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Completed

NCT Number: NCT01546506

Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells

Rationale:

Classical antiviral therapies target viral proteins and are consequently subject to resistance. To counteract this limitation, alternative strategies have been developed that target cellular factors. We hypothesized that such an approach could also be useful to identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral diversity and because of the need to develop therapies against unpredictable viruses as recently underlined by the H1N1 pandemic. Gene-expression signature-based screening identified broadly effective influenza A antivirals. Midodrine showed great results in inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

The main objective of the study is to assess the efficacy of midodrine taken at usual recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus Influenza A.

Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3 5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic of viral replication; analysis of the frequency of emergence of mutants and associated resistance.

Methods:

This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years infected by influenza A virus. Nasopharyngeal washing will be performed at day 0 (randomization), 2, 3, 5 to show the viral replication evolution.

161 patients will be randomized as follows :

* Arm 1 : Midodrine, 2.5 mg, 3 times a day * Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon area.

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Key information

Conditions

Influenza A Virus Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cabinet Médical du Dr ALIBERT, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women aged 18 to 65 years,
  • with no long-term illness,
  • presenting flu-like symptoms for less than 42 hours (nasal congestion, sore throat, muscle soreness, asthenia, headache, chills/sweating, fever…),
  • infection with influenza A virus confirmed with a quick diagnostic test,
  • outpatient care,
  • must provide signed and informed consent,
  • beneficiary of a health insurance.

Exclusion criteria

  • severe form of flu,
  • pregnant women or positive pregnancy test,
  • breastfeeding women,
  • women of childbearing-potential with no efficient contraceptive,
  • history of chronic respiratory disease : asthma or chronic obstructive pulmonary disease,
  • renal failure,
  • Raynaud's disease,
  • history of epilepsy, confusion, hallucinations or of psychoneurotic state,
  • patients with an increased cardiovascular risk (> 20% according to the Framingham scale) or with a cardiovascular history,
  • patients having a congestive heart failure, swollen legs or a posture hypotension,
  • patients who received a influenza vaccine for seasons 2011-2012 or 2012-2013,
  • known hypersensitivity to any component of the treatment,
  • topical use of nasal decongestant (except physiological serum),
  • use of steroids, immunosuppressive or antipsychotics drugs (including treatments for nausea),
  • use of indirect sympathomimetics drugs (ephedrine, methylphenidate, phenylephrine, pseudoephedrine),
  • use of dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide) or vasoconstrictor ergot alkaloids (dihydroergotamine, ergotamine, methylergométrine, methylsergide),
  • known hypertension treated or not,
  • history of bradycardia,
  • history of urinary retention,
  • severe cardiopathy,
  • acute angle-closure glaucoma,
  • severe obliterative vasculopathy,
  • vasospasm,
  • thyrotoxicosis,
  • pheochromocytoma,
  • history of angina pectoris,
  • use of guanethidine and related, iproniazide (non selective MAOIs), alpha-blockers and digitalis drugs
  • use of neuraminidase inhibitors: oseltamivir, zanamivir; and M2 proton-selective ion channel inhibitors: amantadine and rimantadine

Treatment and study plan

Gutron® treatment

Drug

Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.

Primary outcomes

  1. Comparison of viral replication kinetics between the 2 arms

    Time frame: 7 days

    Comparison of the viral load slopes for 7 days post-study treatment start. Viral load will be measured at day 0, 2, 3, 5, and 7

Secondary outcomes

  1. Percentage of patients with a normalized viral load

    Time frame: 7 days

    A normal viral load is defined as a value below the positive threshold of 3 in RT-qPCR at day 2, 3, 5 and 7

  2. Duration and severity of flu symptoms

    Time frame: 7 days

  3. Frequency, duration and level of replication of the virus in nose samples

    Time frame: 7 days

  4. Viral resistance and decrease of sensitivity of collected strains

    Time frame: 7 days

  5. Tolerance of midodrine : incidence of adverse effects

    Time frame: 7 days

    Side effects will be checked at each visit and reported for the entire study timeframe.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FLUMED

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2012
Registry last updated
Jan 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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