CompletedNot Applicable

Effectiveness of Ammonium Chloride in Reducing Viral Load

Greece32 participantsStarted 2024-09-01

Plain-language summary

This is a prospective, double-blind, randomized, comparative effectiveness pilot study evaluating the effect of a sustained-release ammonium chloride formulation (ACF) on viral load dynamics in adult patients with mild or moderate COVID-19 or seasonal influenza infection. Eligible participants are randomly assigned in a 1:1 ratio to receive either ACF (ammonium chloride with vitamin D) or a control formulation (vitamin D only) twice daily for 10 consecutive days. The primary objective is to assess the reduction of viral load measured by RT-PCR cycle threshold (Ct) values at baseline, Day 3-5, and Day 10-12. Secondary objectives include the duration and severity of symptoms, incidence of hospitalization, oxygen supplementation, ICU admission, and mortality. The study is conducted in both inpatient and outpatient settings at Sotiria General Hospital for Chest Diseases, Athens, Greece as well as at the outpatient clinic "En Ygeia". All viral load analyses are performed at the Department of Pharmacy, National and Kapodistrian University of Athens. A total of 32 participants were enrolled. This study aims to generate early clinical evidence regarding the antiviral effectiveness of ACF as an adjunct strategy in respiratory RNA virus infections.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥ 18 years. * Positive rapid test for Sars-CoV-2 19 or influenza (performed at the Outpatients Clinic or the Emergency Department). * Informed consent. Exclusion Criteria: * Age \< 18 years. * Pregnancy, and/or lactation. * Denial of Informed Consent. * Known allergy to ammonium chloride or to any of the ACF, or VDF excipients. * Organ transplantation. * Frailty score ≥ 5.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in viral load measured by RT-PCR Ct values

Timeframe: Baseline (Day 1), Day 3-5, Day 10-12

Trial details

NCT IDNCT07254052

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More RNA Virus Infections trials