Status:
UNKNOWN
Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients
Lead Sponsor:
Dermama Bioteknologi Laboratorium
Collaborating Sponsors:
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine storm syndrome. SARS-CoV-2...
Detailed Description
The current study is a multi-center, double arm, adjuvant, randomized control trial (RCT), double-blind clinical trial, to analyze the differences in the usefulness and safety of Exosome-MSC intraveno...
Eligibility Criteria
Inclusion
- Diagnosed with COVID-19 pneumonia confirmed by RT-PCR examination. Samples were obtained from nasopharyngeal swabs in patients with moderate
- There is evidence of changes in chest X-ray with a picture of COVID-19 pneumonia and/or CT-Scan of the thorax with a ground glass opacity picture
- Willing to participate in the study and sign the informed consent by the subject or family members.
Exclusion
- Diagnosed with mild COVID-19 pneumonia
- Pregnant woman or positive pregnancy test
- The subject is participating in another clinical trial.
- Have a history of anaphylactic reactions, angioedema, or allergic reactions to antibiotics (penicillin and its derivatives) or other drugs.
- Have an autoimmune disease
- Have a history of malignancy
- Undergoing hemodialysis or peritoneal dialysis
- Recuring COVID-19 sufferers
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05216562
Start Date
July 1 2021
End Date
December 30 2022
Last Update
February 18 2022
Active Locations (3)
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1
RSPAD Gatot Soebroto
Jakarta, DKI Jakarta, Indonesia, 10410
2
RSUP Dr. M. Jamil
Padang, West Sumatra, Indonesia, 25171
3
RSUP Dr. Sardjito
Yogyakarta, Indonesia, 55281