Back to resultsEssential Amino Acid Supplementation in Older Adult COVID-19 Patients
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Essential amino acids
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Amino acid supplement, Dietary supplement
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
EAA - non-vaccinated
Placebo - non-vaccinated
EAA - vaccinated
Placebo - vaccinated
Arm Description
18 g/day
18 g/day
18 g/day
18 g/day
Outcomes
Primary Outcome Measures
Improvement in symptoms
Decrease in EAA group symptom score compared to placebo by 25%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04816071
Brief Title
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Official Title
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI no longer wanted to do the study
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Amino acid supplement, Dietary supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EAA - non-vaccinated
Arm Type
Experimental
Arm Description
18 g/day
Arm Title
Placebo - non-vaccinated
Arm Type
Placebo Comparator
Arm Description
18 g/day
Arm Title
EAA - vaccinated
Arm Type
Experimental
Arm Description
18 g/day
Arm Title
Placebo - vaccinated
Arm Type
Placebo Comparator
Arm Description
18 g/day
Intervention Type
Drug
Intervention Name(s)
Essential amino acids
Other Intervention Name(s)
EAA
Intervention Description
Dietary Supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Control
Primary Outcome Measure Information:
Title
Improvement in symptoms
Description
Decrease in EAA group symptom score compared to placebo by 25%
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gohar Azhar, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
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