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One shot to beat the flu? new drug peramivir tested in large trial

NCT ID NCT00486980

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single injection of peramivir can safely treat uncomplicated flu in adults. Participants receive either 150 mg, 300 mg of peramivir, or a placebo, and researchers measure how quickly symptoms improve. The goal is to see if this antiviral shot offers a fast, effective option for flu relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
peramivir
What this could lead to
If effective, peramivir could offer a convenient single-dose treatment for flu, reducing symptom duration and severity.
What could go wrong
This is a phase 3 trial, but results may not confirm benefit over placebo, and side effects or lack of efficacy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and non-pregnant female subjects age ≥18 years * A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result. * Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. For subjects with a positive RAT at the time of screening, a subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of screening * Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe) * Presence of at least one constitutional symptom (myalgia \[muscle aches\], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe) * Onset of symptoms no more than 48 hours before presentation for screening * Written informed consent Exclusion Criteria: * Women who are pregnant or breast-feeding * Presence of clinically significant signs of acute respiratory distress * History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma * History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months * History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \<50 mL/min) * Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics * Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy * Current treatment for active viral hepatitis C * Presence of known HIV infection with a CD4 count \<350 cell/mm3 * Current therapy with oral warfarin or other systemic anticoagulant * Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening * Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days * History of alcohol abuse or drug addiction within 1 year prior to admission in the study * Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study * Participation in a study of any investigational drug within the last 30 days

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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