Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19

Study Overview
=================
Brief Summary
-----------------
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19

Official Title
-----------------
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study

Conditions
-----------------
Long COVID-19

Intervention / Treatment
-----------------
* Biological: UC-MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age ranges from 18 to 85 (inclusive), regardless of gender. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition). 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. Be expected to live longer than 1 year. 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, HIV positive. Highly allergic or have a history of severe allergy. Pregnant and lactating women. Patients with severe autoimmune disease history; Patients with uncontrolled chronic diseases or serious complications; Patients with malignant tumors; Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; Patients with severe organ dysfunction Other situations that the researchers think are not suitable for participating in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSCs<br>UC-MSCs | Biological: UC-MSCs<br>* Intravenous injection three times with one-month interval<br>|
| Placebo Comparator: Placebo<br>0.9% Normal Saline | Biological: UC-MSCs<br>* Intravenous injection three times with one-month interval<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six min walking distances | The maximum distance a person can walk in 6 min and acts as an endurance walking measure. | Changes from baseline index at Day 30, Day 60, Day 90 and Day 180 | 
| Lung function | The lung function assessed using FEV1, FEV1/FVC and DLco | Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the levels of Inflammatory cytokines | The levels of Inflammatory cytokines | Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180 | 
| Changes of the scores of Multidimensional Fatigue Inventory | The degree of fatigue | Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180 |