Arginine Replacement Therapy in COVID-19

NCT05855330 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000055722025P010543
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in mitochondrial function

  Complex-IV activity changes will be measured to estimate mitochondrial function before and after administration for L-arginine

  Baseline and day 5

Secondary Outcomes (5)

• Change in amino acids

  Baseline and day 5

• Change in the arginase-1 activity/concentration

  Baseline and day 5

• Change in myeloid-derived suppressor cells (MDSC-source of arginase-1)

  Baseline and day 5

• Change in the level of cytokines (IL-6)

  Baseline and day 5

• Change on secretory phospholipase (sPLA2).

  Baseline and day 5

Study Arms (3)

L-arginine loading dose + standard dose

ACTIVE COMPARATOR

L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID).

Drug: Arginine Hydrochloride

Standard dose

ACTIVE COMPARATOR

Standard dose (100mg/kg IV TID).

Drug: Arginine Hydrochloride

Low dose

ACTIVE COMPARATOR

Low dose (25mg/kg IV TID).

Drug: Arginine Hydrochloride

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.

Also known as: L-arginine

L-arginine loading dose + standard dose; Low dose; Standard dose

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 may not qualify 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
• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

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

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Arginine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Claudia R. Morris, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia R. Morris, MD

CONTACT

404 727-5500; claudia.r.morris@emory.edu

Dunia Hatabah, MD

CONTACT

470-6626706; dunia.hatabah@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 11, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data are available for at least 5 years after publication of primary results.
• Access Criteria: Data are available for at least 5 years, available upon request from PI, directed to claudia.r.morris@emory.edu

Locations

US (1)