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

NCT05489874 | Unknown

• 1 other identifier: JT001-013-COVID-19
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID-19 Patient

Outcome Measures

Primary Outcomes (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).

  up to 3 months

Secondary Outcomes (14)

• Percentage of participants

  up to 3 months

• SARS-CoV-2

  up to 3 months

• SARS-CoV-2 continuous negative

  up to 3 months

• SARS-CoV-2 Ct values

  up to 3 months

• chest CT scan

  up to 3 months

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

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

• Juan Ma, Associate Medical Director

  Shanghai Junshi Bioscience Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jie Wang, Project Manager

CONTACT

8618036618073; jie_wang5@junshipharma.com

Yali Pan, Project Directer

CONTACT

8618621590299; yali_pan@junshipharma.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 5, 2022
• Study Start: July 14, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-07

Locations

CN (1)