Prediction Models for Diagnosis and Prognosis of Severe COVID-19

NCT04525287 | Completed DMC

• 1 other identifier: 2020-12020001231
• Study Type: observational
• Target: 617
• Locations: 1 country
• Sites: 6

Brief Summary

Clinical observation has found that COVID-19 patients often present inconsistency of clinical features, nucleic acid of the SARS-CoV-2 and imaging findings, which brings challenges to the management of patients.The quantitative assessment of patients' pulmonary lesions of chest CT, combined with the basic information, epidemiological history, clinical symptoms, basic diseases and other information of patients, will quickly establish a reliable prediction model for the severe COVID-19. This model will greatly contribute to the effective diagnosis and treatment of COVID-19.

Conditions

Coronavirus Infection; COVID19

Outcome Measures

Primary Outcomes (1)

• Chest CT and clinical features

  chest CT imaging data of the patient, basic patient information, epidemiological history, clinical symptoms, and underlying diseases

  2020-1-1 to 2020-6-1

Study Arms (2)

Severe COVID-19

Patients who have one of the following conditions during treatment: 1. Respiratory distress, RR≥30 beats/min; 2. In resting state, mean oxygen saturation≤93%; 3. Arterial oxygen partial pressure ( PaO2)/Inhalation Oxygen Concentration (FiO2) ≤300mmHg (1mmHg=0.133kPa); 4. Respiratory failure occurs and mechanical ventilation is required; 5. Shock occurs; 6. ICU monitoring and treatment is required for combined other organ failure.

Mild COVID-19

The patient only showed symptoms such as fever and respiratory tract in general, and no severe symptoms occurred during the visit and follow-up.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1,000 cases of COVID-19 patients who were tested positive for nucleic acid of the SARS-CoV-2 in more than ten designated hospitals within and outside Zhejiang Province. all underwent chest HRCT examination and relatively complete clinical and laboratory data.

You may qualify if:

• The patient was tested positive for nucleic acid of the SARS-CoV-2

You may not qualify if:

• none

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (6)

Department of radiology, The Second People's Hospital, Fuyang, Anhui, China

Fuyang, Zhejiang, China

Location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location

Department of Radiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China

Jiaxing, Zhejiang, China

Location

Department of Radiology, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China

Taizhou, Zhejiang, China

Location

Department of Radiology, Ruian People's Hospital, The Third Affiliated Hospital of Wenzhou Medical University, Ruian, Zhejiang, China

Wenzhou, Zhejiang, China

Location

Department of Radiology, Yueqing People's Hospital, Yueqing, Wenzhou, Zhejiang, China

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: February 20, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: August 6, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)