An Observational, Real World Study to Observe Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Shanghai Pudong Hospital2 sites in 1 country100 target enrollmentMay 2, 2022

ConditionsCOVID-19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: Shanghai Pudong Hospital
Enrollment: 100
Locations: 2
Primary Endpoint: Time to sustained clinical recovery
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2, 2022

End Date

April 30, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Pudong Hospital

Responsible Party

Sponsor

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
•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.

Outcomes

Primary Outcomes

Time to sustained clinical recovery

Time Frame: Up to 28 days

Time to sustained clinical recovery

Secondary Outcomes

Percentage of participants with no clinical symptoms(Day 3, 5, 7, 10, 14, 21 and 28)
Percentage of the participants who have progression of COVID-19(Day 1 to 28 days)
Percentage of clinical recovery participants(Day 3, 5, 7, 10, 14, 21 and 28)
The change of SARS-COV-2 Ct value(Day 3, 5, 7, 10, 14)
The change of COVID-19 symptom scores(Day 3, 5, 7, 10, 14, 21 and 28)
Percentage of participants who experience these events(Day 1 to 28 days)
Time to sustained disappearance of clinical symptoms(Up to 28 days)
Percentage of participants who turned negative for SARS-CoV-2(Day 3, 5, 7, 10, 14)
Safety assessment Results: such as AEs and SAEs through Day 28(Up to 28 days)