UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients
NCT ID: NCT05682586
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2023-01-09
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard therapy
Participants will receive standard therapy, including oxygen therapy，glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection.
No interventions assigned to this group
Paxlovid treatment
Participants will receive paxlovid treatment on the basis of standard therapy.
paxlovid
Participants will receive standard dose of paxlovid therapy, which contains 300mg namatevir and 100mg litonavir twice a day for a total course of 5 days.
UC-MSCs treatment
Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment.
umbilical cord mesenchymal stem cells
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution.
Interventions
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umbilical cord mesenchymal stem cells
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution.
paxlovid
Participants will receive standard dose of paxlovid therapy, which contains 300mg namatevir and 100mg litonavir twice a day for a total course of 5 days.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with severe and critical COVID-19 pneumonia within one week, according to the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative Ninth Edition).
* 20kg/m2≤body mass index（BMI）≤30 kg/m2.
* Volunteer to participate in this clinical study and sign the written informed consent.
Exclusion Criteria
* T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive.
* Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy.
* Pregnant and lactating women.
* Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2.
* Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score\>7); Patients with malignant tumors.
* Patients with pulmonary embolism or acute coronary syndrome.
* Patients with severe organ dysfunction caused by other diseases.
* There are other situations that the researcher thinks are not suitable to participate in this clinical study.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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liu zhongming, Dr.
Role: STUDY_CHAIR
Shanghai East Hospital
Locations
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Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DFSC-2022(CR)-05
Identifier Type: -
Identifier Source: org_study_id
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