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Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid | Drug | 250 mg/capsule, 2 capsules per day, for 4 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC | Tianjin | Tianjin Municipality | 300020 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 6, 2023 | Mar 7, 2023 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |