Status:
COMPLETED
A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai Public Health Clinical Center
Wuhan Jinyintan Hospital, Wuhan, China
Conditions:
Coronavirus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hu...
Detailed Description
Since December 2019, SARS-CoV-2 infection has become a worldwide urgent public health event, especially in China. As of February 13, 2020, over 63,000 cases have been confirmed with over 10,200 severe...
Eligibility Criteria
Inclusion
- Willingness of study participant to accept this treatment arm, and signed informed consent; 2.Male or female, aged at 18 years (including) to 75 years old; 3.Patients with confirmed novel coronavirus pneumonia; 4.Confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from respiratory tract or blood specimens; 5.Diagnostic criteria of "Severe" or " Critical":
- Severe, comply with any of the following:
- Respiratory distress, Respiratory rate (RR) ≥ 30 times/min
- Pulse oxygen saturation (SpO2) at rest ≤ 93%
- Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300mmHg
- Critical, comply with any of the following:
- Respiratory failure, and requirement for mechanical ventilation
- Shock
- Other organ failure and requirement for ICU monitoring
Exclusion
- Allergic or hypersensitive to any of the ingredients;
- Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses;
- Obstructive HABP/VABP induced by lung cancer or other known causes;
- Carcinoid syndrome;
- History of long-term use of immunosuppressive agents;
- History of epilepsy and requirement for continuous anticonvulsant treatment or anticonvulsant treatment received within the last 3 years;
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
- Undergoing hemodialysis or peritoneal dialysis;
- Estimated or actual rate of creatinine clearance \< 15 ml/min;
- History of moderate and severe liver disease (Child-Pugh score \>12);
- Expectation of receiving any of following medications during the study:
- Receiving continuous valproic acid or sodium valproate within the first 2 weeks prior to screening
- Receiving 5-transtryptamine reuptake inhibitors, tricyclic antidepressants, 5-HT1 receptor agonists or monoamine oxidase inhibitors within the first 2 weeks prior to screening
- Incapable of understanding study protocol;
- History of deep venous thrombosis or pulmonary embolism within the last 3 years;
- Undergoing ECMO or high-frequency oscillatory ventilation support;
- HIV, hepatitis virus, or syphilis infection;
- Period of pregnancy or lactation, or planned pregnancy within 6 months;
- Any condition of unsuitable for the study determined by investigators.
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04276987
Start Date
February 15 2020
End Date
July 31 2020
Last Update
September 7 2020
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025