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Famotidine + Cetirizine + LDN for Long COVID

Phase 3
Recruiting
Led By Tiffany Walker, MD
Research Sponsored by Emory University
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 12 weeks post-intervention
Awards & highlights

Study Summary

This trial seeks to understand the effects of long-COVID on patients and evaluate possible treatments.

Who is the study for?
Adults over 18 in Georgia with long COVID symptoms for at least 12 weeks post-positive SARS-CoV-2 test, able to swallow capsules and use the internet. Must not be pregnant, planning pregnancy, or have unstable medical conditions. Cannot be on certain medications or treatments for COVID-19 or opioid addiction.Check my eligibility
What is being tested?
The trial is testing Famotidine, Cetirizine, and Low-dose Naltrexone (LDN) against placebos to see if they help with long COVID symptoms. It's a randomized study where patients won't know if they're getting the real treatment or a placebo.See study design
What are the potential side effects?
Possible side effects may include digestive issues from Famotidine; drowsiness or dry mouth from Cetirizine; and nausea, headache, or insomnia from LDN. Reactions vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement rating
Interest score
Number of participants satisfied with their opportunities to interact with study staff
+9 more
Secondary outcome measures
Adverse events (AEs) incidence
Number of discontinuations or temporary suspensions of IP
Proportion of Lost to Follow Up (LFUP)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HRA Treatment ArmExperimental Treatment2 Interventions
Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily.
Group II: Placebo ArmPlacebo Group2 Interventions
The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Famotidine
2005
Completed Phase 4
~1700
Cetirizine
2020
Completed Phase 4
~5300

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,621 Total Patients Enrolled
21 Trials studying COVID-19
493,732 Patients Enrolled for COVID-19
CURE Drug Repurposing Collaboratory (CDRC)UNKNOWN
Tiffany Walker, MDPrincipal InvestigatorEmory University

Media Library

HRA Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT05946551 — Phase 3
COVID-19 Research Study Groups: Placebo Arm, HRA Treatment Arm
COVID-19 Clinical Trial 2023: HRA Treatment Arm Highlights & Side Effects. Trial Name: NCT05946551 — Phase 3
HRA Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05946551 — Phase 3

Frequently Asked Questions

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

Is the LDN Treatment Arm a reliable course of action for people?

"LDN Treatment Arm has been evaluated to have a safety rating of 3 due to the presence of efficacy data and multiple rounds of supporting security reviews from Phase 3 trials."

Answered by AI

Are there any opportunities to enroll in this trial at present?

"Information hosted on clinicaltrials.gov reveals that this study is not actively recruiting participants, despite being recently updated in July of 2023. However, there are 809 other trials which currently welcome enrolment applications from interested parties."

Answered by AI

What is the ultimate purpose of this experiment?

"This trial will assess its efficacy after a 12-week post-intervention period, taking into account the participants who struggled to adhere to the prescribed medication schedule (measured by proportion of drug adherence), as well as serious unexpected suspected adverse reactions and total adverse events."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Emory University Hospital Midtown
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Emory University Hospital Midtown: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial
Tiffany A Walker 2024. "Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05946551.
All > Covid 19 > Coronavirus
~24 spots leftby Oct 2024
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