Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

NCT04816071 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 261678
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A 4-week treatment of essential amino acids or placebo to participants with: 1) negative COVID-19 test with exposure, or 2) positive COVID-19 test and no or mild symptoms. The study team will measure change in symptoms. Participants will complete symptom surveys for 4 weeks and once at 8 and 12 weeks as well as pre- and post-assessments.

Conditions

Covid19

Keywords

Amino acid supplement; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• Improvement in symptoms

  Decrease in EAA group symptom score compared to placebo by 25%

  12 weeks

Study Arms (4)

EAA - non-vaccinated

EXPERIMENTAL

18 g/day

Drug: Essential amino acids

Placebo - non-vaccinated

PLACEBO COMPARATOR

18 g/day

Dietary Supplement: Maltodextrin

EAA - vaccinated

EXPERIMENTAL

18 g/day

Drug: Essential amino acids

Placebo - vaccinated

PLACEBO COMPARATOR

18 g/day

Dietary Supplement: Maltodextrin

Interventions

Essential amino acids DRUG

Dietary Supplement

Also known as: EAA

EAA - non-vaccinated; EAA - vaccinated

Maltodextrin DIETARY_SUPPLEMENT

Control

Placebo - non-vaccinated; Placebo - vaccinated

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exposure to COVID-19 in the last 60 days with no symptoms, with a COVID negative test Close contact: within 6 feet of a COVID-19 positive person for more than a few minutes without wearing PPE, or having direct contact with infectious secretions without PPE
• Positive COVID-19 test with or without symptoms

You may not qualify if:

• COVID-19 positive hospitalized patient
• Patients who have symptoms of COVID but have not been tested.
• Unable to tolerate oral intake
• In hospice or palliative care
• Unstable medical or psychiatric condition
• Other criteria deemed acceptable by principle investigator

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Amino Acids, Essential; maltodextrin

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; Amino Acids, Peptides, and Proteins

Study Officials

• Gohar Azhar, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 3, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)