Status:
WITHDRAWN
Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus
Lead Sponsor:
Puren Hospital Affiliated to Wuhan University of Science and Technology
Collaborating Sponsors:
Wuhan Hamilton Bio-technology Co., Ltd
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry...
Detailed Description
Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cas...
Eligibility Criteria
Inclusion
- Male or female, 18 years old ≤ age ≤ 75years old;
- CT image is characteristic of 2019 novel coronavirus pneumonia;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR);
- In compliance with the 2019-nCoV pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards): (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
Exclusion
- Patients with severe allergies or allergies to stem cells;
- Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc.;
- Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
- In vitro life support (ECMO, ECCO2R, RRT);
- Expected deaths within 48 hours, uncontrolled infections;
- Patients with malignant blood-borne diseases such as HIV or syphilis;
- Patient with pregnancy, are planning to become pregnant or breastfeeding;
- Patients with poor compliance and unable to complete the full study;
- The investigator determines that there may be increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of the results (such as excessive stress, sensitivity or cognitive impairment, etc.);
- There are other situations that the researchers think are not suitable to participate in this clinical study
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04293692
Start Date
February 24 2020
End Date
February 25 2020
Last Update
March 18 2020
Active Locations (1)
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1
Puren Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, China, 430081