Clinical trial NCT05374772: A Retrospective Study in Patients With Mild to Moderate COVID-19
Official title: A Retrospective, Real World Study to Analyze Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Mild to Moderate COVID-19
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild to Moderate COVID-19

Brief summary: 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: 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.

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.

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.

Primary outcomes:
measure: Percentage of the participants who have progression of COVID-19
timeFrame: Day 1 to 28 days
measure: Percentage of participants who experience these events
timeFrame: Day 1 to 28 days
Secondary outcomes:
measure: Time to sustained clinical recovery
timeFrame: Up to 28 days
measure: Time to sustained disappearance of clinical symptoms
timeFrame: Up to 28 days
measure: Time to initial negative conversion of SARS-COV-2
timeFrame: Up to 28 days
measure: Time to sustained negative conversion of SARS-CoV-2
timeFrame: Up to 28 days
measure: Percentage of participants who turned negative for SARS-CoV-2
timeFrame: Day 3, 5, 7, 10, 14
measure: The change of SARS-COV-2 Ct value
timeFrame: Day 3, 5, 7, 10, 14
measure: Safety assessment Results: such as AEs and SAEs through Day 28
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pudong Hospital
name: Minghua Yu
role: PRINCIPAL_INVESTIGATOR
References: