Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Ainos

Status and phase: Completed; Phase 2

Conditions: Influenza A Virus Infection

Treatments: Other: maltose; Drug: Interferon-alpha; Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146535

QCR09025

Details and patient eligibility

About

This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.

Enrollment: 40 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fever >=38C
• one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of < 48 hours' duration
• body weight > 40 kg
• positive for influenza A (nasal swab rapid test)

Exclusion criteria

• pregnancy/lactation
• history of depression or psychiatric disorders
• history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
• use of immunosuppressive therapy
• HIV infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Interferon-alpha

Experimental group

Description:

Interferon-alpha 150 IU lozenges bid for 5 days

Treatment:

Drug: Oseltamivir

Drug: Interferon-alpha

maltose

Placebo Comparator group

Description:

maltose 200 mg maltose lozenges bid for 5 days

Treatment:

Drug: Oseltamivir

Other: maltose