Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EAA - non-vaccinated 		18 g/day
  • Drug: Essential amino acids
    Dietary Supplement
    Other names:
    • EAA
Placebo Comparator
Placebo - non-vaccinated 		18 g/day
  • Dietary Supplement: Maltodextrin
    Control
Experimental
EAA - vaccinated 		18 g/day
  • Drug: Essential amino acids
    Dietary Supplement
    Other names:
    • EAA
Placebo Comparator
Placebo - vaccinated 		18 g/day
  • Dietary Supplement: Maltodextrin
    Control

Recruiting Locations

More Details

NCT ID
NCT04816071
Status
Withdrawn
Sponsor
University of Arkansas

Detailed Description

In people who have been exposed to COVID-19 and have been tested (positive or negative) with no to mild symptoms, the study team will administer a treatment of essential amino acids (EAA). The study team will examine if this treatment compared to placebo will reduce the development, length and the severity of symptoms. Participants will consume the treatment or placebo for 4 weeks, and will complete symptom surveys, as well as pre- and post-assessments. Individuals who receive a COVID vaccination will continue to complete symptom surveys for 1 week and take the essential amino acid supplementation for 2 weeks following a vaccination.