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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19 Patient

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Need for relevant medical support (not related to COVID-19) (eg tracheostomy, gastrostomy or positive pressure ventilation, etc.) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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