Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Phase 2

Withdrawn

• Conditions: Covid19

• Registration Number: NCT04816071
• Lead Sponsor: University of Arkansas

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.

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.

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-25
• Status Verified: 2021-05
• Study Start: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in symptoms	12 weeks	Decrease in EAA group symptom score compared to placebo by 25%