The purpose of this study was to observe real-world disease progression in mild-moderateCOVID-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.
Shuguang Hospital
Shanghai, Shanghai, China
Shanghai Pudong Hospital
Shanghai, Shanghai, China
Minghua Yu
+86-18017821601
minghua_md@fudan.edu.cn