NCT06004375

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started May 2021

Longer than P75 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

August 19, 2023

Last Update Submit

August 19, 2023

Conditions

COVID-19

Keywords

COVID-19Oral Nutrition Supplement

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Il-6 and CRP Levels

    3 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.

Dietary Supplement: Neomune

Interventions

NeomuneDIETARY_SUPPLEMENT

Neomune containing 4.8 g arginine and 2 g glutamine

control groupintervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients confirmed positive for COVID-19
  • Age over 17 years
  • The patient can take food orally

You may not qualify if:

  • Patients with restricted fluid intake
  • Patients who cannot take food orally
  • suffering from diabetes mellitus and kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. M. Djamil General Hospital

Padang, West Sumatera, 25176, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

August 19, 2023

First Posted

August 22, 2023

Study Start

May 1, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)