COVID-19Phase 3NCT06004375
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
A Phase 3 study testing Neomune in people with COVID-19, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Neomune
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2021to 30 May 2023
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients confirmed positive for COVID-19
- Age over 17 years
- The patient can take food orally
Who cannot join
- Patients with restricted fluid intake
- Patients who cannot take food orally
- suffering from diabetes mellitus and kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- COVID-19
- Being tested
- Neomune
- Keywords
- COVID-19, Oral Nutrition 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.
NeomuneDietary supplement
Neomune containing 4.8 g arginine and 2 g glutamine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Neomune |
| control group | Active comparator | the control was administered with a High-Calorie High-Protein diet + ONS hospital standard. Receives: Dietary Supplement: Neomune |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay
length of stay of patients in hospital
Measured: 3 months
Outcome
Outcome Measures of patients (discharge or dead)
Measured: 3 months
ICU Admission
A patient is likely to be admitted to ICU during intervention period
Measured: 3 months
Secondary outcomes (1)
Il-6 and CRP Levels
Il-6 and CRP Levels during hospitalization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 May 2021
- Primary completion30 May 2023
- Study completion30 May 2023
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- M. Djamil General Hospital
- Responsible party
- Principal investigator, Sari Bema Ramdika, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004375
- Sponsor's protocol ID
- ID
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 22 Aug 2023
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06004375
- Acronym / sponsor ID
- ID
- Conditions
- COVID-19
- Keywords
- COVID-19, Oral Nutrition Supplement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Collaborators
- M. Djamil General Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 22 Aug 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: NeomuneThe 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 |
| control group | Active comparator | Dietary Supplement: Neomunethe control was administered with a High-Calorie High-Protein diet + ONS hospital standard. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients confirmed positive for COVID-19
- Age over 17 years
- The patient can take food orally
Key exclusion criteria (3 listed)
- Patients with restricted fluid intake
- Patients who cannot take food orally
- suffering from diabetes mellitus and kidney failure
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 |
|---|---|---|
| NeomuneNeomune containing 4.8 g arginine and 2 g glutamine | Dietary supplement | control group, intervention group |
Primary outcome
length of stay
Time frame: 3 months
length of stay of patients in hospital
Outcome
Time frame: 3 months
Outcome Measures of patients (discharge or dead)
ICU Admission
Time frame: 3 months
A patient is likely to be admitted to ICU during intervention period
1 secondary outcome
Il-6 and CRP Levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neomune in people with COVID-19, run by Universitas Sriwijaya at 1 site in Indonesia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay (time frame: 3 months). 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 22 Aug 2023.