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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard therapy | No Intervention | 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. | |
| Paxlovid treatment | Active Comparator | Participants will receive paxlovid treatment on the basis of standard therapy. |
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| UC-MSCs treatment | Experimental | Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells | Biological | Participants will receive two doses of UC-MSCs treatment, each dose will contain 1*10^6 cells/kg suspended in 100 ml albumin solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index | Oxygenation index is the artery partial pressure of oxygen divided by the concentration of inhaled oxygen. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li qiang, Dr. | Contact | +86-021-38804518 | lqressh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| liu zhongming, Dr. | Shanghai East Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Shanghai Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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| paxlovid | Drug | 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. |
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