Observational Cohort of COVID-19 Patients in Hubei Province (OCCP-HP)

Observational Cohort of The Effects of Clinical Indicators, Drug Use and Genotypes on The Clinical Prognosis of COVID-19 Patients in Hubei Province

This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

Study Overview

• Status: Completed
• Conditions: 2019 Novel Coronavirus Disease
• Intervention / Treatment: Other: No intervention

Detailed Description

Hubei Province, as the forefront of the fight against epidemic, has the largest number of patients infected with SARS-CoV-2 and the highest quality medical data. However, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. By fully mining and analyzing these data, we can sum up a large number of experiences related to COVID-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute China's experience to the global fight against the epidemic.

Based on the above background, this study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

• Study Type: Observational
• Enrollment (Actual): 68000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study is a hospital-based observational study initiated by Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology. Trained researchers are responsible for screening and joining the group. About 6,8000 COVID-19 patients in Hubei Province were expected to be included in this study. Patients enrolled in the group will undergo baseline survey and follow-up according to the program.

Description

Inclusion Criteria:

1. Age ≥ 18, regardless of gender;
2. A history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset;
3. Corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of COVID-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease;
4. Clear etiological evidence, including real-time fluorescent RT-PCR detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus.

Exclusion Criteria:

Patients who meet any of the following criteria cannot be enrolled in this study:

1. Patients refused to participate in this study;
2. According to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with coronavirus disease 2019 (COVID-19); Patients diagnosed with COVID-19 in Hubei Province	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Numbers and dates of death in each group	2 years

Collaborators and Investigators

• Sponsor: Dao Wen Wang

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Risk Factors; Mortality
• 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: TJ-COVID

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