Effectiveness of a Sustained-release Ammonium Chloride Formulation in Reducing the Viral Load of Patients With COVID-19 or Influenza
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in viral load measured by RT-PCR Ct values
Study Overview
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.
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:
- ACF (nutritional supplement): sustained-release ammonium chloride formulation with vitamin D, one capsule every 12 hours for 10 days
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Mortality(Up to Day 30)
Investigators
Nikolaos Drakoulis, MD
Professor of Clinical Pharmacology
National and Kapodistrian University of Athens