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History of Changes for Study: NCT
Study edits or deletions are displayed in red. Study additions are displayed in green. Scroll up to access the controls. Oversight U. Study Description Brief Summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care SOC treatment compared to placebo in combination with SOC dscorts.
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The study will brisbane pakistani escort conducted in 3 phases: screening phase, double-blind treatment period 5 daysa post treatment follow-up period 23 days. The duration of participation in the study for each participant is 28 days. Conditions Conditions: Influenza A Keywords:. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning up to noon.
An influenza antiviral as part of the SOC cannot be changed for example, switching one seeking lonely mexico woman antiviral for another during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event AE.
Participants will receive pimodivir mg, orally, twice daily, for 5 days on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6. Participants may receive SOC treatment as a part of background therapy. Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6 along with SOC treatment.
An influenza antiviral as part of the SOC cannot be changed for example, switching one influenza antiviral for another during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
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Participants will receive placebo matching to pimodivir, orally twice daily for 5 days on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will man seeking woman kyle until the morning of Day 6. Outcome Measures Primary Outcome Measures: 1.
The resolution of influenza-related symptoms is defined as the beginning of the hour period that 7 influenza symptoms cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue are ruxsian most mild or at least back to level of symptom severity in case the participant reported the symptom as pre-existing. of Participants With Adverse Events as a Measure of Safety and Tolerability An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time points for clinical laboratory testing. of Participants With Vital abnormalities as a Measure of Safety and Tolerability of participants with vital temperature, pulse rate, respiratory rate and blood pressure abnormalities will be reported. Percentage of Participants Hospitalized Percentage of participants hospitalized 28 days after ecorts initiation will be reported.
Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment Percentage of participants with complications associated with influenza after the start of study will be reported. Complications include pulmonary complications such as respiratory failure, primary viral pneumonia, secondary bacterial escorts marshall leeds [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma and extrapulmonary complications such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of ly controlled diabetes mellitus, other infections [for example, sinusitis and otitis].
Time to Return to Daily Activities Time to return to daily activities will be assessed by means of the participant's response to the question 'Over the past esforts hours, how much has influenza interfered with your ability to carry out your daily activities'. Participants will respond to the above question through an electronic Patient-reported Outcome ePRO device by means of housto following response scale: Not at all; A little bit; Somewhat; Quite a bit; Very much.
of Participants with All-cause Mortality The of participants who died due to any cause will be assessed. Maximum Plasma Concentration Cmax of pimodivir Rusian Cmax is the maximum plasma concentration after a dose of pimodivir. Trough Plasma Concentration Ctrough of Pimodivir The Ctrough is the plasma concentration just prior to the beginning or at the end of a dosing interval.
Time to Reach Maximum Plasma Concentration tmax of Pimodivir The tmax is defined as time to reach maximum analyte plasma concentration. rusian
Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire Acceptability of the pimodivir formulation in adolescents will be measured by a taste questionnaire. For overall taste, questions will be answered on esorts following response scale: No taste, Weak taste, Moderate taste, and Strong taste.
Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire Acceptability of the pimodivir formulation in adolescents will be measured by a swallowability esscorts. Swallowability questions will be answered on a response scale of 1 to 7: 1. Very difficult; 2. Moderately difficult; 3.
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Slightly difficult; 4. Neither difficult or easy; 5. Slightly easy; 6. Moderately easy; and 7.
Very easy. Time to Influenza Viral Negativity Time to influenza viral negativity will be determined by quantitative real time - polymerase chain reaction qRT-PCR and viral culture from nasal midturbinate MT swabs.
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Time to Resolution of Each of the 10 Individual Influenza-Related Symptoms as Assessed by the PRO Measure Flu-iiQ The resolution of each influenza-related symptom is defined as the beginning of the hour period when the influenza symptom score is at most mild or at least back to level of symptom severity in case the participant reported the symptom as pre-existing. Eligibility Minimum Age: 13 Years Maximum Age: 85 Years Sex: All Gender Based: Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if longueuil escort symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device.
Symptoms must include the following by category: a Respiratory symptoms: cough, sore throat, nasal congestion b Tussian symptoms: headache, body aches or pain, feverishness, fatigue Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test RIDT or, if available, a polymerase chain reaction PCR -based or other rapid molecular diagnostic assay Not be in need of hospitalized medical care at screening.
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Simon, M. Lewis research Inc.
Lewis Research Inc. Antonio A.
Igor Karen, s. Bati, a. Juan I. Kukuru Michalovce, a.
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Svobodu Svidnik, a. Clinico Univ. Scroll up to access the controls Scroll to the Study top. December 18, None earliest Houstn on record 2.
February 28, March 27, April 24, May 3, May 22, June 19, July 17, Cupid escort des plaines 27, January 29, March 21, March escogts, April 3, May 6, May 14, July 26, August 6, September 3, October 1, October 29, November 26, December 24, January 21, February 18, March 17, May 11, June 9, July 7, September 1, November 10, Study Status Record Verification:.