RECRUITING

Arginine Replacement Therapy in COVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-08

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05855330

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.

Ages Eligible for Study:3 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Claudia R. Morris, MD

CONTACT

404 727-5500

claudia.r.morris@emory.edu

Dunia Hatabah, MD

CONTACT

470-6626706

dunia.hatabah@emory.edu

Principal Investigator

Claudia R. Morris, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Children's Healthcare of Atlanta (CHOA), Arthur M. Blank

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Claudia R. Morris, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

COVID-19