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Completed

NCT Number: NCT05659654

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Tianjin, Tianjin Municipality, 300020, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ursodeoxycholic acid

Drug

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

Primary outcomes

  1. Prevalence of novel coronavirus infection

    Time frame: 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 outcomes

  1. The proportion of people infected with novel coronavirus who turned severe

    Time frame: 8 weeks

    The proportion of people infected with novel coronavirus who turned severe

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

    Time frame: 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.

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

    Time frame: 8 weeks

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

  4. The incidence of adverse events

    Time frame: 8 weeks

    The incidence of adverse events

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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