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

• Sponsor: Universitas Sriwijaya (Other)
• Overall Status: Completed
• CT.gov ID: NCT06004375
• Collaborator: M. Djamil General Hospital (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 0.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Dietary Supplement: Neomune	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: May 30, 2023
• Actual Study Completion Date: May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. length of stay [3 months]

   length of stay of patients in hospital

2. Outcome [3 months]

   Outcome Measures of patients (discharge or dead)

3. ICU Admission [3 months]

   A patient is likely to be admitted to ICU during intervention period

Secondary Outcome Measures

1. Il-6 and CRP Levels [3 months]

   Il-6 and CRP Levels during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. M. Djamil General Hospital	Padang	West Sumatera	Indonesia	25176

Sponsors and Collaborators

• Universitas Sriwijaya
• M. Djamil General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sari Bema Ramdika, Ms, Universitas Sriwijaya
• ClinicalTrials.gov Identifier: NCT06004375
• Other Study ID Numbers: ID
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sari Bema Ramdika, Ms, Universitas Sriwijaya: COVID-19; Oral Nutrition Supplement
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 22, 2023