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Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

University of Arkansas logo

University of Arkansas

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Covid19

Treatments

Dietary Supplement: Maltodextrin
Drug: Essential amino acids

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 4 patient groups, including a placebo group

EAA - non-vaccinated
Experimental group
Description:
18 g/day
Treatment:
Drug: Essential amino acids
Placebo - non-vaccinated
Placebo Comparator group
Description:
18 g/day
Treatment:
Dietary Supplement: Maltodextrin
EAA - vaccinated
Experimental group
Description:
18 g/day
Treatment:
Drug: Essential amino acids
Placebo - vaccinated
Placebo Comparator group
Description:
18 g/day
Treatment:
Dietary Supplement: Maltodextrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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