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Efficacy and safety study of ursodeoxycholic acid (UDCA) in Chinese COVID-19 pediatric patients: A randomized, open-label, controlled clinical study

A randomized, open-label, controlled, single-center clinical study evaluating the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of novel coronavirus infection in children 1 month to 18 years of age

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067226
Enrollment
Unknown
Registered
2022-12-30
Start date
2022-12-30
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

novel coronavirus pneumonia (COVID-19)

Interventions

Ursodeoxycholic acid (UDCA) treatment group:Conservative treatment + oral administered ursodeoxycholic acid (10-15 mg/kg/d, twice a day, maximum dose 0.25g, twice a day, for 5 days)

Sponsors

Xiamen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed mild or moderate SARS-CoV-2 infection; 2. No gender limit, aged 1 month to 18 years; 3. Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment; 4. Normal function of major organs (heart, liver, lungs, kidneys); 5. The guardians were fully informed and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious diseases such as tumor, immune deficiency or organ transplantation; 2. Patients with convulsion; 3. Infected persons with other pathogens; 4. Patients taking antibiotics, hormones and immunosuppressants at the same time; 5. Ursodeoxycholic acid is contraindicated; 6. The researcher believes that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Proportion of participants with clinical improvement;Ct value of COVID-19 nucleic acid in throat swabs;

Secondary

MeasureTime frame
Serum ACE2 level;Serum cytokine level;

Countries

China

Contacts

Public ContactYu Hui

Xiamen Children's Hospital

yuhui4756@sina.com+86 15900895238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026