A Retrospective Study in Patients With Mild to Moderate COVID-19

Study Overview
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Brief Summary
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The purpose of this retrospective study is to analyze real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.

Detailed Description
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This study is a retrospective, real world study, without any intervention in clinical diagnosis and treatment, and only real world data are collected for analysis. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. The study will collect and analyze available symptoms, risk factors and SARS-COV-2 Ct value up to 28 days.

Official Title
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A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have a positive SARS-CoV-2 test result. Participants who have one or more mild or moderate COVID-19 symptoms. Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day 1. Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death. Exclusion Criteria: Participants who are diagnosed with severe/critical COVID-19 before Day 1. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute before Day 1. Participants who have received mechanical ventilation before Day 1. Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) before and during hospitalization. Participants who have received convalescent COVID-19 plasma treatment before and during hospitalization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with COVID-19<br>Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the participants who have progression of COVID-19 | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause | Day 1 to 28 days | 
| Percentage of participants who experience these events | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause | Day 1 to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sustained clinical recovery | Time to sustained clinical recovery | Up to 28 days | 
| Time to sustained disappearance of clinical symptoms | Time to sustained disappearance of clinical symptoms | Up to 28 days | 
| Time to initial negative conversion of SARS-COV-2 | Time to initial negative conversion of SARS-COV-2 | Up to 28 days | 
| Time to sustained negative conversion of SARS-CoV-2 | Time to sustained negative conversion of SARS-CoV-2 | 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 | Day 3, 5, 7, 10, 14 | 
| The change of SARS-COV-2 Ct value | The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14 | Day 3, 5, 7, 10, 14 | 
| Safety assessment Results: such as AEs and SAEs through Day 28 | Safety assessment Results: such as AEs and SAEs through Day 28 | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to Moderate COVID-19