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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366244
• Other study ID #: JT001-010x-COVID-19
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Pudong Hospital
• Contact: Minghua Yu
• Phone: +86-18017821601
• Email: minghua_md[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai	Shanghai
China	Shuguang Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital	ShuGuang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sustained clinical recovery	Time to sustained clinical recovery	Up to 28 days
Secondary	Percentage of the participants who have progression of COVID-19	Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause	Day 1 to 28 days
Secondary	Percentage of participants who experience these events	Percentage of participants who experience these events: Progress to severe and/or critical COVID-19; Death from any cause	Day 1 to 28 days
Secondary	Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 28 days
Secondary	Percentage of clinical recovery participants	Percentage of clinical recovery participants from baseline to Day 3, 5, 7, 10, 14, 21 and 28	Day 3, 5, 7, 10, 14, 21 and 28
Secondary	Percentage of participants with no clinical symptoms	Percentage of participants with no clinical symptoms from baseline to Day 3, 5, 7, 10, 14, 21 and 28	Day 3, 5, 7, 10, 14, 21 and 28
Secondary	The change of COVID-19 symptom scores	The change of "COVID-19 symptom scores" from baseline to Day 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom.	Day 3, 5, 7, 10, 14, 21 and 28
Secondary	Percentage of participants who turned negative for SARS-CoV-2	Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14	Day 3, 5, 7, 10, 14
Secondary	The change of SARS-COV-2 Ct value	The change of SARS-COV-2 Ct value The change of SARS-COV-2 Ct value at Day 3, 5, 7, 10, 14	Day 3, 5, 7, 10, 14
Secondary	Safety assessment Results: such as AEs and SAEs through Day 28	Safety assessment Results: such as AEs and SAEs through Day 28	Up to 28 days