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

A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ursodeoxycholic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment; Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment	Drug: Ursodeoxycholic acid; 250 mg/capsule, 2 capsules per day, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Receiving 4 weeks of continuous ursodeoxycholic acid

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of people infected with novel coronavirus who turned severe	The proportion of people infected with novel coronavirus who turned severe	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.	8 weeks
The rate of positive serological antibodies in the population of healthy volunteers	The rate of positive serological antibodies in the population of healthy volunteers	8 weeks
The incidence of adverse events	The incidence of adverse events	8 weeks

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; prevention; ursodeoxycholic acid
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: QTJC2022056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No