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

Shanghai Pudong Hospital

Status: Unknown

Conditions: COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT05366244

JT001-010x-COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patient with COVID-19

Description:

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