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

NCT ID: NCT05374772

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-13

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with COVID-19

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pudong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minghua Yu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pudong Hospital

Locations

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Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minghua Yu

Role: CONTACT

+86-18017821601

Facility Contacts

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Minghua Yu

Role: primary

Other Identifiers

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JT001-011-COVID-19

Identifier Type: -

Identifier Source: org_study_id

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