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Sodium Citrate for Long COVID Syndrome

Phase 2

Recruiting

Led By Brent A. Senior, MD, FACS, FARS

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing the use of a nasal spray containing sodium citrate to help improve the sense of smell in people who have lost it after having COVID-19. The researchers want to find out if

Who is the study for?

This trial is for individuals who have lost their sense of smell after having COVID-19 and are still experiencing this issue. Participants will use a nasal spray and undergo smell training twice daily for 12 weeks to see if it helps recover their sense of smell.Check my eligibility

What is being tested?

The study tests whether adding sodium citrate nasal spray to regular olfactory (smell) retraining can improve the sense of smell in people with long-term loss due to COVID-19, compared to using just normal saline spray with the same training.See study design

What are the potential side effects?

Potential side effects may include discomfort or irritation in the nose from using the nasal sprays. Since this is a pilot study, part of its purpose is also to monitor any adverse events related to the use of sodium citrate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence Rate Distribution

Proportion of Participants Who Report Minor or Severe Adverse Events

The Number of Eligible Patients

+2 more

Secondary outcome measures

Change in Sniffin' Sticks Score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sodium CitrateExperimental Treatment2 Interventions

The Sodium Citrate arm will use sodium citrate nasal spray and olfactory training twice a day for 12 weeks.

Group II: Normal SalinePlacebo Group2 Interventions

The Normal Saline arm will use normal saline nasal spray and olfactory training twice a day for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium Citrate

2022

Completed Phase 4

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,765 Total Patients Enrolled

Brent A. Senior, MD, FACS, FARSPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this trial is presently seeking individuals to participate. The study was initially published on December 1st, 2023 and was most recently updated on January 10th, 2024. A total of 60 patients are being sought for enrollment at a single site."

Answered by AI

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"Indeed, according to the information on clinicaltrials.gov, this study is currently in the process of recruiting participants. The trial was initially posted on December 1st, 2023 and recently updated on January 10th, 2024. The research team aims to enroll a total of 60 patients at one designated site."

Answered by AI

Has the Food and Drug Administration granted approval for the use of Sodium Citrate?

"Based on the categorization of this trial as Phase 2, our team at Power rates the safety profile of Sodium Citrate as a 2. While there is existing data supporting its safety, there is currently no evidence to support its efficacy in this context."

Answered by AI