Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID 19 Pneumonia
  • Cyotokine Storm
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This is an Interventional, Prospective, Open label (Voluntary Assignment), single to multiple center expansion, unmatched controlled, Sequentially Interim analysis tested TrialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Description

While most patients with SARS-CoV-2 present with mild respiratory disease with the most common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS. The overall mortality rate is 2% but varies by country and age of the patient. In COVID-19 ARDS standard supportive ca...

While most patients with SARS-CoV-2 present with mild respiratory disease with the most common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS. The overall mortality rate is 2% but varies by country and age of the patient. In COVID-19 ARDS standard supportive care and treatment for underlying illnesses remain the mainstay with limited success. Numerous antiviral medications including remdesivir, lopinavir-ritonavir or lopinavir-ritonavir and interferon Beta-1a are in clinical trials but safety and efficacy remain unclear. Inflammation associated with a cytokine storm begins at a local site and spreads throughout the body via systemic circulation. The lungs and other organs are damaged with progressive inflammation. Mesenchymal cells offer the potential to treat viral infection both directly and through reducing the immune response. MSCs play a role as an immunomodulator, which is safe and effective as demonstrated in numerous clinical trials. Mesenchymal cells are a potential privileged cell-based therapy in SARS-CoV-2. MSCs derived extracellular vesicles have demonstrated comparable and sometimes more effective effects in ameliorating lung inflammation and injury.

Tracking Information

NCT #
NCT04352803
Collaborators
Not Provided
Investigators
Not Provided