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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Minghua Yu; Phone Number: +86-18017821601; Email: minghua_md@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201399
      • Recruiting
      • Shanghai Pudong Hospital
      • Contact: Minghua Yu
    • Shanghai, Shanghai, China, 201203
      • Recruiting
      • ShuGuang Hospital
      • Contact: Yueqiu Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild to Moderate COVID-19

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient with COVID-19; Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sustained clinical recovery	Time to sustained clinical recovery	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 28 days
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital
• Collaborators: ShuGuang Hospital
• Investigators: Principal Investigator: Minghua Yu, Shanghai Pudong Hospital; Principal Investigator: Yueqiu Gao, ShuGuang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Mild to Moderate COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JT001-010x-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No