Coronavirus Disease 2019 (COVID-19) Clinical Trial
Official title:
Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
COVID-19 has become a urgent and serious public health event that threatens human life and
health globally. No specific pharmacological treatments are available to date for
COVID-19.Patients contracting the severe form of the disease constitute approximately 15% of
the cases which is characterized by extensive acute inflammation. In these severe cases,
there will be rapid respiratory system failure.
MSCs have been employed extensively in cell therapy, which includes a plethora of preclinical
research investigations as well as a significant number of clinical trials. Safety and
efficacy have been shown in many clinical trials. Previous studies have shown that MSCs could
significantly reduce inflammatory cell infiltration in lung tissue, reduce inflammation in
lung tissue, and significantly improve lung The structure and function of tissues protect
lung tissue from damage.The mechanisms underlying the improvements after MSC infusion in
COVID-19 patients also appeared to be the robust antiinflammatory activity of MSCs. Recent
studies also showed that intravenous MSC infusion could reduce the overactivation of the
immune system and support repair by modulating the lung microenvironment after SARS-CoV-2
infection. MSC therapy inhibiting the overactivation of the immune system and promoting
endogenous repair by improving the lung microenvironment after the SARS-CoV-2 infection.
The purpose of this study is to investigate the safety and efficacy of intravenous infusion
of mesenchymal stem cells in severe patients With COVID-19.The respiratory function,
pulmonary inflammation, clinical symptoms, pulmonary imaging, side effects, immunological
characteristics will be evaluated.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04516564 -
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT04395170 -
Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT04519424 -
CSL324 in COVID-19
|
Phase 2 | |
| Completed |
NCT05437289 -
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
|
Phase 1 | |
| Completed |
NCT05594147 -
An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib
|
||
| Withdrawn |
NCT04848467 -
COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older
|
Phase 3 | |
| Completed |
NCT04588363 -
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
|
||
| Terminated |
NCT04877743 -
Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
|
||
| Completed |
NCT04742725 -
A Study to Evaluate the Efficacy and Safety of Prothione™ Capsules for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
|
Phase 2 | |
| Completed |
NCT04375761 -
COVID-19: Human Epidemiology and Response to SARS-CoV-2
|
||
| Completed |
NCT04378777 -
Immunophenotyping Assessment in a COVID-19 Cohort
|
||
| Completed |
NCT04545047 -
Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
|
||
| Completed |
NCT04327206 -
BCG Vaccination to Protect Healthcare Workers Against COVID-19
|
Phase 3 | |
| Terminated |
NCT05375760 -
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
|
Phase 2 | |
| Completed |
NCT04344977 -
Collection of Anti-SARS-CoV-2 Immune Plasma
|
||
| Terminated |
NCT04389840 -
Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
|
Phase 2/Phase 3 | |
| Withdrawn |
NCT04425733 -
MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)
|
Phase 1 | |
| Not yet recruiting |
NCT04438837 -
Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers
|
N/A | |
| Completed |
NCT04409509 -
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
|
Phase 2 | |
| Completed |
NCT04275245 -
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
|
Phase 1/Phase 2 |