The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)

Institute of Hematology & Blood Diseases Hospital, China95 enrolled

Overview

Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

Ursodeoxycholic acidDRUG

250 mg/capsule, 2 capsules per day, for 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Prevalence of novel coronavirus infection

Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period

Time frame: Receiving 4 weeks of continuous ursodeoxycholic acid

Secondary Outcomes

The proportion of people infected with novel coronavirus who turned severe

Time frame: 8 weeks

The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus

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.

Time frame: 8 weeks

The rate of positive serological antibodies in the population of healthy volunteers

Time frame: 8 weeks

The incidence of adverse events

Time frame: 8 weeks

Data from ClinicalTrials.gov

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