An Observational Study in Patients With Mild to Moderate COVID-19

An Observational, Real World Study to Observe Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

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.

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.

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.