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

• Conditions: COVID-19

• Registration Number: NCT05374772
• Lead Sponsor: Shanghai Pudong Hospital

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-13
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-13
• Study First Posted: 2022-05-16
• Last Update Posted: 2022-05-16
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Time to sustained negative conversion of SARS-CoV-2	Up to 28 days	Time to sustained negative conversion of SARS-CoV-2
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 clinical recovery	Up to 28 days	Time to sustained clinical recovery
Time to sustained disappearance of clinical symptoms	Up to 28 days	Time to sustained disappearance of clinical symptoms
Time to initial negative conversion of SARS-COV-2	Up to 28 days	Time to initial negative conversion of SARS-COV-2
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

Trial Locations

Locations (1)

Shanghai Pudong Hospital; 🇨🇳 Shanghai, Shanghai, China