Effectiveness of Ammonium Chloride in Reducing Viral Load (ACTEarly)

November 19, 2025 updated by: Nikolaos Drakoulis, MD, National and Kapodistrian University of Athens

Effectiveness of a Sustained-release Ammonium Chloride Formulation in Reducing the Viral Load of Patients With COVID-19 or Influenza

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective, double-blind, randomized, comparative effectiveness pilot clinical study designed to evaluate the antiviral effect of a sustained-release ammonium chloride formulation (ACF) in adult patients with mild or moderate SARS-CoV-2 or seasonal influenza infection. Respiratory viral infections remain a major global health burden, and safe, accessible adjunct therapies are needed to complement existing public health measures and vaccination strategies.

Eligible participants are adults (≥18 years) with a positive rapid test for SARS-CoV-2 or influenza A/B, recruited at the Outpatients Clinic or Emergency Department of Sotiria General Hospital for Chest Diseases and at "En Ygeia" outpatient clinic. Participants are randomized in a 1:1 ratio to receive either:

  1. ACF (nutritional supplement): sustained-release ammonium chloride formulation with vitamin D, one capsule every 12 hours for 10 days
  2. VDF (control): matched sustained-release placebo formulation containing only vitamin D, one capsule every 12 hours for 10 days.

Both inpatients and outpatients are included. Exclusion criteria are: age <18 years, pregnancy or lactation, denial of informed consent, known allergy to study components, organ transplantation, and frailty score ≥5. Participants may discontinue the study in cases of intolerance, non-compliance, or withdrawal of consent.

The primary endpoint is the reduction of viral load, assessed through RT-PCR cycle threshold (Ct) values obtained at baseline (Day 1), Day 3-5, and Day 10-12.

Secondary endpoints include:

  • Duration and severity of symptoms for 30 days
  • Incidence of hospitalization (for outpatients)
  • Need for oxygen supplementation
  • ICU admission
  • Intubation
  • Death. All RT-PCR testing for SARS-CoV-2 and influenza A/B were performed at the Department of Pharmacy, National and Kapodistrian University of Athens. The study employs standardized sampling, nucleic acid extraction, and real-time PCR quantification with certified reference materials.

Statistical analysis compared Ct values across timepoints within and between groups. Mean percentage change in Ct values was compared using appropriate parametric or non-parametric tests, with additional analyses for secondary outcomes. The final sample size was 32 patients.

This pilot trial aims to provide early clinical evidence regarding the potential antiviral effectiveness of ammonium chloride in the context of mild respiratory viral infections, contributing to the design of larger confirmatory studies.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11524
        • En Ygeia Clinic
      • Athens, Greece
        • Sotiria General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in viral load measured by RT-PCR Ct values
Time Frame: Baseline (Day 1), Day 3-5, Day 10-12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of symptoms
Time Frame: Up to Day 30 after diagnosis
Duration of respiratory and systemic symptoms was recorded for 30 days after diagnosis. Data were collected through patient interviews and medical record review.
Up to Day 30 after diagnosis
Hospitalization rate (outpatients only)
Time Frame: Up to Day 30
Number of outpatient participants requiring hospitalization within 30 days of diagnosis.
Up to Day 30
Need for oxygen administration
Time Frame: Up to Day 30
Number of participants requiring oxygen therapy during follow-up.
Up to Day 30
ICU admission
Time Frame: Up to Day 30
Number of participants admitted to the ICU for respiratory deterioration.
Up to Day 30
Intubation
Time Frame: Up to Day 30
Number of participants requiring endotracheal intubation.
Up to Day 30
Mortality
Time Frame: Up to Day 30
Number of deaths from any cause during the 30-day follow-up period.
Up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Collaborators

Third Department of Medicine, Sotiria General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sotiria GH 14328/17-05-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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