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Intramuscular Peramivir for the Treatment of Uncomplicated Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00486980
Recruitment Status : Withdrawn (This study was withdrawn for administrative reasons. The dose ranging plan for the program was revised".)
First Posted : June 15, 2007
Last Update Posted : January 30, 2008
Information provided by:
BioCryst Pharmaceuticals

Brief Summary:
This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.

Condition or disease Intervention/treatment Phase
Influenza Drug: Peramivir 150mg Drug: Peramivir 300mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Peramivir

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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
Layout table for additonal information Identifier: NCT00486980    
Other Study ID Numbers: BCX1812-312
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008
Keywords provided by BioCryst Pharmaceuticals:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action