Arginine Replacement Therapy in COVID-19

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05855330
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Arginine Hydrochloride — DRUG
    Arginine will be infused based on the manufacturer's instructions (R-Gene 10, Pfizer), over 30 minutes. However, rates may be slowed to over 60 minutes for patients experiencing symptoms of flushing, nausea, vomiting, or headache at the research team's discretion. Pediatric doses will be drawn up by the pharmacy.

Study Details

This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19. The study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.

Key Dates

Start date
Jan 8, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: L-arginine loading dose + standard dose
    L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID).
  • Active Comparator: Standard dose
    Standard dose (100mg/kg IV TID).
  • Active Comparator: Low dose
    Low dose (25mg/kg IV TID).

Primary Outcome Measure

Change in mitochondrial function [ Time Frame: Baseline and day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta (CHOA), Arthur M. BlankAtlantaGeorgia30322
Claudia R Morris, MD
[email protected]
404 727-5500
Caludia R Morris, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Children's Healthcare of Atlanta (CHOA), Arthur M. Blank· Atlanta, GA

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