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.
Study Type
OBSERVATIONAL
Enrollment
100
Shuguang Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Pudong Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTime to sustained clinical recovery
Time to sustained clinical recovery
Time frame: Up to 28 days
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
Time frame: 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
Time frame: Day 1 to 28 days
Time to sustained disappearance of clinical symptoms
Time to sustained disappearance of clinical symptoms
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 3, 5, 7, 10, 14, 21 and 28
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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
Time frame: 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
Time frame: 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
Time frame: Up to 28 days