A Retrospective Study in Patients With Mild to Moderate COVID-19

Shanghai Pudong Hospital

Status: Unknown

Conditions: COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT05374772

JT001-011-COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Patient with COVID-19

Description:

Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death.