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

NCT05659654 | Completed Phase 1

• 1 other identifier: QTJC2022056
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

ursodeoxycholic acid; COVID-19; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  8 weeks

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

  8 weeks

• The incidence of adverse events

  8 weeks

Study Arms (1)

Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

EXPERIMENTAL

Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

Drug: Ursodeoxycholic acid

Interventions

Ursodeoxycholic acid DRUG

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

Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 years old.
• No restriction on gender.
• Medical-related personnel (working hours \>20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
• COVID-19 nucleic acid test negative within 48 hours
• Sign the informed consent form

You may not qualify if:

• Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
• Previous infection with novel coronavirus within 6 months
• Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
• Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
• Pregnancy and lactation
• Use of drugs with which ursodeoxycholic acid is contraindicated
• Other reported health conditions that make participation in the study not in the best interest of the individual

Sponsors & Collaborators

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

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 21, 2022
• Study Start: December 16, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 8, 2023
• Last Updated: February 24, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)