Long COVID-19
Conditions
Brief summary
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19
Interventions
BIOLOGICALUC-MSCs
Intravenous injection three times with one-month interval
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The age ranges from 18 to 85 (inclusive), regardless of gender. 2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition). 3. Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases. 4. Be expected to live longer than 1 year. 5. Volunteer to participate in this clinical study and sign the written informed consent.
Exclusion criteria
1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. 2. T lymphocyte abnormality, HIV positive. 3. Highly allergic or have a history of severe allergy. 4. Pregnant and lactating women. 5. Patients with severe autoimmune disease history; 6. Patients with uncontrolled chronic diseases or serious complications; 7. Patients with malignant tumors; 8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; 9. Patients with severe organ dysfunction 10. Other situations that the researchers think are not suitable for participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six min walking distances | Changes from baseline index at Day 30, Day 60, Day 90 and Day 180 | The maximum distance a person can walk in 6 min and acts as an endurance walking measure. |
| Lung function | Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180 | The lung function assessed using FEV1, FEV1/FVC and DLco |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the levels of Inflammatory cytokines | Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180 | The levels of Inflammatory cytokines |
| Changes of the scores of Multidimensional Fatigue Inventory | Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180 | The degree of fatigue |
Countries
China
Outcome results
None listed