Lung injury caused by major infectious diseases
Conditions
Interventions
Control Group:Placebo infusion(3 times)
MSC treatment group:Infusion of mesenchymal stem cells(3 times)
Sponsors
Chinese PLA General Hospital, Fifth Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including the threshold), gender is not limited, 2. Understand and sign the informed consent form, comply with the relevant requirements of this study, and agree not to participate in other studies and not to receive other immunotherapy during the study participation, 3. meet the diagnosis of severe or critical viral pneumonia and are in the advanced stage of disease: (1) the etiological diagnosis met any of the following criteria: ?Sars-cov-2 infection: Respiratory specimens (nasal/throat swabs or bronchial secretions/bronchoalveolar lavage fluid) were positive for Sars-cov-2 nucleic acid and/or antigen within 14 days, ?Adenovirus infection: positive for adenovirus nucleic acid and/or antigen in respiratory secretions or blood within 14 days, ?Influenza virus infection: positive respiratory secretions or blood for influenza virus nucleic acid and/or antigen within 14 days, ?Other respiratory virus antigens or nucleic acids were positive in respiratory secretions or blood within 14 days, (2) Imaging manifestations: chest X-ray or CT was consistent with the imaging features of viral pneumonia, manifested as multiple patchy shadows, ground glass shadows or consolidation in both lungs, (3) Severe patients meet any of the following criteria: ? Shortness of breath (RR) =30 times/min, ? at rest, pulse oxygen saturation =93%, ? arterial partial oxygen pressure (PaO2)/Oxygen absorption concentration (FiO2) =300mmHg, ? the clinical symptoms worsened progressively, and lung imaging showed that the lesion progressed significantly >50% within 24-48 hours. (4) Critically ill patients meet any of the following criteria: ? Develops respiratory failure and requires mechanical ventilation, ? go into shock, ? combined with other organ failure requires intensive care. 4. Expected survival >7 days.
Exclusion criteria
Exclusion criteria: 1)Patients tested active for HBV, HCV, HIV, or tuberculosis at the time of screening, 2) patients with solid tumors, leukemia or mental disorders; 3) there are serious comorbidities or complications of major organs: severe cardiovascular and cerebrovascular diseases: acute heart failure NYHA?; Uncontrolled myocarditis or valve disease; Malignant arrhythmia; New (=6 months) cardiovascular events (myocardial infarction or stroke); Chronic bronchitis, severe asthma, obstructive emphysema, pulmonary fibrosis and other diseases requiring long-term oxygen therapy or affecting daily activities; Other diseases that researchers believe may affect the effectiveness of treatment, 4) Unwillingness to sign informed consent forms, 5) Evidence of drug addiction within 6 months before trial entry, 6) Patients who are currently enrolled in other clinical trials and may violate this treatment regimen and observation indicators, 7) Unable or unwilling to provide informed consent or to comply with the study requirements, 8) Other serious conditions that may preclude the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of disease development events (defined as transition to critical illness or all-cause death, whichever occurred first) within 28 days of randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-Cause Mortality within 28 days of randomization;TTCI within 28 days of randomization;Total length of hospital stay within 28 days, 90 days and 180 days of randomization;Length of ICU stay within 28 days, 90 days and 180 days of randomization;All-Cause Mortality within 90 days, 180 days and 12 months of randomization;High resolution CT imaging changes at the 14th day, 28th day and 12th month of randomization;Time of virus turning negative;Pulmonary Sequential Outcome Scale Score, NEWS Score;Pulmonary function evaluation at the 28th day, 180th day and 12th month of randomization;SF-36 quality of life assessment at 180th day and 12th month;Immunological changes characteristics after randomization;Incidence of adverse events and serious adverse events after randomization; | — |
Countries
China
Contacts
Public ContactXu Zhe
Chinese PLA General Hospital, Fifth Medical Center
Outcome results
None listed