Glycine Supplement for Severe COVID-19

NCT04443673 | Terminated DMC

• 1 other identifier: C40-20
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore whether a daily supplement of glycine, a substance that has antiinflammatory, cytoprotective, and endothelium-protecting effects, can improve mortality, as well as clinical and biochemical parameters, in patients with severe COVID-19 who initiate mechanical ventilatory support.

Conditions

COVID-19; SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia; ARDS, Human; Pneumonia, Viral

Keywords

Glycine; Aminoacetic Acid; Coronavirus Disease; COVID-19; Severe Acute Respiratory Syndrome; SARS

Outcome Measures

Primary Outcomes (1)

• Mortality

  Number of participants who die divided by number of subjects enrolled in the that study group.

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Secondary Outcomes (40)

• Days under mechanical ventilation

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

• PaO2/FiO2 ratio

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

• Arterial plasma lactate

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

• Serum IL-1β

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

• Serum IL-2

  From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Study Arms (2)

Glycine

EXPERIMENTAL

Along with habitual treatment for their severe condition, participants will receive 0.5 g/kg/day glycine by nasogastric tube, divided in four equal doses in a day, since their enrollment and until they are weaned from mechanical ventilator or die.

Dietary Supplement: Glycine

Control

NO INTERVENTION

Participants will receive the habitual treatment for their severe condition.

Interventions

Glycine DIETARY_SUPPLEMENT

Along with habitual treatment for their severe condition, participants will receive 0.5 g/kg/day glycine by nasogastric tube, divided in four equal doses in a day, since their enrollment and until they are weaned from mechanical ventilator or die.

Glycine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any age.
• Any sex.
• With COVID-19 confirmed (or awaiting confirmation) by PCR.
• With a clinical decision of initiation of mechanical ventilation or with \<48 h under mechanical ventilation.
• Informed consent signed by the participant's responsible.

You may not qualify if:

• Pregnant women.
• Already participating in another research protocol.
• Elimination Criteria:
• Voluntary hospital discharge or referenced to another institution.

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, 14080, Mexico

Location

Related Publications (31)

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  BACKGROUND

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  BACKGROUND

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• Vargas MH, Del-Razo-Rodriguez R, Lopez-Garcia A, Lezana-Fernandez JL, Chavez J, Furuya MEY, Marin-Santana JC. Effect of oral glycine on the clinical, spirometric and inflammatory status in subjects with cystic fibrosis: a pilot randomized trial. BMC Pulm Med. 2017 Dec 15;17(1):206. doi: 10.1186/s12890-017-0528-x.

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• Vargas MH, Chavez J, Del-Razo-Rodriguez R, Munoz-Perea C, Romo-Dominguez KJ, Baez-Saldana R, Rumbo-Nava U, Guerrero-Zuniga S. Lower Serum Magnesium Is Associated with Mortality in Severe COVID-19: A Secondary Analysis of a Randomized Trial. Biol Trace Elem Res. 2025 Nov;203(11):5987-5996. doi: 10.1007/s12011-025-04619-9. Epub 2025 Apr 15.

  PMID: 40234280 DERIVED

• Vargas MH, Chavez J, Del-Razo-Rodriguez R, Munoz-Perea C, Romo-Dominguez KJ, Baez-Saldana R, Rumbo-Nava U, Guerrero-Zuniga S. Glycine by enteral route does not improve major clinical outcomes in severe COVID-19: a randomized clinical pilot trial. Sci Rep. 2024 May 21;14(1):11566. doi: 10.1038/s41598-024-62321-7.

  PMID: 38773199 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Pneumonia, Viral

Interventions

Glycine

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mario H Vargas, MSc

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Controlled, randomized, two branches, clinical trial.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 23, 2020
• Study Start: June 15, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From publication of results in a scientific journal onward.
• Access Criteria: Reasonable request by E-mail (mhvargasb@yahoo.com.mx)

Locations

ME (1)