Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
NCT Number: NCT06492798
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Long COVID|Post-Acute COVID-19 Syndrome
Interventions: DRUG: umbilical cord mesenchymal stem cell
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2026-08-31
Locations: Shanghai Changhai Hospital, Shanghai, 200433, China

Summary:
The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include:

* whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
* whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients.

Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted.

Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that.

Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.

Primary Outcome Measures: Common Terminology Criteria for Adverse Events (CTCAE5.0), CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome., 28th day
Secondary Outcome Measures: Common Terminology Criteria for Adverse Events (CTCAE5.0), CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome., 12th week, 24th week
Other Outcome Measures: C reactive protein(CRP), For paticipants with high C reactive protein level at enrollment, C reactive protein will be tested. Level of CRP change and time for its relief will be recorded., 28th day, 12th week, 24th week|Dosage of corticosteroids, For paticipants using corticosteroids to treat long COVID, total dosage and course of corticosteroids will be recorded., 28th day, 12th week, 24th week|SpO2, For paticipants with pulmonary fibrosis, SpO2 will be tested and evaluated., 28th day, 12th week, 24th week|6-minute walk test, For paticipants with pulmonary fibrosis, 6-minute walk testwill be tested and evaluated., 28th day, 12th week, 24th week|HRCT scan, For paticipants with pulmonary fibrosis, HRCT scan will be tested and evaluated., 28th day, 12th week, 24th week