4
Bhayangkara Hospital
Makassar, South Celebes, Indonesia