Arginine Replacement Therapy in COVID-19

Description

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.

Conditions

COVID-19

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Study Overview

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Study Details

Study overview

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.

Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19

Arginine Replacement Therapy in COVID-19

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta (CHOA), Arthur M. Blank, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

3 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Claudia R. Morris, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2027-06