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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: Ursodeoxycholic acid

• Registration Number: NCT05659654
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Timeline

• Study Start: 2022-12-16
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-21
• Status Verified: 2023-03
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-08
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment	Ursodeoxycholic acid	Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 proportion of people infected with novel coronavirus who turned severe	8 weeks	The proportion of people infected with novel coronavirus who turned severe
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

Trial Locations

Locations (1)

Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC; 🇨🇳 Tianjin, Tianjin, China