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
Brief Summary

Retrospective analysis of real-world disease outcomes in non-severe COVID-19 patientswith high risk factors of progression to severe disease, including death, withoutdefinitive 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.

Unknown status
COVID-19 Patient
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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China

Investigator: Guang Ning, doctor

Investigator: Guang Ning, doctor

Contacts

Jie Wang, Project Manager
8618036618073
jie_wang5@junshipharma.com

Yali Pan, Project Directer
8618621590299
yali_pan@junshipharma.com

Juan Ma, Associate Medical Director, Study Director
Shanghai Junshi Bioscience Co., Ltd.

Shanghai Vinnerna Biosciences Co., Ltd.
NCT Number
MeSH Terms
COVID-19