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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05835102
Other study ID # 2023-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date August 1, 2023

Study information

Verified date April 2023
Source The Second Affiliated Hospital of Chongqing Medical University
Contact Juan Kang, M.D.
Phone 8613996112052
Email 68368892@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

With the decline of virulence after the mutation of the SARS-CoV-2 , based on the national life and health and national development needs, the domestic SARS-CoV-2 infection epidemic prevention policy has changed, and the number of people infected by the SARS-CoV-2 has increased. Nutritional status is an indicator of human health and plays an important role in fighting disease. Malnutrition has been found to correlate with prognosis in patients infected with the SARS-CoV-2 infection . Timely identification and assessment of the patient's nutritional status and early implementation of relevant nutritional intervention are conducive to the recovery of the patient's condition. In clinical practice, it is necessary to improve nutrition as an aspect of the comprehensive diagnosis and treatment of patients with SARS-CoV-2 infection, but there is still a lack of relevant nutritional indicators or models to simply and accurately assess the nutritional status of patients.The purpose of this study was to evaluate the effects of PNI, NRI, GNRI, albumin level, vitamin D, chest muscle area and density on the clinical characteristics and prognosis of patients with SARS-CoV-2 infection, to find the nutritional predictors of severe disease in patients with SARS-CoV-2 infection, and to establish a simpler and more accurate nutritional evaluation model. To provide evidence for targeted nutritional interventions in patients with SARS-CoV-2 infection.


Description:

Patients with SARS-CoV-2 infection attending the Second Affiliated Hospital of Chongqing Medical University were included in the retrospective study. Participants met the inclusion and exclusion criteria. Data to be collected include age, sex, height, and weight at initial treatment; Blood routine, liver function, kidney function, coagulation function, electrolytes, vitamin D, C-reactive protein, ferritin; CT and MRI information; Underlying diseases, complications, treatment options, etc. Follow up patients until discharge or death. After the data collection, statistical methods such as chi-square test and logistic regression analysis were used to evaluate the impact of nutritional factors on the prognosis of patients infected with SARS-CoV-2 infection.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Patients with a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2 antigen test. Exclusion Criteria: 1. People with end-stage malignant tumors; 2. Nutritional intake disorders, mainly dependent on enteral and parenteral nutrition supporters; 3. paralyzed; 4. Intravenous drug addicts.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Juan Kang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death Death due to Respiratory failure or other diseases October 2022 to January 2023
Primary cure the patients with SARS-CoV-2 infection are cured and discharged from hospital October 2022 to January 2023
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