Expanded Clinical Use of Nasalferon in COVID-19

Not Applicable

• Conditions: COVID-19; SARS-CoV-2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Nidovirales Infections; Betacoronavirus

• Registration Number: RPCEC00000396
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-10
• Study Completion: 2022-01-31
• Results First Posted: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Low risk suspect, mild symptomatic, with positive antigen test.
2. Confirmed low risk, asymptomatic and mild symptomatic, with positive PCR.
3. Voluntariness of the patient or legal representative.

Exclusion Criteria

1. Individuals confirmed COVID-19 and classified as medium and high risk.
2. Individuals with hypersensitivity to thiomersal (thimerosal).
3. Individuals with hypersensitivity to interferon alpha

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events associated with treatment (Yes or No, Description of adverse events). Measurement time: daily during the patient's treatment time (10 days).

Secondary Outcome Measures

Name	Time	Method
1. Intensity of the adverse event (CLasified as mild, moderate or severe). Measurement time: daily during the patient's treatment times (10 days).<br>2. Causation of the adverse event (Classified as definitive, probable, possible and doubtful). Measurement time: daily during the patient's treatment times (10 days).<br>3. Severity of the adverse event (classified as serious and non-serious). Measurement time: daily during the patient's treatment times (10 days).