An Observational 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 study was to observe 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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Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. The following is the general sequence of events during the 28-day evaluation period: Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.

Official Title
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An Observational, Real World Study to Observe 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. Participants who understand and agree to comply with planned study procedures. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site. Capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation. Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment). Participants who have received convalescent COVID-19 plasma treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- | --- |
| Time to sustained clinical recovery | Time to sustained clinical recovery | Up to 28 days | 

Secondary 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 | 
| Time to sustained disappearance of clinical symptoms | Time to sustained disappearance of clinical symptoms | Up to 28 days | 
| Percentage of clinical recovery participants | Percentage of clinical recovery participants from baseline to Day 3, 5, 7, 10, 14, 21 and 28 | Day 3, 5, 7, 10, 14, 21 and 28 | 
| Percentage of participants with no clinical symptoms | Percentage of participants with no clinical symptoms from baseline to Day 3, 5, 7, 10, 14, 21 and 28 | Day 3, 5, 7, 10, 14, 21 and 28 | 
| The change of COVID-19 symptom scores | The change of COVID-19 symptom scores from baseline to Day 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom. | Day 3, 5, 7, 10, 14, 21 and 28 | 
| 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