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

NCT ID: NCT05489874

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2024-12-30

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

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.

Conditions

COVID-19 Patient

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Vinnerna Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Ma, Associate Medical Director

Role: STUDY_DIRECTOR

Shanghai Junshi Bioscience Co., Ltd.

Locations

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Wang, Project Manager

Role: CONTACT

jie_wang5@junshipharma.com

8618036618073

Yali Pan, Project Directer

Role: CONTACT

yali_pan@junshipharma.com

8618621590299

Facility Contacts

Guang Ning, doctor

Role: primary

Other Identifiers

JT001-013-COVID-19

Identifier Type: -

Identifier Source: org_study_id