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UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients

Primary Purpose

Mesenchymal Stem Cell, COVID-19 Pneumonia

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cells
paxlovid
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesenchymal Stem Cell focused on measuring covid-19 pneumonia, umbilical cord mesenchymal stem cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The age ranges from 18 to 75 (inclusive), regardless of gender. 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: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. 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.

Sites / Locations

  • Shanghai East Hospital, Shanghai Tongji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

standard therapy

Paxlovid treatment

UC-MSCs treatment

Arm Description

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.

Participants will receive paxlovid treatment on the basis of standard therapy.

Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment.

Outcomes

Primary Outcome Measures

Oxygenation index
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2023
Last Updated
January 10, 2023
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05682586
Brief Title
UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients
Official Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe and Critical COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized, controlled, open-labeled interventional clinical trial is to test the efficacy and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of severe and critical COVID-19 patients. The main questions it aims to answer are: 1. The efficacy of UC-MSCs in the treatment of severe and critical COVID-19 patients. 2. The safety of UC-MSCs in the treatment of severe and critical COVID-19 patients. 3. The potential immune mechanisms of UC-MSCs in the treatment of severe and critical COVID-19 patients. Participants will receive standard therapy, Paxlovid treatment or the UC-MSCs treatment. For the standard treatment, it will be conducted according the 9th edition of Chinese guidelines for COVID-19 infection. For UC-MSCs treatment, participants will be given UC-MSCs instillation at the first and fourth day after assignment. Blood examples will be taken at indicated time for arterial blood gas analysis and other tests. And participants should also objectively report their symptoms change and other information related to the treatment as listed the research protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stem Cell, COVID-19 Pneumonia
Keywords
covid-19 pneumonia, umbilical cord mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard therapy
Arm Type
No Intervention
Arm Description
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.
Arm Title
Paxlovid treatment
Arm Type
Active Comparator
Arm Description
Participants will receive paxlovid treatment on the basis of standard therapy.
Arm Title
UC-MSCs treatment
Arm Type
Experimental
Arm Description
Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment.
Intervention Type
Biological
Intervention Name(s)
umbilical cord mesenchymal stem cells
Intervention Description
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1*10^6 cells/kg suspended in 100 ml albumin solution.
Intervention Type
Drug
Intervention Name(s)
paxlovid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygenation index
Description
Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen.
Time Frame
Change from baseline Oxygenation index (PaO2/FiO2) at 1,3,7,14,28 (or before the day of discharge if participants discharge within 28 days) days after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age ranges from 18 to 75 (inclusive), regardless of gender. 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: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li qiang, Dr.
Phone
+86-021-38804518
Email
lqressh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liu zhongming, Dr.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai East Hospital, Shanghai Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Doctor
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients

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