NCT05618574CompletedPhase 2
Nitrite Supplementation in Long COVID Patients
Nitrite Supplementation to Mitigate Fatigability and Increase Function in Long COVID Patients
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo beverage. Both groups will receive physical therapy at the long COVID Clinic at VAPHS with therapeutic goals to improve strength, balance, inspiratory, and aerobic capabilities. Physical therapy will last for 2 weeks and include 2 or 3 sessions with a physical therapist a week depending on each individual's exercise tolerance. These sessions can take place on-site or at home (or a hybrid combination) All participants will undergo functional assessments and tissue assessments before and after the 14-day study intervention.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 14 Nov 2022
- Start date
- 1 Dec 2023
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05618574
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 17
- From 1 Dec 2023 to the primary completion date, 12 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to hold warfarin, novel oral anticoagulants (NOACs) or aspirin for 3 days prior to muscle biopsy, or to hold thienopyridine medications for 5 days prior to muscle biopsy
- Current use of organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors
- Chronic use of oral corticosteroids or medications that affect muscle function
- Unwilling to hold Viagra-like drugs (i.e. Viagra, Cialis, Levitra, other phosphodiesterase inhibitors)
Other illness
- Orthopedic or other chronic condition which limits physical activity or functional testing assessments
- End-stage disease
- Dementia or other reason unable to give informed consent
- Unstable psychiatric diagnosis
- Other clinically unstable medical condition as determined by the study physician
Lab values
- Anemia (hemoglobin \<11.0 g/dL in men or hemoglobin \<10.0 g/dL in women)
Other
- Blood pressure \<110/60 mmHg, either systolic or diastolic value which may affect participant safety during assessments will be at the discretion of the study physician
- Clinically significant alcohol intake or substance abuse
- Use of anti-bacterial mouthwash or antacids that confound the nitrate/nitrite/NO pathway.
- Suicidal ideations
- Involved in another greater than minimal risk study
Who the study is looking for
- Veterans with prior COVID-19, with residual symptoms of long COVID including increased fatigability.
- Inclusion limited to age 18 and over
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.