Health TrialsbyHealthPanel

Arginine Replacement Therapy in COVID-19

ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-21
SponsorEmory University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection

Age 3 years - 21 years of age

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: L-arginine loading dose + standard doseActive comparator 1 intervention
Group B: Standard doseActive comparator 1 intervention
Group C: Low doseActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline and day 5

Secondary outcomes

1

Change in amino acids

arginine (ARG) ornithine (ORN) and citrulline (CIT) will be measured before and after administration for L-arginine

Time frame
Baseline and day 5
2

Change in the arginase-1 activity/concentration

arginase-1 will be measured before and after administration for L-arginine

Time frame
Baseline and day 5
3

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

Myeloid-derived suppressor cells (MDSC) producing arginase-1 will be measured in the peripheral blood before and after administration of L-arginine

Time frame
Baseline and day 5
4

Change in the level of cytokines (IL-6)

Cytokines are biomarkers for inflammation. Cell supernatants will be collected and analyzed for different cytokines.

Time frame
Baseline and day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Source ClinicalTrials.gov
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