Acute Respiratory Viral Infections due to influenza A or B virus, RSV, adenovirus, or parainfluenza virus 1 or 3 MedDRA version: 17.1 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Isoprinosine
Product Name: Isoprinosine
Pharmaceutical Form: Tablet
INN or Proposed INN: Inosine Acedoben Dimepranol (IAD)
CAS Number: 36703-88-5
Current Sponsor code: Isoprinosine
Concent
Sponsors
Ewopharma AG.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or nonpregnant female subjects aged 18 to 75 years. Female subjects must be either surgically sterile, postmenopausal (no menses during the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, injectable or implanted hormonal contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence). 2. Has an influenza-like illness defined as: • oral temperature of =38°C obtained at study site. If oral temperature measured at screening is 37.5°C and the subject has taken an antipyretic within 4 hours prior to screening • at least 1 of the following respiratory symptoms: cough, sore throat, or nasal obstruction that is considered by the subject to be moderate or severe in intensity (a score of more than 1 on a 4-point scale [Table S2]) , and • at least 1 of the following constitutional symptoms: fatigue, headache, myalgia, or feverishness that is considered by the subject to be moderate or severe in intensity (rated greater than “mild” on a 4-point scale ). 3. Has onset of influenza-like illness no more than 36 hours prior to screening, defined as when the subject experienced fever and at least 1 respiratory symptom and at least 1 constitutional symptom. 4. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements, including completion of the subject diary. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 430 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has immunosuppressive disorder or who is receiving immunosuppressive therapy (eg, immunosuppressants, antitumour agents). 2. Is receiving treatment with xanthine oxidase inhibitors (allopurinol) or uricosuric agents, or treatment with thiazide diuretics (eg, hydrochlorothiazide, chlorthalidone, and indapamide) or loop diuretics (eg, furosemide, torsemide, and ethacrynic acid). 3. Has chronic renal dysfunction (creatinine clearance <50 mL/min). 4. Has liver disorder (severe liver function impairment; aspartate aminotransferase and alanine aminotransferase values greater than 3 times the upper limit of normal). 5. Is lactose intolerant. 6. Has cancer in a nonremission stage (subject with nonmetastatic basal cell or squamous cell skin cancer or other early cancer for which surgical resection is considered to be completely curative is eligible for enrolment). 7. Is a resident of a nursing home or other long-term care institution. 8. Is receiving treatment with zidovudine. 9. Is pregnant or lactating/breastfeeding female. 10. Has received any dose of Isoprinosine, oseltamivir, zanamivir, amantadine, or rimantadine during this period of influenza-like illness. 11. Has received prior treatment with any investigational drug or vaccine within 30 days prior to screening. 12. Has known hypersensitivity to inosine acedoben dimepranol or any of the excipients comprising Isoprinosine from the 500 mg Isoprinosine tablets. 13. Has a medical history of hyperuricaemia or gout. 14. Is unable to take oral medications. 15. Has any preexisting illness that, in the opinion of the investigator, would place the subject at an increased risk through participation in this study. 16. Is a subject who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of Isoprinosine compared with placebo in subjects with laboratory confirmed acute respiratory viral infections due to influenza A or B virus, RSV, adenovirus, or parainfluenza virus 1 or 3.;Secondary Objective: • To evaluate the clinical efficacy of Isoprinosine compared with placebo in subjects with clinically diagnosed influenza-like illnesses. • To evaluate the effect of Isoprinosine compared with placebo: - on ability to perform activities of daily living in subjects with laboratory confirmed acute respiratory viral infections due to influenza A or B virus, RSV, adenovirus, or parainfluenza virus 1 or 3. - on the ability to perform activities of daily living in subjects with clinically diagnosed influenza-like illnesses. - on the incidence of complications of influenza-like illness and laboratory confirmed acute respiratory viral infections due to influenza A or B virus, RSV, adenovirus, or parainfluenza virus 1 or 3. • To assess the safety of Isoprinosine compared with placebo in the treatment of influenza-like illnesses.;Primary end point(s): Time to resolution of all influenza-like symptoms present at baseline to none (ie, score of 0 on influenza-like symptoms assessment scale);Timepoint(s) of evaluation of this end point: Subjects will be instructed to record the presence of influenza like illness respiratory and constitutional symptoms once daily in the evening using the 4 point scale on subject diary cards. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to resolution of all constitutional symptoms present at baseline to none (ie, score of 0 on influenza-like symptoms assessment scale) • Time to resolution of cough present at baseline to none (ie, score of 0 on influenza-like symptoms assessment scale) • Time to resolution of sore throat present at baseline to none (ie, score of 0 on influenza-like symptoms assessment scale) • Time to resolution of nasal obstruction present at baseline to none (ie, score of 0 on influenza-like symptoms assessment scale) • Time to absence of fever (oral temperature of =37.5°C for at least 2 consecutive readings at least 12 hours apart) • Time to resumption of normal activity (ie, score of 0 on daily activities assessment scale) • Frequency of viral respiratory infection complications of hospitalisation, death due to influenza-like illness or complications of influenza-like illness, and requirement for antibiotics to treat secondary bacterial infections ;Timepoint(s) of evaluation of this end point: Subjects will be instructed to measure oral temperature using a digital thermometer 3 times daily and record these readings in the subject diary cards starting from Day 1 after the first dose of study drug until the EOT Visit. | — |
Countries
Czech Republic, Slovakia
Contacts
Public ContactMedical Director
Ewopharma International, s.r.o.
Outcome results
None listed