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COVID-19 PatientNCT05489874

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

An observational study of COVID-19 Patient, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Patient
How many people
2,000 participants
Where
1 siteChina
Study dates
14 Jul 2022to 30 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Age ≥18 years old;
  • A record of positive SARS-CoV-2 nucleic acid test results on the day of admission or on the second day;
  • 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;
  • 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
Show all 16Show fewer
  • 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.)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jie Wang, Project Manager contact

8618036618073

jie_wang5@junshipharma.com

Yali Pan, Project Directer contact

8618621590299

yali_pan@junshipharma.com

China1 site, 1 recruiting

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Guang Ning, doctor

    Guang Ning, doctor

    Recruiting

Other trials in China

About this study

Official title: 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

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with COVID-19 progression

    Percentage of patients with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from any cause).

    Measured: up to 3 months

Secondary outcomes (14)

  1. Percentage of participants

    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

    Measured: up to 3 months

  2. SARS-CoV-2

    Time from first SARS-CoV-2 positive to continuous negative

    Measured: up to 3 months

  3. SARS-CoV-2 continuous negative

    Time from admission to SARS-CoV-2 continuous negative

    Measured: up to 3 months

  4. SARS-CoV-2 Ct values

    Changes in SARS-CoV-2 Ct values

    Measured: up to 3 months

  5. chest CT scan

    Changes in chest CT scan

    Measured: up to 3 months

  6. Length of hospital stay

    Length of hospital stay related to COVID-19

    Measured: up to 3 months

  7. safety

    Abnormal results of vital signs (respiration)beats per minute

    Measured: up to 3 months

  8. safety

    Abnormal results of vital signs (blood pressure) (mm Hg)

    Measured: up to 3 months

  9. safety

    Abnormal results of vital signs (body temperature)(℃)

    Measured: up to 3 months

  10. safety

    Abnormal results of vital signs (pulse) (beats per minute)

    Measured: up to 3 months

  11. safety

    Abnormal results of laboratory(Hematology, clinical chemistry, urinalysis)

    Measured: up to 3 months

  12. safety

    Abnormal results of electrocardiogram: heart rate.

    Measured: up to 3 months

  13. safety

    Abnormal results of electrocardiogram: P-R interval

    Measured: up to 3 months

  14. safety

    Abnormal results of electrocardiogram: QTcF interval

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start14 Jul 2022
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489874
Sponsor's protocol ID
JT001-013-COVID-19
Status last verified
Jul 2022
First submitted
20 Jul 2022
Last updated
5 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Patient, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jie Wang, Project Manager (8618036618073, jie_wang5@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with COVID-19 progression (time frame: up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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