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The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.
The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxlovid | Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy |
| |
| Routine therapy | Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxlovid | Drug | The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral shedding time | time from the first positive testing to the first day of nucleic acid Ct value> 35 for both ORF1ab and N gene (in two consecutive). | up to 28 days |
| Percentage of the participants who have progression of COVID-19 | Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs through Day 28 | Adverse events and Serious adverse events through Day 28 | up to 28 days |
| Percentage of participants who turned negative for SARS-CoV-2 | Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Sun, MD | Contact | +86 02152889999 | aaronsf1125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Sun, MD | Huashan Hospital affliatied to Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | China |
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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 |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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| up to 28 days |
| Time to sustained clinical recovery | Time to sustained clinical recovery | up to 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |