Clinical trial NCT05366244: An Observational Study in Patients With Mild to Moderate COVID-19
Official title: An Observational, Real World Study to Observe 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
Collaborators: name: ShuGuang Hospital
First posted: 2022-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild to Moderate COVID-19

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.

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.

Primary outcomes:
measure: Time to sustained clinical recovery
timeFrame: Up to 28 days
Secondary 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
measure: Time to sustained disappearance of clinical symptoms
timeFrame: Up to 28 days
measure: Percentage of clinical recovery participants
timeFrame: Day 3, 5, 7, 10, 14, 21 and 28
measure: Percentage of participants with no clinical symptoms
timeFrame: Day 3, 5, 7, 10, 14, 21 and 28
measure: The change of COVID-19 symptom scores
timeFrame: Day 3, 5, 7, 10, 14, 21 and 28
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: Shuguang Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pudong Hospital
name: Minghua Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: ShuGuang Hospital
name: Yueqiu Gao
role: PRINCIPAL_INVESTIGATOR
References: