Status:
UNKNOWN
An Observational Study in Patients With Mild to Moderate COVID-19
Lead Sponsor:
Shanghai Pudong Hospital
Collaborating Sponsors:
ShuGuang Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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-invas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05366244
Start Date
May 2 2022
End Date
April 30 2023
Last Update
May 19 2022
Active Locations (2)
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1
Shuguang Hospital
Shanghai, Shanghai Municipality, China, 201203
2
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China, 201399