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A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03376321
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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 treatment.

Condition or disease Intervention/treatment Phase
Influenza A Drug: Pimodivir 600 mg Drug: Placebo Other: SOC Treatment Phase 3

Detailed Description:
This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Treatment Arm 1 (pimodivir + Standard-of-Care [SOC] treatment)
Participants will receive pimodivir 600 milligram (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) along with SOC treatment. Participants who meet all treatment extension criteria as defined in the protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment is determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of SOC cannot be changed (example, switching one influenza antiviral for another) during either treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in case of suspected adverse event (AE).
Drug: Pimodivir 600 mg
Participants will receive pimodivir 600 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 who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).

Other: SOC Treatment
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.

Placebo Comparator: Treatment Arm 2 (placebo + SOC treatment)
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 morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. 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 of first study drug intake. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either treatment period/extension phase, with the exception that an influenza antiviral may be discontinued in case of a suspected AE.
Drug: Placebo
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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).

Other: SOC Treatment
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.




Primary Outcome Measures :
  1. Participant's Clinical Status Assessed by Hospital Recovery Scale [ Time Frame: Day 6 ]
    The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    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.

  2. Number of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time points for clinical laboratory testing.

  3. Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Screening, Days 28 and 33 ]
    A 12-lead ECG will be performed. An ECG recorded within 1 calendar day before signing of the informed consent form (ICF)/assent form can be used in lieu of the baseline ECG requirement.

  4. Number of Participants With Vital Signs abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with vital signs (temperature, pulse rate, respiratory rate and blood pressure) abnormalities will be reported.

  5. Number of Participants With Peripheral Capillary Oxygen Saturation (SpO2) Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants with SpO2 abnormalities will be reported.

  6. Time From Study Drug Start to Hospital Discharge [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Total length of hospital stay includes total days of hospital stay that is, the time from start of study drug to hospital discharge.

  7. Time From Intensive Care Unit (ICU) Admission to ICU Discharge [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    In the event that a participant required intensive care, the duration for how long the participant remained in the ICU that is (i.e.) the time from ICU admission to ICU discharge will be measured.

  8. Time From Start to End of Mechanical Ventilation [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time from start to end of mechanical ventilation will be measured.

  9. Participant's Clinical Status Assessed by Hospital Recovery Scale [ Time Frame: Days 2 to 5 and 7 to 14 ]
    The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.

  10. Time to Return to Daily Activities [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to return to daily activities will be assessed by means of the participant's response to the question 'Over the past 24 hours, how much has influenza interfered with your ability to carry out your daily activities'. Participants will respond to the above question via an electronic Patient-reported Outcome (ePRO) device by means of the following response scale: Not at all; A little bit; Somewhat; Quite a bit; Very much.

  11. Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    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 pneumonia [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, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).

  12. Number of Participants with All-cause Mortality [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    The number of participants who died due to any cause while on treatment will be assessed.

  13. Percentage of Participants Receiving Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Percentage of participants receiving antibiotic treatment will be reported.

  14. Duration of Antibiotic Treatment [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Duration of antibiotic treatment taken will be reported.

  15. Number of Participants Receiving Extended Treatment [ Time Frame: Day 6 ]
    Number of participants receiving extended treatment will be reported.

  16. Number of Participants Requiring Re-hospitalization [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Number of participants requiring re-hospitalization will be reported.

  17. Number of Participants not Hospitalized at Day 6 [ Time Frame: Day 6 ]
    Number of participants not hospitalized at Day 6 will be reported.

  18. Time to Clinical Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to achieve the clinical response will be determined. Clinical response is defined as achieving 4 of the 5 following vital signs resolution criteria, including at least the fever and oxygen saturation criteria, maintained for at least 24 hours: having no fever (without the use of antipyretics within 8 hours), oxygen saturation of at least 94 percent (%) without oxygen supplementation for at least 24 hours or return to pre-influenza infection oxygen saturation (in patients with chronic oxygen use), improved respiratory status (return to pre- influenza infection oxygen requirement in participants with chronic oxygen use, or a respiratory rate less than or equal to (<=) 24 breaths per min without supplemental oxygen), heart rate 100 beats per minute or lower, systolic blood pressure of 90 millimeter of mercury (mmHg) or higher without inotropic support given within 2 hours of assessment.

  19. Time to Respiratory Response [ Time Frame: Up to 33 days (up to 28 days if no treatment extension) ]
    Time to improvement of respiratory response will be determined. Respiratory response is defined as achieving oxygen saturation of at least 94 percent (%) without oxygen supplementation for at least 24 hours or return to pre-influenza infection oxygen saturation (in patients with chronic oxygen use) and improved respiratory status (return to pre-influenza infection oxygen requirement in patients with chronic oxygen use or a respiratory rate less than or equal to (<=) 24 breaths per min without supplemental oxygen).

  20. Maximum Plasma Concentration (Cmax) of pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The Cmax is the maximum plasma concentration after a dose of pimodivir.

  21. Trough Plasma Concentration (Ctrough) of Pimodivir [ Time Frame: Day 3: pre-dose; Day 5: pre-dose; and Day 6: 12 hours post dose ]
    The (Ctrough) is the plasma concentration just prior to the beginning or at the end of a dosing interval.

  22. Time to Reach Maximum Plasma Concentration (tmax) of Pimodivir [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The tmax is defined as time to reach maximum analyte plasma concentration.

  23. Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12) [ Time Frame: Day 1: 1.5 to 6 hours post dose; Day 3: pre-dose; Day 5: pre-dose and 1.5 to 6 hours post dose; and Day 6: 12 hours post dose ]
    The AUC(0-12) is the area under the plasma concentration-time curve from time zero to 12 hours.

  24. Time to Influenza Viral Negativity [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Time to influenza viral negativity will be determined by quantitative real time - polymerase chain reaction (qRT-PCR) and viral culture from nasal mid-turbinate (MT) swabs.

  25. Viral Load Over Time [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Viral load over time will be measured by qRT-PCR and viral culture in the MT nasal swabs and endotracheal samples.

  26. Number of Participants with Emergence of Viral Resistance to Pimodivir [ Time Frame: Up to Day 19 (up to Day 14, if no treatment extension) ]
    Emergence of viral resistance to pimodivir will be detected by genotyping and/or phenotyping.

  27. Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a taste questionnaire. For overall taste, questions will be answered on a following response scale: No taste, Weak taste, Moderate taste, and Strong taste.

  28. Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire [ Time Frame: Days 1 and 5 (evening) or 6 (morning) ]
    Acceptability of the pimodivir formulation in adolescents will be measured by a swallowability questionnaire. Swallowability questions will be answered on a response scale of 1 to 7: 1. Very difficult; 2. Moderately difficult; 3. Slightly difficult; 4. Neither difficult or easy; 5. Slightly easy; 6. Moderately easy; and 7. Very easy.



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.


Ages Eligible for Study:   13 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
  • Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU)
  • Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms
  • Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening
  • Having a screening/baseline National Early Warning Score (NEWS) of >=4

Exclusion Criteria:

  • Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one day prior to screening
  • Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
  • Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
  • Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
  • Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, any history of a lung transplant)
  • Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376321


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
United States, Arkansas
Nea Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
UCSF Fresno Not yet recruiting
Fresno, California, United States, 93701
Miller Children's at Long Beach Medical Center Not yet recruiting
Long Beach, California, United States, 90806
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94306-5640
United States, Florida
PAB Clinical Research Withdrawn
Brandon, Florida, United States, 33511
Miami Clinical Research Withdrawn
Miami, Florida, United States, 33155
Destin Pulmonary Critical Care, PLLS. Recruiting
Santa Rosa Beach, Florida, United States, 32459
United States, Georgia
Augusta University Not yet recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University Withdrawn
Chicago, Illinois, United States, 60611
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University Of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201-1595
Johns Hopkins University School of Medicine Withdrawn
Baltimore, Maryland, United States, 21218
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University of Massachusetts Medical School Not yet recruiting
Worcester, Massachusetts, United States, 01655
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Wayne State Univ School of Medicine Not yet recruiting
Detroit, Michigan, United States, 48201
Wayne State University Not yet recruiting
Detroit, Michigan, United States, 97205
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research Recruiting
Kalamazoo, Michigan, United States, 49008
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
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Regents of the University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
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The Curators of the University of Missouri on behalf of University of Missouri Health Care Withdrawn
Columbia, Missouri, United States, 65211
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
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Mercury Street Medical Group, PLLC Recruiting
Butte, Montana, United States, 59701
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Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
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Montefiore Medical Center PRIME Recruiting
Bronx, New York, United States, 10467
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Mineola, New York, United States, 11501
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The Ohio State University Wexner Medical Center - James Cancer Hospital Withdrawn
Columbus, Ohio, United States, 43210
Regional Infection Diseases Infusion Center Inc. Withdrawn
Lima, Ohio, United States, 45801
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Lowcountry Infectious Diseases Recruiting
Charleston, South Carolina, United States, 29414
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Dallas, Texas, United States, 75390
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Tomball, Texas, United States, 77375
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Seattle, Washington, United States, 98101
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Wenatchee, Washington, United States, 98801
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Hospital Interzonal General de Agudos Dr. Jose Penna Recruiting
Bahia Blanca, Argentina, B8001DDU
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C.a.b.a., Argentina, 1431
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Cordoba, Argentina, 5000
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Cordoba, Argentina, X5016KEH
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Córdoba, Argentina, 5000
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Córdoba, Argentina, 5000
Hospital Cordoba Recruiting
Córdoba, Argentina, X5004CDT
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El Palomar, Argentina, 1684
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General Roca, Argentina, 8332
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La Plata Lpl Lpl, Argentina, 1900
Instituto Medico Platense Recruiting
La Plata, Argentina, B1900AVG
Hospital Universitario Austral Recruiting
Pilar, Argentina, B1629ODT
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Rosario, Argentina, 2000
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Vicente Lopez, Argentina, B1602DOH
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Flinders Medical Centre Recruiting
Bedford Park, Australia, 5042
Box Hill Hospital Recruiting
Box Hill, Australia, 3128
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Clayton, Australia, 3168
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Melbourne, Australia, 3004
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Melbourne, Australia, 3050
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Parkville, Australia, 3052
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South Brisbane, Australia, 4101
Townsville Hospital Recruiting
Townsville, Australia, 4814
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Westmead, Australia, 2145
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Wien N/A, Austria, 1090
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Wien, Austria, 1100
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Wien, Austria, 1140
Belgium
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Aalst, Belgium, 9300
Institut Jules Bordet Recruiting
Brussel, Belgium, 1000
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1070
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Santa Casa de Misericordia de Belo Horizonte Not yet recruiting
Belo Horizonte, Brazil, 30150-221
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Belo Horizonte, Brazil, 30150-240
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Brasil, Brazil, 30110-063
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Campinas, Brazil, 13060-904
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Canoas, Brazil, 92425
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Passo Fundo, Brazil, 99010-080
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Porto Alegre, Brazil, 90035-903
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Porto Alegre, Brazil, 90035-903
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Porto Alegre, Brazil, 90050-170
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Porto Alegre, Brazil, 90470-340
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 91350-200
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Ribeirão Preto, Brazil, 14048-900
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Sao Paulo, Brazil, 04013-060
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São José Do Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 01221-020
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São Paulo, Brazil, 01227-200
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São Paulo, Brazil, 04038-905
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1202
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1336
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Sofia, Bulgaria, 1606
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Veliko Tarnovo, Bulgaria, 5000
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London Health Sciences Center Withdrawn
London, Ontario, Canada, N6A 5A5
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Sudbury, Ontario, Canada, P3E5J1
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Toronto, Ontario, Canada, M2K 1E1
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Sherbrooke, Quebec, Canada, J1J 3H5
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University of British Columbia Not yet recruiting
Vancouver, Canada, V6Z 1Y6
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Hospital Dr Sotero del Rio Recruiting
Puente Alto, Chile, 8150000
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Clinica del Maule Withdrawn
Talca, Chile, 00000
Hospital Dr Hernan Henriquez Aravena Withdrawn
Temuco, Chile, 47811-51
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Fakultni nemocnice Brno Recruiting
Brno, Czechia, 625 00
Nemocnice Kyjov, p.o. Recruiting
Kyjov, Czechia, 697 01
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Ostrava - Poruba, Czechia, 708 52
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Praha 8 - Libe?, Czechia, 180 81
Krajska nemocnice T. Bati, a.s. Withdrawn
Zlin, Czechia, 76275
France
Centre Hospitalier d'Agen Not yet recruiting
Agen Cedex 9, France, 47923
CHU Amiens - Hopital Sud Not yet recruiting
Amiens Cedex, France, 80054
Hôpital Louis Mourier Not yet recruiting
Colombes, France, 92700
Centre Hospitalier Intercommunal de Créteil Not yet recruiting
Creteil Cedex, France, 94010
CHU Dijon Not yet recruiting
Dijon, France, 21000
Centre Hospitalier Départemental Not yet recruiting
La Roche S/ Yon Cedex 9, France, 85925
CHU de Grenoble - Hôpital Albert Michallon Not yet recruiting
La Tronche, France, 38043
CHU de Limoges, Hopital Dupuytren Not yet recruiting
Limoges, France, 87042
Hôpital Nord - Marseille Not yet recruiting
Marseille Cedex 20, France, 13915
CHU Nantes - Hotel Dieu Not yet recruiting
Nantes Cedex 01, France, 44093
CHU Nantes - Hotel Dieu Withdrawn
Nantes Cedex, France, 44093
CHU de Nice, Hopital de l'Archet Not yet recruiting
Nice Cedex 3, France, 06202
Hopital Saint-Louis Not yet recruiting
Paris Cedex 10, France, 75475
Hôpital Bichat - Claude Bernard Not yet recruiting
Paris, France, 75018
Hopital Cochin Not yet recruiting
Paris, France, 75679
CHU Poitiers - Hôpital la Milétrie Not yet recruiting
Poitiers, France, 86021
CHU Saint-Etienne - Hôpital Nord Not yet recruiting
Saint-Etienne Cedex 2, France, 42055
CHU Tours - Hopital Bretonneau - Maladies Infectieuses Withdrawn
Tours, France, 37044
Germany
Forschungszentrum Borstel Withdrawn
Borstel, Germany, 23845
Klinikum Donaustauf Not yet recruiting
Donaustauf, Germany, 93093
Universitaetsklinikum Carl Gustav Carus TU Dresden Withdrawn
Dresden, Germany, 01307
Universitaetsklinik Erlangen Not yet recruiting
Erlangen, Germany, 91054
Universitaetsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen Not yet recruiting
Hessen, Germany, 35392
Universitaetsklinikum Koeln Not yet recruiting
Koeln, Germany, 50937
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Not yet recruiting
Luebeck, Germany, 23538
Universitätsklinikum Marburg Withdrawn
Marburg, Germany, 35043
LMU Campus Innenstadt Withdrawn
Muenchen, Germany, 80337
Universitaetsmedizin Rostock Withdrawn
Rostock, Germany, 18057
Klinikum Weiden Not yet recruiting
Weiden, Germany, 92637
Universitaetsklinikum Wuerzburg Not yet recruiting
Wurzburg, Germany, 97078
Hungary
Veszprem Megyei Tudogyogyintezete Not yet recruiting
Farkasgyepü, Hungary, 8582
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Withdrawn
Nyíregyháza, Hungary, 04400
Tudogyogyintezet Torokbalint Not yet recruiting
Torokbalint, Hungary, 2045
Csolnoky Ferenc Korhaz Withdrawn
Veszprem, Hungary, 8200
India
Zydus Hospital-Ahmedabad Not yet recruiting
Ahmedabad, India, 380054
Rajiv Gandhi Institute of Medical Sciences Not yet recruiting
Balaga, India, 532001
M S Ramaiah Memorial Hospital Not yet recruiting
Bangalore, India, 560054
KLE University Jawaharlal Nehru Medical College Not yet recruiting
Belgaum, India, 590010
Apollo Hospitals International Limited Not yet recruiting
Gandhinagar, India, 382424
Aware Global Hospital Not yet recruiting
Hyderabad, India, 500035
S. R. Kalla Memorial General Hospital Recruiting
Jaipur, India, 302001
Eternal Heart Care Centre Not yet recruiting
Jaipur, India, 302020
Calcutta Medical Research Institute Not yet recruiting
Kolkata, India, 700027
King George's Medical University Not yet recruiting
Lucknow, India, 226003
Ajanta Research Cemtre Not yet recruiting
Lucknow, India, 226005
Midland Healthcare & Research Center Not yet recruiting
Lucknow, India, 226006
Vinaya Hospital and Research Center Not yet recruiting
Mangalore, India, 575003
Kasturba Medical College Hospital Not yet recruiting
Manipal, India, 576104
Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst Not yet recruiting
Mumbai, India, 400053
Suretech Hospital and Research Centre Limited Not yet recruiting
Nagpur, India, 400012
Chopda Medicare & Research Centre Not yet recruiting
Nashik, India, 422005
Siddhi Hospital Not yet recruiting
Nashik, India, 422007
Suyog Multispeciality Hospital Not yet recruiting
Nashik, India, 422009
BLK Super Specialty Hospital Not yet recruiting
New Delhi, India, 110005
Sir Ganga Ram Hospital Not yet recruiting
New Delhi, India, 110060
Fortis Flight Lieutenant Rajan Dhall Hospital Not yet recruiting
New Delhi, India, 110070
Lifepoint Multispecialty Hospital Not yet recruiting
Pune, India, 411023
Sahyadri Speciality Hospital Not yet recruiting
Pune, India, 411038
Shree Giriraj Multispeciality Hospital Not yet recruiting
Rajkot, India, 360005
BAPS Pramukhswami Hospital Not yet recruiting
Surat, India, 395009
Rhythm Heart Institute Withdrawn
Vadodara, India, 391740
Israel
Haemek Medical Center Not yet recruiting
Afula, Israel, 18101
Barzilai Medical Center Not yet recruiting
Ashkelon, Israel, 78278
Soroka University Medical Center Not yet recruiting
Beersheba, Israel, 84101
Bnei Zion Medical Center Not yet recruiting
Haifa, Israel, 31048
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 3109601
Wolfson Medical Center Not yet recruiting
Holon, Israel, 58100
Hadassah University Hospita - Ein Kerem Not yet recruiting
Jerusalem, Israel, 91120
Sapir Medical Center, Meir Hospital Not yet recruiting
Kfar-Saba, Israel, 4428164
Galilee Medical Center Not yet recruiting
Nahariya, Israel, 2210001
Rabin Medical Center, Beilinson Campus Not yet recruiting
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Kaplan Medical Center Not yet recruiting
Rechovot, Israel, 7610001
Ziv Medical Center Not yet recruiting
Safed, Israel, 13100
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Italy
Azienda Ospedaliero-Universitaria di Ferrara 'Arcispedale Sant'Anna' Withdrawn
Cona, Ferrara, Italy, 44124
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena Recruiting
Milano, Italy, 20122
Ospedale San Giuseppe - Fatebenefratelli Recruiting
Milano, Italy, 20123
Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro Not yet recruiting
Milano, Italy, 20127
ASST Grande Ospedale Metropolitano Niguarda Not yet recruiting
Milano, Italy, 20162
AOU Policlinico di Modena Recruiting
Modena, Italy, 41124
Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo Not yet recruiting
Monza, Italy, 20052
Azienda Ospedaliera Universitaria Maggiore della Carità Not yet recruiting
Novara, Italy, 28100
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia Not yet recruiting
Perugia, Italy, 6132
Ospedale degli Infermi Withdrawn
Rimini, Italy, 47923
Lazzaro Spallanzani IRCCS Not yet recruiting
Roma, Italy, 149
Korea, Republic of
Korea University Ansan Hospital Not yet recruiting
Ansan-Si, Korea, Republic of, 425-707
Chungbuk National University Hospital Not yet recruiting
Cheongju-Si, Korea, Republic of, 28644
Yonsei University Wonju Severance Christian Hospital Not yet recruiting
Gangwon-Do, Korea, Republic of, 220-701
Hallym University Dongtan Sacred Heart Hospital Not yet recruiting
Hwaseong-Si, Korea, Republic of, 18450
Gachon University Gil Medical Center Not yet recruiting
Incheon, Korea, Republic of, 21565
The Catholic University of Korea, Incheon St. Mary's Hospital Not yet recruiting
Incheon, Korea, Republic of, 403-720
Dong-A University Hospital Not yet recruiting
Pusan, Korea, Republic of, 602-715
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 02841
Konkuk University Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
The Catholic University of Korea Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 06591
Hallym University Kangnam Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of, 07441
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of, 152-703
The Catholic University of Korea St. Vincent's Hospital Not yet recruiting
Suwon-Si, Korea, Republic of, 16247
Latvia
Daugavpils Regional Hospital Withdrawn
Daugavpils, Latvia, LV5417
Regional Hospital of Liepaja Not yet recruiting
Liepaja, Latvia, LV-3414
Hospital of Rezekne Not yet recruiting
Rezekne, Latvia, LV-4600
Centre of Tuberculosis and Lung Diseases Not yet recruiting
Riga District, Latvia, LV-2118
Children`s Clinical University Hospital Recruiting
Riga, Latvia, LV-1004
Riga East Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1038
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV1002
Vidzemes Hospital Not yet recruiting
Valmiera, Latvia, LV-4201
Lithuania
Kaunas Clinical Hospital, Public Institution Withdrawn
Kaunas, Lithuania, LT-47144
Klaipeda University Hospital Recruiting
Klaipeda, Lithuania, 92288
Siauliai Republican Hospital, Public Institution Not yet recruiting
Siauliai, Lithuania, 76231
Infectious Diseases Center of Vilnius University Hospital Santaros klinikos Not yet recruiting
Vilnius, Lithuania, 08117
Children Hospital at Vilnius University Hospital 'Santariskiu klinikos' Withdrawn
Vilnius, Lithuania, LT-08406
Malaysia
Hospital Sultanah Bahiyah Recruiting
Alor Setar, Malaysia, 5460
Hospital Selayang Withdrawn
Batu Caves, Malaysia, 68100
Hospital Queen Elizabeth Recruiting
Kota Kinabalu, Malaysia, 88586
Hospital Sultanah Nur Zahirah Recruiting
Kuala, Malaysia, 20400
Hospital Umum Sarawak Recruiting
Kuching, Malaysia, 93586
Hospital Miri Recruiting
Miri, Malaysia, 98000
Hospital Tuanku Jaafar Recruiting
Seremban, Malaysia, 70300
Hospital Sibu Not yet recruiting
Sibu, Malaysia, 96000
Hospital Sungai Buloh Recruiting
Sungai Buloh, Malaysia, 47000
Hospital Taiping Recruiting
Taiping, Malaysia, 34000
Mexico
Hospital Infantil de Mexico Federico Gomez Not yet recruiting
Ciudad De Mexico, Mexico, 6720
JM Research, SC Not yet recruiting
Cuernavaca, Mexico, 62290
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. Withdrawn
Culiacan, Mexico, 80230
Hospital Civil de Guadalajara Fray Antonio Alcalde Not yet recruiting
Guadalajara, Mexico, 44280
Hospital Civil de Guadalajara Dr. Juan I. Menchaca Not yet recruiting
Guadalajara, Mexico, 44340
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez' Not yet recruiting
Mexico, Mexico, 64460
Clinical Trials Mexico S.A. de C.V. Not yet recruiting
Pahucha, Mexico, 42070
Netherlands
Albert Schweitzer Ziekenhuis Not yet recruiting
Dordrecht, Netherlands, 3318 AT
UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
Albert Schweitzer Ziekenhuis Zwijndrecht Withdrawn
Zwijndrecht, Netherlands, 3341LZ
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Tauranga Hospital Recruiting
Tauranga, New Zealand, 3143
Wellington Hospital Recruiting
Wellington, New Zealand, 6021
Peru
Hospital Nacional Daniel Alcides Carrion Not yet recruiting
Callao, Peru, 02
Hospital Nacional Hipolito Unanue Not yet recruiting
El Agustino, Peru, 10
Hospital Dos de Mayo Withdrawn
Lima, Peru, Lima 01
Hospital Maria Auxiliadora Withdrawn
Lima, Peru, LIMA 29
Hospital Central de la Fuerza Aérea del Perú Not yet recruiting
Miraflores, Peru, LIMA 18
Clinica Peruano Americana S.A Not yet recruiting
Trujillo, Peru, 13007
Hospital Nacional Adolfo Guevara Velasco Withdrawn
Wanchaq, Peru
Poland
Wojewódzki Szpital Specjalistyczny im. św. Rafała w Czerwonej Górze Not yet recruiting
Chęciny, Poland, 26-060
Szpital Miejski ZOZ Recruiting
Debica, Poland, 39-200
Centrum Medyczne w Lancucie Sp.z o.o. Recruiting
Lancut, Poland, 37-100
Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego Not yet recruiting
Lodz, Poland, 91-347
Szpital Specjalistyczny im. E.Szczeklika w Tarnowie Withdrawn
Tarnow, Poland, 33-100
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego Not yet recruiting
Wroclaw, Poland, 51-149
NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska Not yet recruiting
Wroclaw, Poland, 51-162
Romania
Spitalul de Boli Infectioase si Tropicale 'Dr. Victor Babes' Not yet recruiting
Bucuresti, Romania, 030303
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' Not yet recruiting
Bucuresti, Romania, 10825
Institutul de Boli infectioase 'Prof Dr Matei Bals' Not yet recruiting
Bucuresti, Romania, 21105
Institutul de Boli infectioase 'Prof Dr Matei Bals' Withdrawn
Bucuresti, Romania, 21105
Spitalul Clinic de Boli Infectioase Cluj Napoca Not yet recruiting
Cluj-Napoca, Romania, 400348
Spitalul Clinic de Boli Infectioase Constanta Not yet recruiting
Constanta, Romania, 900709
Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova Not yet recruiting
Craiova, Romania, 200515
Spitalul Clinic de Boli Infectioase 'Sf. Cuvioasa Parascheva' Galati Not yet recruiting
Judet Galati, Romania, 800179
Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie Not yet recruiting
Judet Suceava, Romania, 720201
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie 'Dr. Victor Babes' Not yet recruiting
Judet Timis, Romania, 300312
Russian Federation
City Hospital #8 Not yet recruiting
Chelyabinsk, Russian Federation, 454000
SBEI HPE Moscow State Medical and Dentistry University n.a. A. I. Evdokimov of the MoH of the RF Withdrawn
Moscow, Russian Federation, 127473
City Hospital # 38 named after Semashko Withdrawn
Saint-Petersburg, Russian Federation, 196601
Institute of Antimicrobial Chemotherapy Withdrawn
Smolensk, Russian Federation, 214019
Clinical Infectious Diseases Hospital n. a. S.P. Botkin Not yet recruiting
St. Petersburg, Russian Federation, 193167
Saint-Petersburg SBIH Children City Hospital 22 Withdrawn
St.Petersburg, Russian Federation, 196657
LLC Reafarm Not yet recruiting
Stavropol, Russian Federation, 355000
Siberian State Medical University Withdrawn
Tomsk, Russian Federation, 634061
Clinical Hospital #3 Not yet recruiting
Yaroslavl, Russian Federation, 150007
Singapore
National University Hospital Recruiting
Singapore, Singapore, 117599
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Slovakia
DFNsP Bratislava Not yet recruiting
Bratislava, Slovakia, 83340
Nemocnica Malacky, Nemocnicna A.S. Recruiting
Malacky, Slovakia, 90122
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. Not yet recruiting
Michalovce, Slovakia, 07101
Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica Not yet recruiting
Ruzomberok, Slovakia, 03426
Nemocnica arm. generala L. Svobodu Svidnik, a.s., Not yet recruiting
Svidnik, Slovakia, 08901
Slovenia
Clinic for infectious diseases Withdrawn
Ljubljana, Slovenia, 1000
South Africa
Clinical Research Centre University of Cape Town Not yet recruiting
Cape Town, South Africa, 7925
Johese Unitas Recruiting
Centurion, South Africa, 157
Abdullah, IA Recruiting
Durban, South Africa, 4001
Sebastian, Peter Recruiting
Durban, South Africa, 4001
DJW Research Recruiting
Krugersdorp, South Africa, 1739
Emmed Research Recruiting
Pretoria, South Africa, 0084
Into Research Recruiting
Pretoria, South Africa, 0181
Limpopo Clinical Research Initiative Recruiting
Thabazimbi, South Africa, 380
Spain
Hosp. Univ. Vall D Hebron Not yet recruiting
Barcelona, Spain, 08035
Hosp. Clinic I Provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Hosp. Univ. Donostia Not yet recruiting
Donostia-San Sebastian, Spain, 20014
Hosp. Gral. Univ. de Elche Not yet recruiting
Elche, Spain, 3203
Hosp. Univ. de Getafe Not yet recruiting
Getafe, Spain, 28905
Hosp. Univ. Dr. Josep Trueta Not yet recruiting
Girona, Spain, 17007
Hosp. Univ. San Cecilio Not yet recruiting
Granada, Spain, 18012
Hosp. Univ. Virgen de Las Nieves Not yet recruiting
Granada, Spain, 18014
Hosp. Univ. de Bellvitge Not yet recruiting
L'Hospitalet De Llobregat, Spain, 08907
Hosp. Univ. de La Princesa Not yet recruiting
Madrid, Spain, 28006
Hosp. Univ. Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Hosp. Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Univ. La Paz Recruiting
Madrid, Spain, 28046
Hosp. Univ. Hm Monteprincipe Not yet recruiting
Madrid, Spain, 28660
Hosp. Univ. Son Espases Withdrawn
Palma De Mallorca, Spain, 07120
Hosp. Clinico Univ. de Santiago Recruiting
Santiago De Compostela, Spain, 15706
Hosp. Alvaro Cunqueiro Recruiting
Vigo, Spain, 36312
Sweden
Department for Heart Failure and Valvular Disease Recruiting
Malmö, Sweden, 205 02
Karolinska Universitetssjukhuset, Huddinge Not yet recruiting
Stockholm, Sweden, 141 86
Norrlands Universitetssjukhus Not yet recruiting
Umeå, Sweden, 901 87
Akademiska Sjukhuset Not yet recruiting
Uppsala, Sweden, 75185
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 80756
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10002
Tri-Service General Hospital Not yet recruiting
Taipei, Taiwan, 114
Taipei Medical University-Wan Fang Hospital Not yet recruiting
Taipei, Taiwan, 116
Chang Gung Memorial Hospital- Linkou Not yet recruiting
Taoyuan County, Taiwan, 333
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Bamrasnaradura Infectious Disease Institute Not yet recruiting
Muang, Thailand, 11000
Srinagarind Hospital Not yet recruiting
Muang, Thailand, 40002
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine Not yet recruiting
Muang, Thailand, 50200
Bumrungrad Hospital Recruiting
Wattana, Thailand, 10110
Turkey
Hacettepe University Medical Faculty Not yet recruiting
Ankara, Turkey, 06100
Adnan Menderes University Not yet recruiting
Aydin, Turkey, 09100
Dicle University Medical Faculty Not yet recruiting
Diyarbakir, Turkey, 21280
Istanbul University Cerrahpasa Medical Faculty Not yet recruiting
Istanbul, Turkey, 34098
Ankara Ataturk Training and Research Hospital Withdrawn
Istanbul, Turkey, 34384
Kocaeli University Medical Faculty Not yet recruiting
Kocaeli, Turkey, 41380
Hacettepe University Medical Faculty Not yet recruiting
Samanpazari, Altindag, Turkey, 06100
Karadeniz Teknik University Medical Faculty Not yet recruiting
Trabzon, Turkey, 61100
Ukraine
Public Institution 'Dnipropetrovsk City Children's Clinical Hospital №6' Withdrawn
Dnipropetrovsk, Ukraine, 49017
Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp. Not yet recruiting
Kharkiv, Ukraine, 61096
Kyiv City Clinical Hospital #9, Department of infectious diseases Withdrawn
Kyiv, Ukraine, 04112
Kyiv Oleksandrivska Clinical Hospital Not yet recruiting
Kyiv, Ukraine, 1601
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy Not yet recruiting
Poltava, Ukraine, 36000
SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course Withdrawn
Sumy, Ukraine, 40022
Sumy State University Not yet recruiting
Sumy, Ukraine, 40030
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM Not yet recruiting
Vinnytsia, Ukraine, 21021
CI Zaporizhzhia City Multibranch Children Hospital #5 Withdrawn
Zaporizhzhia, Ukraine, 69076
Communal Institution City Clinical Hospital #6 Of Zaporizhzhya City Not yet recruiting
Zaporizhzhya, Ukraine, 69035
United Kingdom
Aberdeen Royal Infirmary Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZB
Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Leeds General Infirmary Not yet recruiting
Leeds, United Kingdom, LS1 3EX
North Manchester General Hospital Not yet recruiting
Manchester, United Kingdom, M8 5RB
Musgrove Park Hospital Not yet recruiting
Taunton, United Kingdom, TA1 5DA
Arrowe Park Hospital Withdrawn
Wirral, United Kingdom, CH49 5PE
Vietnam
Bach Mai Hospital Not yet recruiting
Hanoi, Vietnam, 100000
National Hospital for Tropical Diseases Not yet recruiting
Hanoi, Vietnam, 100000
Thanh Nhan Hospital Not yet recruiting
Hanoi, Vietnam
Children's Hospital 1 Not yet recruiting
Ho Chi Minh, Vietnam
Children's Hospital 2 Not yet recruiting
Ho Chi Minh, Vietnam
Nguyen Tri Phuong Hospital Not yet recruiting
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03376321     History of Changes
Other Study ID Numbers: CR108399
2017-002156-84 ( EudraCT Number )
63623872FLZ3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents