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

NCT05366244 | Unknown

• 1 other identifier: JT001-010x-COVID-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to sustained clinical recovery

  Time to sustained clinical recovery

  Up to 28 days

Secondary Outcomes (9)

• Percentage of the participants who have progression of COVID-19

  Day 1 to 28 days

• Percentage of participants who experience these events

  Day 1 to 28 days

• Time to sustained disappearance of clinical symptoms

  Up to 28 days

• Percentage of clinical recovery participants

  Day 3, 5, 7, 10, 14, 21 and 28

• Percentage of participants with no clinical symptoms

  Day 3, 5, 7, 10, 14, 21 and 28

Study Arms (1)

Patient with COVID-19

Mild to moderate COVID-19 patient with at least one risk factor for serve COVID-19 illness or death.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild to Moderate COVID-19

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead
• ShuGuang Hospital: collaborator

Study Sites (2)

Shuguang Hospital

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Minghua Yu

  Shanghai Pudong Hospital

  PRINCIPAL INVESTIGATOR

• Yueqiu Gao

  ShuGuang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghua Yu

CONTACT

+86-18017821601; minghua_md@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 9, 2022
• Study Start: May 2, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)