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Amino Acid

Arginine Therapy for COVID-19 (ART-COVID19 Trial)

Phase 2
Recruiting
Led By Claudia R. Morris, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 3 years - 21 years of age
Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
Must not have
History of HIV of immune compromise
Renal dysfunction: Creatinine > 1.5 x upper limit of normal or on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 5
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at whether giving children with COVID-19 doses of arginine can improve their mitochondria function. Patients will get different doses for 5 days or until discharge.

Who is the study for?
This trial is for children and young adults aged 3 to 21 who are hospitalized with COVID-19. They must not have severe heart issues, kidney dysfunction, liver problems, metabolic diseases like diabetes, or compromised immune systems. Pregnant individuals or those with allergies to arginine can't participate.
What is being tested?
The study tests if different doses of arginine hydrochloride given three times daily can improve mitochondrial function in pediatric patients with COVID-19. The treatment lasts five days or until discharge.
What are the potential side effects?
While the specific side effects of arginine therapy in this context aren't detailed here, common reactions may include gastrointestinal discomfort, changes in blood pressure, electrolyte imbalances, and allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 and 21 years old.
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I am hospitalized due to COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of HIV or a weakened immune system.
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My kidney function is impaired, with creatinine levels above normal or I am on dialysis.
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I have had an organ transplant.
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I have recently had a stroke.
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I have a history of serious lung disease like Cystic Fibrosis or sickle cell.
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My liver function tests are very high.
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I have a history of a metabolic or mitochondrial disease, including diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in mitochondrial function
Secondary study objectives
Change in amino acids
Change in myeloid-derived suppressor cells (MDSC-source of arginase-1)
Change in the arginase-1 activity/concentration
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: L-arginine loading dose + standard doseActive Control1 Intervention
L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID).
Group II: Standard doseActive Control1 Intervention
Standard dose (100mg/kg IV TID).
Group III: Low doseActive Control1 Intervention
Low dose (25mg/kg IV TID).

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,463 Total Patients Enrolled
Claudia R. Morris, MDPrincipal InvestigatorEmory University

Media Library

Arginine Hydrochloride (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT05855330 — Phase 2
Coronavirus Research Study Groups: L-arginine loading dose + standard dose, Standard dose, Low dose
Coronavirus Clinical Trial 2023: Arginine Hydrochloride Highlights & Side Effects. Trial Name: NCT05855330 — Phase 2
Arginine Hydrochloride (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05855330 — Phase 2
~5 spots leftby Jun 2025
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