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

Primary Purpose

COVID-19, Hemodiafiltration

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Oral nutritional supplement

Nutrition consultation

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Oral nutritional supplements

nutrition consultation

Arm Description

Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).

Patients in this arm will receive nutrition consultation was given in addition to basic treatment.

Outcomes

Primary Outcome Measures

CD4 lymphocyte counts

lymphocyte count

T-lymphocyte subsets

CD3+, CD4+, CD8+

Secondary Outcome Measures

Change in body weight

change in white blood cell count

change in hemoglobin

change in albumin

change in C-Reactive Protein

change in procalcitonin

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

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

change in Geriatric nutritional risk index(GNRI) score

Higher scores mean a worse outcome

Length of hospital stay

Full Information

NCT ID

NCT05366205

First Posted

April 30, 2022

Last Updated

May 6, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05366205

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Hemodiafiltration

Keywords

COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral nutritional supplements

Arm Type

Experimental

Arm Description

Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T).

Arm Title

nutrition consultation

Arm Type

Sham Comparator

Arm Description

Patients in this arm will receive nutrition consultation was given in addition to basic treatment.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral nutritional supplement

Intervention Description

Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition consultation

Intervention Description

Nutritional treatment advice will be given

Primary Outcome Measure Information:

Title

CD4 lymphocyte counts

Time Frame