COVID-19NCT05366205
Immune Function in Elderly Patients With Mild to Moderate COVID-19 on Hemodialysis
A study testing Oral nutritional supplement and Nutrition consultation in people with COVID-19 and Hemodiafiltration, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID-19, Hemodiafiltration
- What is being tested?
- Oral nutritional supplement and Nutrition consultation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Hemodiafiltration
- Being tested
- Oral nutritional supplement, Nutrition consultation
- Keywords
- COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementDietary supplement
Enteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days.
Nutrition consultationBehavioural
Nutritional treatment advice will be given
| Study group | Role | What they receive |
|---|---|---|
| Oral nutritional supplements | Experimental | Patients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T). Receives: Dietary Supplement: Oral nutritional supplement |
| nutrition consultation | Sham comparator | Patients in this arm will receive nutrition consultation was given in addition to basic treatment. Receives: Behavioral: Nutrition consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 lymphocyte counts
Measured: Baseline to discharge date, an average of 3 weeks
lymphocyte count
Measured: Baseline to discharge date, an average of 3 weeks
T-lymphocyte subsets
CD3+, CD4+, CD8+
Measured: Baseline to discharge date, an average of 3 weeks
Secondary outcomes (10)
Change in body weight
Measured: Baseline to discharge date, an average of 3 weeks
change in white blood cell count
Measured: Baseline to discharge date, an average of 3 weeks
change in hemoglobin
Measured: Baseline to discharge date, an average of 3 weeks
change in albumin
Measured: Baseline to discharge date, an average of 3 weeks
change in C-Reactive Protein
Measured: Baseline to discharge date, an average of 3 weeks
change in procalcitonin
Measured: 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
Measured: 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
Measured: Baseline to discharge date, an average of 3 weeks
change in Geriatric nutritional risk index(GNRI) score
Higher scores mean a worse outcome
Measured: Baseline to discharge date, an average of 3 weeks
Length of hospital stay
Measured: Baseline to discharge date, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI YONGMEI, Ruijin Hospital
- Investigators
- Yongmei Shi, MD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366205
- Sponsor's protocol ID
- RJYY01
- Status last verified
- May 2022
- First submitted
- 30 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05366205
- Acronym / sponsor ID
- RJYY01
- Conditions
- COVID-19, Hemodiafiltration
- Keywords
- COVID-19, Hemodiafiltration, immune function, Oral nutritional supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral nutritional supplements | Experimental | Dietary Supplement: Oral nutritional supplementPatients in this arm will receive oral nutritional supplements 24-48 hours after admission，which is enteral nutrition emulsion(TPF-T). |
| nutrition consultation | Sham comparator | Behavioral: Nutrition consultationPatients in this arm will receive nutrition consultation was given in addition to basic treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritional supplementEnteral nutritional emulsion(TPF-T) will be given by oral intake,400ml per day, lasting for 7-10 days. | Dietary supplement | Oral nutritional supplements |
| Nutrition consultationNutritional treatment advice will be given | Behavioural | nutrition consultation |
Primary outcome
CD4 lymphocyte counts
Time frame: Baseline to discharge date, an average of 3 weeks
lymphocyte count
Time frame: Baseline to discharge date, an average of 3 weeks
T-lymphocyte subsets
Time frame: Baseline to discharge date, an average of 3 weeks
CD3+, CD4+, CD8+
10 secondary outcomes
Change in body weight
Time frame: Baseline to discharge date, an average of 3 weeks
change in white blood cell count
Time frame: Baseline to discharge date, an average of 3 weeks
change in hemoglobin
Time frame: Baseline to discharge date, an average of 3 weeks
change in albumin
Time frame: Baseline to discharge date, an average of 3 weeks
change in C-Reactive Protein
Time frame: Baseline to discharge date, an average of 3 weeks
change in procalcitonin
Time frame: Baseline to discharge date, an average of 3 weeks
change in nutritional risk screening 2002(NRS 2002) score
Time frame: Baseline to discharge date, an average of 3 weeks
change in mini nutritional assessment short-form（MNA- SF） score
Time frame: Baseline to discharge date, an average of 3 weeks
change in Geriatric nutritional risk index(GNRI) score
Time frame: Baseline to discharge date, an average of 3 weeks
Length of hospital stay
Time frame: Baseline to discharge date, an average of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongmei Shi, MD study chair
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement and Nutrition consultation in people with COVID-19 and Hemodiafiltration, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongmei Shi, MD (00862164370045 ext. 673376, shi.yongmei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4 lymphocyte counts (time frame: Baseline to discharge date, an average of 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.