Essential Amino Acid Supplementation in Older Adult COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Modulation of Muscle Protein Metabolism by Essential Amino Acids

NCT01890369

Old Age

UNKNOWN NA

Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)

NCT00502372

Pressure Ulcers

TERMINATED PHASE1

Impact of Amino Acids to Enhance Anabolism After Home-based Exercise

NCT04850820

Amino Acids, Essential Metabolism Exercise

COMPLETED NA

Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

NCT04858412

Alcoholic Liver Disease COVID 19 Pneumonia

RECRUITING NA

Effect of Amino Acid on Muscle Damage

NCT03319147

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EAA - non-vaccinated

18 g/day

Group Type EXPERIMENTAL

Essential amino acids

Intervention Type DRUG

Dietary Supplement

Placebo - non-vaccinated

18 g/day

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Control

EAA - vaccinated

18 g/day

Group Type EXPERIMENTAL

Essential amino acids

Intervention Type DRUG

Dietary Supplement

Placebo - vaccinated

18 g/day

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Essential amino acids

Dietary Supplement

Intervention Type DRUG

Maltodextrin

Control

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EAA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No