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

Recruiting

• Conditions: COVID-19 Patient

• Registration Number: NCT05489874
• Lead Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-14
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with COVID-19 progression	up to 3 months	Percentage of patients with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from any cause).

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 3 months	Length of hospital stay related to COVID-19
Percentage of participants	up to 3 months	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
SARS-CoV-2	up to 3 months	Time from first SARS-CoV-2 positive to continuous negative
SARS-CoV-2 continuous negative	up to 3 months	Time from admission to SARS-CoV-2 continuous negative
SARS-CoV-2 Ct values	up to 3 months	Changes in SARS-CoV-2 Ct values
chest CT scan	up to 3 months	Changes in chest CT scan
safety	up to 3 months	Abnormal results of electrocardiogram: QTcF interval

Trial Locations

Locations (1)

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