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Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Sponsor
University of Arkansas (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04816071
Collaborator
(none)
0
Enrollment
1
Location
4
Arms
10
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Essential amino acids
  • Dietary Supplement: Maltodextrin
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in symptoms [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    • Principal Investigator: Gohar Azhar, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT04816071
    Other Study ID Numbers:
    • 261678
    First Posted:
    Mar 25, 2021
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Arkansas
    Amino acid supplement
    Dietary supplement
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 7, 2021