COVID-19 study: Arginine Hydrochloride
Official title Arginine Replacement Therapy in COVID-19
ClinicalTrials.gov ID: NCT05855330
What this study is testing
What is Arginine Hydrochloride?
An investigational intravenous infusion being studied for COVID‑19 in children.
Also referred to as L‑arginine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if arginine improves mitochondria function in kids with COVID‑19.
- Who it's for
- Children who have COVID‑19.
- What's involved
- Participants will receive one of three arginine doses, taken three times a day for up to five days or until they are discharged from the hospital.
- Time commitment
- The treatment lasts up to five days, with daily doses and any required hospital visits.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 21
You may be able to join if
- Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
- Age 3 years - 21 years of age
You likely can't join if
- Severe hepatic dysfunction: ALT\> 6 x Upper limit of normal
- Renal dysfunction: Creatinine \> 1.5 x upper limit of normal or on dialysis
- Acute Stroke
- Pregnancy
- Allergy to arginine
- Past history of severe cardiac disease or significant cardiac surgery [minor procedures like ventricular septal defect (VSD) repair are not an...
See the full eligibility criteria
- Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
- Age 3 years - 21 years of age
- Severe hepatic dysfunction: ALT\> 6 x Upper limit of normal
- Renal dysfunction: Creatinine \> 1.5 x upper limit of normal or on dialysis
- Acute Stroke
- Pregnancy
- Allergy to arginine
- Past history of severe cardiac disease or significant cardiac surgery [minor procedures like ventricular septal defect (VSD) repair are not an exclusion]
- History of significant pulmonary disease [Cystic Fibrosis, sickle cell disease (SCD)]
- History of organ transplant
- History of metabolic or mitochondrial disease (including Diabetes)
- History of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury)
- History of ventriculoperitoneal (VP) shunt or hydrocephalus
- PI discretion that the patient is not an ideal candidate for the study
- History of HIV of immune compromise
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.