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

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Patient

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jie Wang, Project Manager; Phone Number: 8618036618073; Email: jie_wang5@junshipharma.com
• Study Contact Backup: Name: Yali Pan, Project Directer; Phone Number: 8618621590299; Email: yali_pan@junshipharma.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Guang Ning, doctor
      • Principal Investigator: Guang Ning, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

non-severe coronavirus disease 2019 (COVID-19) patients with risk factors for severe COVID-19

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Investigators: Study Director: Juan Ma, Associate Medical Director, Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JT001-013-COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No