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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Minghua Yu; Phone Number: +86-18017821601; Email: minghua_md@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Pudong Hospital
      • Contact: Minghua Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild to Moderate COVID-19

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient with COVID-19; Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sustained clinical recovery	Time to sustained clinical recovery	Up to 28 days
Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 28 days
Time to initial negative conversion of SARS-COV-2	Time to initial negative conversion of SARS-COV-2	Up to 28 days
Time to sustained negative conversion of SARS-CoV-2	Time to sustained negative conversion of SARS-CoV-2	Up to 28 days
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital
• Investigators: Principal Investigator: Minghua Yu, Shanghai Pudong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Mild to Moderate COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JT001-011-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No