Status:
COMPLETED
Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19)
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Huoshenshan Hospital
Maternal and Child Health Hospital of Hubei Province
Conditions:
Corona Virus Disease 2019(COVID-19)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatme...
Detailed Description
The Corona Virus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection has unprecedentedly spread in the worldwide and been declared as a pandemic b...
Eligibility Criteria
Inclusion
- Male or female, aged at 18 years (including) -75 years old
- Hospitalized
- Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
- Pneumonia that is judged by computed tomography
- In accordance with any one of the following : 1)dyspnea (RR ≥ 30 times / min), 2)finger oxygen saturation ≤ 93% in resting state, 3)arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG, 4)pulmonary imaging shows that the focus progress \> 50% in 24-48 hours
- Interstitial lung damage is judged by computed tomography.
Exclusion
- Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures;
- Patients with malignant tumor, other serious systemic diseases and psychosis;
- Patients who are participating in other clinical trials;
- Inability to provide informed consent or to comply with test requirements.
- Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
- Invasive ventilation
- Shock
- Combined with other organ failure( need organ support)
- Interstitial lung damage caused by other reasons ( in 2 weeks)
- The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04288102
Start Date
March 5 2020
End Date
July 9 2020
Last Update
August 19 2020
Active Locations (3)
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1
General Hospital of Central Theater Command
Wuhan, Hubei, China, 430000
2
Maternal and Child Hospital of Hubei Province
Wuhan, Hubei, China, 430000
3
Wuhan Huoshenshan Hospital
Wuhan, Hubei, China, 430000