asalferon in ARI

Phase 2

• Conditions: Acute respiratory infection (ARI); Infections; Respiratory Tract Diseases; Respiratory Tract Infections

• Registration Number: RPCEC00000407
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-29
• Study Completion: 2022-12-17
• Results First Posted: 2023-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

1.- Clinical diagnosis of AKI with mild symptoms (non-sustained fever = 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body aches, malaise, diarrhea and/or vomiting. White nasal discharge (clear ) or transparent Radiology (Rx) normal Oxygen saturation greater than 95%).
2.- Age between 19 and 80 years, regardless of sex or skin color.
3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms.
4.- Willingness of the patient to participate in the trial.

Exclusion Criteria

1.- Individuals under 19 years of age and over 80.
2.- Individuals with suspected clinical diagnosis of AKI with bacterial etiology.
3.- Individual with a clinical diagnosis of AKI with mild symptoms, without having started treatment within 48 hours after the onset of symptoms.
4.- Individuals with symptoms of AKI in moderate, severe or critical clinical classification.
5.- Individuals with chronic decompensated disease.
6.- Treatment with immunosuppressants in the last month prior to inclusion.
7.- Ongoing treatment, for any reason, with any formulation of IFN alpha.
8.- Active use of some other drug or substance intranasally.
9.- Patient diagnosed with Myasthenia Gravis.
10.- Administration of an investigational drug in the 30 days prior to inclusion in the study.
11.- Individuals with hypersensitivity to thiomersal (thimerosal).
12.- Individuals with hypersensitivity to interferon alfa.
13.- Evident mental inability to give consent and act accordingly with the study.
14.- Pregnancy, puerperium or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Recovery (Recovered patient: PCR negative for AKI of viral aetiology and absence of clinical symptoms of AKI. Non-recovered patient: PCR positive for AKI of viral aetiology or presence of clinical symptoms of AKI). Measurement time: 8th day after starting treatment.

Secondary Outcome Measures

Name	Time	Method
1.- Clinical response (disappearance of clinical respiratory symptoms). Measurement time: Daily during the treatment time of the patient.<br>2.- Virological response (PCR negative for ARI of viral aetiology). Measurement time: on the 8th and 11th day of starting treatment.<br>3.- Proportion of recovered patients (Quotient number of patients recovered/number of patients included). Measurement time: 8th and 11th day of starting treatment.<br>