THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Neomune
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Oral Nutrition Supplement
Eligibility Criteria
Inclusion Criteria: Patients confirmed positive for COVID-19 Age over 17 years The patient can take food orally Exclusion Criteria: Patients with restricted fluid intake Patients who cannot take food orally suffering from diabetes mellitus and kidney failure
Sites / Locations
- Dr. M. Djamil General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group
control group
Arm Description
The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd
the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.
Outcomes
Primary Outcome Measures
length of stay
length of stay of patients in hospital
Outcome
Outcome Measures of patients (discharge or dead)
ICU Admission
A patient is likely to be admitted to ICU during intervention period
Secondary Outcome Measures
Il-6 and CRP Levels
Il-6 and CRP Levels during hospitalization
Full Information
NCT ID
NCT06004375
First Posted
August 19, 2023
Last Updated
August 19, 2023
Sponsor
Universitas Sriwijaya
Collaborators
M. Djamil General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06004375
Brief Title
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Official Title
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sriwijaya
Collaborators
M. Djamil General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to determine effect of arginine and glutamine on outcome of COVID-19 patients. The main questions it aims to answer are:
-to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome Dr. M. Djamil General Hospital Padang
Participants will given ONS containing arginine and glutamine. Researchers will compare intervention group with control group to see if ONS affected outcome of COVID-19 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Oral Nutrition Supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd
Arm Title
control group
Arm Type
Active Comparator
Arm Description
the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.
Intervention Type
Dietary Supplement
Intervention Name(s)
Neomune
Intervention Description
Neomune containing 4.8 g arginine and 2 g glutamine
Primary Outcome Measure Information:
Title
length of stay
Description
length of stay of patients in hospital
Time Frame
3 months
Title
Outcome
Description
Outcome Measures of patients (discharge or dead)
Time Frame
3 months
Title
ICU Admission
Description
A patient is likely to be admitted to ICU during intervention period
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Il-6 and CRP Levels
Description
Il-6 and CRP Levels during hospitalization
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients confirmed positive for COVID-19
Age over 17 years
The patient can take food orally
Exclusion Criteria:
Patients with restricted fluid intake
Patients who cannot take food orally
suffering from diabetes mellitus and kidney failure
Facility Information:
Facility Name
Dr. M. Djamil General Hospital
City
Padang
State/Province
West Sumatera
ZIP/Postal Code
25176
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
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