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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 5
Awards & highlights
ART-COVID19 Trial 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.Check my eligibility
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.See study design
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.
ART-COVID19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 21 years old.
Select...
I am hospitalized due to COVID-19.
ART-COVID19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mitochondrial function
Secondary outcome measures
Change in amino acids
Change in myeloid-derived suppressor cells (MDSC-source of arginase-1)
Change in the arginase-1 activity/concentration
+2 moreART-COVID19 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).
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,636 Total Patients Enrolled
21 Trials studying COVID-19
493,747 Patients Enrolled for COVID-19
Claudia R. Morris, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of HIV or a weakened immune system.My kidney function is impaired, with creatinine levels above normal or I am on dialysis.I have had an organ transplant.I am between 3 and 21 years old.I have recently had a stroke.I have not had severe heart disease or major heart surgery.You have a history of having a VP shunt or hydrocephalus.You are allergic to arginine.I have a history of serious lung disease like Cystic Fibrosis or sickle cell.My liver function tests are very high.I have a history of a metabolic or mitochondrial disease, including diabetes.I am hospitalized due to COVID-19.You have a history of severe brain injury causing major difficulties with thinking and moving.
Research Study Groups:
This trial has the following groups:- Group 1: L-arginine loading dose + standard dose
- Group 2: Standard dose
- Group 3: Low dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility criteria for this trial extend to people aged 35 and over?
"This medical research requires the enrolment of patients aged between 3 and 21 years old. Clinicialtrials.gov details 129 trials for minors, while there are 768 studies that require participants over 65 to be enrolled."
Answered by AI
Is this research program currently recruiting participants?
"The information on clinicaltrials.gov reveals that this research project is no longer seeking participants; the trial was initially posted in July 1st 2023 and modified most recently on May 9th 2023. Nevertheless, 877 other medical trials are actively recruiting at present."
Answered by AI
Do I qualify to partake in this trial?
"Eligible individuals must be between the ages of 3 and 21, with a confirmed diagnosis of COVID-19 to join this trial. The researchers are seeking approximately twenty one test subjects."
Answered by AI
What effects can be anticipated from an L-arginine loading dose combined with the recommended dosage?
"Following a Phase 2 trial which suggested some safety but no efficacy, our team has judged the L-arginine loading dose + standard dose to be of moderate risk - scoring it as a 2."
Answered by AI
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