COVID-19
Conditions
Keywords
Mild to Moderate COVID-19
Brief summary
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
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.
Interventions
None listed
Sponsors
Shanghai Pudong Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of the participants who have progression of COVID-19 | Day 1 to 28 days | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause |
| Percentage of participants who experience these events | Day 1 to 28 days | Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to initial negative conversion of SARS-COV-2 | Up to 28 days | Time to initial negative conversion of SARS-COV-2 |
| Time to sustained negative conversion of SARS-CoV-2 | Up to 28 days | Time to sustained negative conversion of SARS-CoV-2 |
| Time to sustained clinical recovery | Up to 28 days | Time to sustained clinical recovery |
| The change of SARS-COV-2 Ct value | Day 3, 5, 7, 10, 14 | The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14 |
| Safety assessment Results: such as AEs and SAEs through Day 28 | Up to 28 days | Safety assessment Results: such as AEs and SAEs through Day 28 |
| Percentage of participants who turned negative for SARS-CoV-2 | Day 3, 5, 7, 10, 14 | Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14 |
| Time to sustained disappearance of clinical symptoms | Up to 28 days | Time to sustained disappearance of clinical symptoms |
Countries
China
Contacts
Primary ContactMinghua Yu
Outcome results
None listed