Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis

Prospective, Randomized Controlled Study on Immune Function Regulation by Strengthening Early Oral Nutritional Supplementation in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis

This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Hemodiafiltration
• Intervention / Treatment: Dietary supplement: Oral nutritional supplement; Behavioral: Nutrition consultation

Detailed Description

COVID-19 is in the midst of a global pandemic. Elderly patients are often susceptible and at high risk. Elderly patients on maintenance hemodialysis are often accompanied by a variety of complications, malnutrition is a common complication with an incidence of 23-73%. Due to a variety of risk factors, COVID-19 infection tends to develop into severe disease, and it takes longer for nucleic acid to turn negative.

This randomized controlled trial will focus on the effects of early oral nutritional supplementation on immune function in elderly patients with mild to moderate COVID-19 on maintenance hemodialysis. The purpose of this study is to determine whether early oral nutritional supplementation can improve immune function and clinical outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongmei Shi, MD; Phone Number: 673376 00862164370045; Email: shi.yongmei@163.com
• Study Contact Backup: Name: Qianwen Jin, MD; Phone Number: 008618701708006; Email: jqw12247@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 60 and above;
2. Patients receiving hemodialysis with clinically confirmed end-stage renal disease
3. Positive diagnosis of COVID-19 by RT-PCR nasopharyngeal swab was classified as mild or moderate type
4. Patients who can eat on their own;
5. Patients had good compliance, fully understood the study content and signed informed consent.

Exclusion Criteria:

1. Contraindications of oral nutritional supplementation, such as intestinal obstruction and intestinal ischemia.
2. In an unstable state of vital signs such as shock.
3. In acute pancreatitis, cholecystitis acute attack period and 3 months after the last attack
4. Patients with moderate to severe cognitive impairment or mental diseases;
5. People who are allergic to intestinal nutrients
6. Refuse oral nutritional supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral nutritional supplements; Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).	Dietary supplement: Oral nutritional supplement; Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.
Sham Comparator: nutrition consultation; Patients in this arm will receive nutrition consultation was given in addition to basic treatment.	Behavioral: Nutrition consultation; Nutritional treatment advice will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 lymphocyte counts		Baseline to discharge date, an average of 3 weeks
lymphocyte count		Baseline to discharge date, an average of 3 weeks
T-lymphocyte subsets	CD3+, CD4+, CD8+	Baseline to discharge date, an average of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight		Baseline to discharge date, an average of 3 weeks
change in white blood cell count		Baseline to discharge date, an average of 3 weeks
change in hemoglobin		Baseline to discharge date, an average of 3 weeks
change in albumin		Baseline to discharge date, an average of 3 weeks
change in C-Reactive Protein		Baseline to discharge date, an average of 3 weeks
change in procalcitonin		Baseline to discharge date, an average of 3 weeks
change in nutritional risk screening 2002(NRS 2002) score	Scores range from 0 to 7，a score greater than or equal to 3 indicates nutritional risk	Baseline to discharge date, an average of 3 weeks
change in mini nutritional assessment short-form（MNA- SF） score	Scores range from 0 to 14，a score of 0 to 7 indicates malnutrition，8-11 indicates risk of malnutrition, 12-14 indicates normal nutrition	Baseline to discharge date, an average of 3 weeks
change in Geriatric nutritional risk index(GNRI) score	Higher scores mean a worse outcome	Baseline to discharge date, an average of 3 weeks
Length of hospital stay		Baseline to discharge date, an average of 3 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Yongmei Shi, MD, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; immune function; Hemodiafiltration; Oral nutritional supplement
• 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: RJYY01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No