A Real-world Retrospective Study of Disease Outcomes in Non-severe COVID-19 Patient

August 4, 2022 updated by: Shanghai Vinnerna Biosciences Co., Ltd.

A Real-world Retrospective Study of Disease Outcomes in Non-severe Coronavirus Disease 2019 (COVID-19) Patients With Risk Factors for Severe COVID-19

Retrospective analysis of real-world disease outcomes in non-severe COVID-19 patients with high risk factors of progression to severe disease, including death, without definitive anti-SARS-CoV-2 treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a retrospective, observational, real-world study to review outcomes of Mild to Moderate COVID-19 patients admitted to Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine (hereinafter referred to as Ruijin Hospital) from March to June 2022. These patients should be with risk factors for progression to severe disease (including death) and without definitive anti-novel coronavirus (SARS-CoV-2) treatment. The database of this study will be the hospital information system (HIS) of Ruijin Hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Guang Ning, doctor
        • Principal Investigator:
          • Guang Ning, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

non-severe coronavirus disease 2019 (COVID-19) patients with risk factors for severe COVID-19

Description

Inclusion Criteria:

  1. Age ≥18 years old;
  2. A record of positive SARS-CoV-2 nucleic acid test results on the day of admission or on the second day;
  3. Diagnosed as mild or common novel coronavirus pneumonia on admission, or with at least one of the following COVID-19-related symptoms on admission: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea , shortness of breath or difficulty breathing, chills or chills;

  4. Documented or diagnosed high risk factors for progression to severe COVID-19 (including death) with one or more of the following:

    • Age ≥ 60 years
    • Cardiovascular disease (including congenital heart disease) or high blood pressure
    • Chronic lung disease (eg chronic obstructive pulmonary disease [COPD], asthma [moderate to severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
    • diabetes
    • Has an immunosuppressive disorder or is receiving immunosuppressive therapy (eg, long-term use of corticosteroids or other immunosuppressive drugs leading to decreased immune function)
    • Obese or overweight (BMI>25 kg/m2)
    • Sickle cell disease
    • Active cancer
    • Chronic kidney disease
    • Current smokers
    • Neurodevelopmental disorders (eg, cerebral palsy, Down syndrome) or other conditions that cause medical complexity (eg, genetic or metabolic syndrome and severe congenital anomalies)
    • Need for relevant medical support (not related to COVID-19) (eg tracheostomy, gastrostomy or positive pressure ventilation, etc.)

Exclusion Criteria:

  1. Diagnosed with severe/critical COVID-19 before or on the day of admission;

  2. There is a data record of having received the following treatments before progression to severe/critical COVID-19:

    • Nematicavir/ritonavir combination package (ie Paxlovid)
    • SARS-CoV-2 monoclonal antibody (Ambavirumab/Romisevirumab)
    • Convalescent COVID-19 plasma
    • Other anti-SARS-CoV-2 drugs under investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with COVID-19 progression
Time Frame: up to 3 months
Percentage of patients with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from any cause).
up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants
Time Frame: up to 3 months

Percentage of participants who experience these events

  • Progress to severe COVID-19
  • Progress to critical COVID-19
  • Death from any cause
  • Admission to ICU
  • Mechanical Ventilation
  • Progress to severe COVID-19
  • Progress to critical COVID-19
  • Death from any cause
  • Admission to ICU
  • Mechanical Ventilation
up to 3 months
SARS-CoV-2
Time Frame: up to 3 months
Time from first SARS-CoV-2 positive to continuous negative
up to 3 months
SARS-CoV-2 continuous negative
Time Frame: up to 3 months
Time from admission to SARS-CoV-2 continuous negative
up to 3 months
SARS-CoV-2 Ct values
Time Frame: up to 3 months
Changes in SARS-CoV-2 Ct values
up to 3 months
chest CT scan
Time Frame: up to 3 months
Changes in chest CT scan
up to 3 months
Length of hospital stay
Time Frame: up to 3 months
Length of hospital stay related to COVID-19
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of vital signs (respiration)beats per minute
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of vital signs (blood pressure) (mm Hg)
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of vital signs (body temperature)(℃)
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of vital signs (pulse) (beats per minute)
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of laboratory(Hematology, clinical chemistry, urinalysis)
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of electrocardiogram: heart rate.
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of electrocardiogram: P-R interval
up to 3 months
safety
Time Frame: up to 3 months
Abnormal results of electrocardiogram: QTcF interval
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Vinnerna Biosciences Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juan Ma, Associate Medical Director, Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JT001-013-COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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