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

NCT05374772 | Unknown

• 1 other identifier: JT001-011-COVID-19
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Time to sustained clinical recovery

  Up to 28 days

• Time to sustained disappearance of clinical symptoms

  Up to 28 days

• Time to initial negative conversion of SARS-COV-2

  Up to 28 days

• Time to sustained negative conversion of SARS-CoV-2

  Up to 28 days

• Percentage of participants who turned negative for SARS-CoV-2

  Day 3, 5, 7, 10, 14

Study Arms (1)

Patient with COVID-19

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild to Moderate COVID-19

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Minghua Yu

  Shanghai Pudong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghua Yu

CONTACT

+86-18017821601; minghua_md@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 16, 2022
• Study Start: May 13, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)