Clinical trial NCT05489874: A Real-world Retrospective Study of Disease Outcomes in Non-severe COVID-19 Patient
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Patient
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 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.

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

Primary outcomes:
measure: Percentage of patients with COVID-19 progression
timeFrame: up to 3 months
Secondary outcomes:
measure: Percentage of participants
timeFrame: up to 3 months
measure: SARS-CoV-2
timeFrame: up to 3 months
measure: SARS-CoV-2 continuous negative
timeFrame: up to 3 months
measure: SARS-CoV-2 Ct values
timeFrame: up to 3 months
measure: chest CT scan
timeFrame: up to 3 months
measure: Length of hospital stay
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
measure: safety
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Junshi Bioscience Co., Ltd.
name: Juan Ma, Associate Medical Director
role: STUDY_DIRECTOR
References: