Effectiveness of Ammonium Chloride in Reducing Viral Load

NCT07254052 | Completed

• 1 other identifier: Sotiria GH 14328/17-05-2025
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

RNA Virus Infections; Viral Infection COVID-19; Influenza A and B

Keywords

ammonium chloride; influenza; SARS-CoV-2; RNA virus infections; virus clearance

Outcome Measures

Primary Outcomes (1)

• Change in viral load measured by RT-PCR Ct values

  Change in viral load was assessed through real-time PCR (RT-PCR) cycle threshold (Ct) values for SARS-CoV-2 or influenza A/B from nasopharyngeal swabs. Measurements were performed at three predefined time points (Day 1, Day 3-5, and Day 10-12). Viral load reduction was defined as an increase in Ct values over time. Samples were processed at the Department of Pharmacy, National and Kapodistrian University of Athens.

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

Secondary Outcomes (6)

• Duration of symptoms

  Up to Day 30 after diagnosis

• Hospitalization rate (outpatients only)

  Up to Day 30

• Need for oxygen administration

  Up to Day 30

• ICU admission

  Up to Day 30

• Intubation

  Up to Day 30

Study Arms (2)

ACF receiving participants

Participants assigned to this group received the sustained-release ammonium chloride formulation (ACF), containing 500 mg ammonium chloride and 2,000 IU vitamin D per capsule. One capsule was administered orally every 12 hours for 10 consecutive days, starting on Day 1. Both inpatients and outpatients with mild or moderate COVID-19 or seasonal influenza infection were included. The intervention aimed to evaluate the effect of ammonium chloride on viral load reduction and clinical outcomes compared to the control group. Randomization and double-blinding were maintained throughout the study.

Control Group (VDF receiving participants)

Participants assigned to this group received the control formulation consisting of sustained-release tablets containing 2,000 IU vitamin D and identical excipients, but no ammonium chloride. One capsule was administered orally every 12 hours for 10 consecutive days, starting on Day 1. Both inpatients and outpatients with mild or moderate COVID-19 or seasonal influenza infection were included. This control arm was used to compare changes in viral load dynamics and clinical outcomes against the intervention group. Randomization and double-blinding were maintained throughout the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with mild or moderate COVID-19 or seasonal influenza infection were recruited at the Outpatients Clinic and the Emergency Department of Sotiria General Hospital for Chest Diseases in Athens, Greece and at "En Ygeia" outpatient clinic. Both inpatients and outpatients were eligible. All participants had a laboratory-confirmed diagnosis by rapid antigen testing and were enrolled within 3-5 days of symptom onset. Patients with severe disease, organ transplantation, pregnancy, or frailty score ≥5 were excluded. A total of 32 participants completed the study procedures.

You may qualify if:

• Adults ≥ 18 years.
• Positive rapid test for Sars-CoV-2 19 or influenza (performed at the Outpatients Clinic or the Emergency Department).
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Third Department of Medicine, Sotiria General Hospital: collaborator

Study Sites (2)

En Ygeia Clinic

Athens, 11524, Greece

Location

Sotiria General Hospital

Athens, Greece

Location

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MeSH Terms

Conditions

RNA Virus Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: September 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)