THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: Neomune

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • West Sumatera
    • Padang, West Sumatera, Indonesia, 25176
      • Dr. M. Djamil General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; 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	Dietary supplement: Neomune; Neomune containing 4.8 g arginine and 2 g glutamine
Active Comparator: control group; the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.	Dietary supplement: Neomune; Neomune containing 4.8 g arginine and 2 g glutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	length of stay of patients in hospital	3 months
Outcome	Outcome Measures of patients (discharge or dead)	3 months
ICU Admission	A patient is likely to be admitted to ICU during intervention period	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Il-6 and CRP Levels	Il-6 and CRP Levels during hospitalization	3 months

Collaborators and Investigators

• Sponsor: Universitas Sriwijaya
• Collaborators: M. Djamil General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: August 19, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Oral Nutrition 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: ID

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