COVID-19
Conditions
Keywords
ursodeoxycholic acid, COVID-19, prevention
Brief summary
Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers
Detailed description
This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.
Interventions
DRUGUrsodeoxycholic acid
250 mg/capsule, 2 capsules per day, for 4 weeks
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 - 65 years old. 2. No restriction on gender. 3. Medical-related personnel (working hours \>20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students 4. COVID-19 nucleic acid test negative within 48 hours 5. Sign the informed consent form
Exclusion criteria
1. Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste 2. Previous infection with novel coronavirus within 6 months 3. Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs 4. Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment 5. Pregnancy and lactation 6. Use of drugs with which ursodeoxycholic acid is contraindicated 7. Other reported health conditions that make participation in the study not in the best interest of the individual
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of novel coronavirus infection | Receiving 4 weeks of continuous ursodeoxycholic acid | Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of people infected with novel coronavirus who turned severe | 8 weeks | The proportion of people infected with novel coronavirus who turned severe |
| The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus | 8 weeks | The number of days that symptoms of a novel coronavirus infection such as fever, sore throat, headache, and muscle aches persisted in the population infected with novel coronavirus, and the number of days that the nucleic acid/antigen turned negative. |
| The rate of positive serological antibodies in the population of healthy volunteers | 8 weeks | The rate of positive serological antibodies in the population of healthy volunteers |
| The incidence of adverse events | 8 weeks | The incidence of adverse events |
Countries
China
Outcome results
None listed