Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:
• Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
• Age 3 years - 21 years of age
Locations
United States
Georgia
Children's Healthcare of Atlanta (CHOA), Arthur M. Blank
RECRUITING
Atlanta
Contact Information
Primary
Claudia R. Morris, MD
claudia.r.morris@emory.edu
404 727-5500
Backup
Dunia Hatabah, MD
dunia.hatabah@emory.edu
470-6626706
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2027-06
Participants
Target number of participants: 21
Treatments
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).
Sponsors
Leads: Emory University