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

COVID-19 Clinical Trial

Official title:

A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374772
• Other study ID #: JT001-011-COVID-19
• Status: Recruiting
• Start date: May 13, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Pudong Hospital
• Contact: Minghua Yu
• Phone: +86-18017821601
• Email: minghua_md[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 to 28 days
Primary	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	Day 1 to 28 days
Secondary	Time to sustained clinical recovery	Time to sustained clinical recovery	Up to 28 days
Secondary	Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 28 days
Secondary	Time to initial negative conversion of SARS-COV-2	Time to initial negative conversion of SARS-COV-2	Up to 28 days
Secondary	Time to sustained negative conversion of SARS-CoV-2	Time to sustained negative conversion of SARS-CoV-2	Up to 28 days
Secondary	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	Day 3, 5, 7, 10, 14
Secondary	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	Day 3, 5, 7, 10, 14
Secondary	Safety assessment Results: such as AEs and SAEs through Day 28	Safety assessment Results: such as AEs and SAEs through Day 28	Up to 28 days