Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Essential amino acids
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EAA - non-vaccinated<br>18 g/day | Drug: Essential amino acids<br>* Dietary Supplement<br>* Other names: EAA;|
| Placebo Comparator: Placebo - non-vaccinated<br>18 g/day | Dietary Supplement: Maltodextrin<br>* Control<br>|
| Experimental: EAA - vaccinated<br>18 g/day | Drug: Essential amino acids<br>* Dietary Supplement<br>* Other names: EAA;|
| Placebo Comparator: Placebo - vaccinated<br>18 g/day | Dietary Supplement: Maltodextrin<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in symptoms | Decrease in EAA group symptom score compared to placebo by 25% | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amino acid supplement, Dietary supplement