An Observational Study in Patients With Mild to Moderate... | NCT05366244

Studies
An Observational Study in Patients With Mild to Moderate COVID-19

NCT05366244

Sponsor

Shanghai Pudong Hospital

Status

Unknown status

Last Update Posted

May 19, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Apr 30, 2023Estimated

First Submitted Date

May 6, 2022

First Submission Date that Met QC Criteria

May 6, 2022

First Posted Date

May 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2022

Last Update Posted Date

May 19, 2022Actual

Name	Class
ShuGuang Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study was to observe 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

Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.

The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.

The following is the general sequence of events during the 28-day evaluation period:

Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Patient with COVID-19		Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to sustained clinical recovery	Time to sustained clinical recovery	Up to 28 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
Participants who understand and agree to comply with planned study procedures.
Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
Capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute.
Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
Participants who have received convalescent COVID-19 plasma treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mild to Moderate COVID-19

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Minghua Yu	Shanghai Pudong Hospital	Principal Investigator
Yueqiu Gao	ShuGuang Hospital	Principal Investigator

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections