BridgeMD
New treatment option for Influenza
Official title pH1N1 Blinded Challenge Study
ClinicalTrials.gov ID: NCT07110532
What this study is testing
What is A/Arkansas/08/2020 (pH1N1)?
A/Arkansas/08/2020 (pH1N1) is an investigational medicine, being studied as a potential treatment for influenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures.
- Phase 1: an early, usually small safety study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Provides signed and dated informed consent form prior to the initiation of any trial procedures.
- Able to understand and agrees to comply with all planned trial procedures and to be available for all study visits.
- Age \>/= 18 and \</= 55 years at time of enrollment.
- Must agree to collection of venous blood and nasal absorption specimens per protocol and enrollment in DMID 19-0025 biorepository protocol for use of...
- In good general health.\ \ Good health, as determined by medical history, medication use and physical examination to evaluate ongoing chronic medical...
You likely can't join if
- and treatment poses no additional risk to participant safety or assessment of adverse events. This also includes no change in prescription...
- Able to take oral medication and willing to receive oseltamivir phosphate and/or baloxavir marboxil as part of the study.
- Participants of childbearing potential\ agree to the use of acceptable forms of contraception\ \ for at least 30 days prior to enrollment and agree...
- Non-smoker or non-habitual smoker\ of tobacco, e-cigarettes, or marijuana \ A non-habitual smoker is a person who smokes no more than four...
- No self-reported or known history of alcoholism within the 2 years prior to enrollment.
- No self-reported or known history of illicit drug use for at least 30 days prior to enrollment.
See the full eligibility criteria
Who can join
- Provides signed and dated informed consent form prior to the initiation of any trial procedures.
- Able to understand and agrees to comply with all planned trial procedures and to be available for all study visits.
- Age \>/= 18 and \</= 55 years at time of enrollment.
- Must agree to collection of venous blood and nasal absorption specimens per protocol and enrollment in DMID 19-0025 biorepository protocol for use of residual/repository research blood specimens.
- In good general health.\ \ Good health, as determined by medical history, medication use and physical examination to evaluate ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have...
What rules you out
- and treatment poses no additional risk to participant safety or assessment of adverse events. This also includes no change in prescription medication, dose, or frequency as a result of new symptoms or deterioration of...
- Able to take oral medication and willing to receive oseltamivir phosphate and/or baloxavir marboxil as part of the study.
- Participants of childbearing potential\ agree to the use of acceptable forms of contraception\ \ for at least 30 days prior to enrollment and agree to use such a method during study participation. \ Childbearing...
- Non-smoker or non-habitual smoker\ of tobacco, e-cigarettes, or marijuana \ A non-habitual smoker is a person who smokes no more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juul...
- No self-reported or known history of alcoholism within the 2 years prior to enrollment.
- No self-reported or known history of illicit drug use for at least 30 days prior to enrollment.
- Agrees not to use the listed prescription or over the counter medications\ within 7 days prior to confinement and through the confinement period\ \ . \ Oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine...
- Screening pulse is 55 to 100 beats per minute, inclusive\ \ Screening pulse values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to...
- Screening systolic blood pressure is 90 to 140 mmHg, inclusive\ \ Screening systolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated...
- Screening diastolic blood pressure is 55 to 90 mmHg, inclusive\ \ Screening diastolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or...
- Screening SpO2 \>/= 95 percent
- Screening respiratory rate is \</= 16
- Screening oral temperature is \<100.4 degrees Fahrenheit
- Screening body mass index (BMI) \>/=18.5 and \<40 kg/m\^2 at screening 19 Screening
- Screening lab test results are within acceptable parameters:\
- White blood cell (WBC), Absolute lymphocyte count (ALC), Hemoglobin (Hgb), Platelet (PLT). Lab tests within normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated...
- Alanine transferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase, Alkaline Phosphatase (ALP), Total Bilirubin, and Creatinine (Cr). Low values are acceptable for trial inclusion as they are not...
- Has a negative test result for hepatitis B surface antigen, hepatitis C virus antibody\ , or HIV types 1 or 2 antibodies at screening. \ Persons testing positive for hepatitis C virus antibody with a history of...
- Electrocardiogram (ECG) and chest X-ray (CXR) at screening are within normal range or are not deemed clinically significant\ \ As determined by the site PI or designated clinician licensed to make medical diagnoses and...
- Negative respiratory virus panel (including influenza A and B, and SARS-CoV-2) by certified polymerase chain reaction (PCR)-based assay on Day -2 and Day -1.
- Agrees to remain in the confinement unit for at least 6 days after enrollment and until they meet discharge criteria.
- Agrees to adhere to lifestyle considerations during the study. Note: Deviations of lifestyle considerations will be reported as protocol deviations but not as eligibility deviations. Exclusion Criteria:
- A history (self-reported or medically documented) of medical or psychiatric condition(s)\ or physical exam finding that precludes participation.
- Any condition that, in the opinion of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, might interfere with the safety of the participant and/or study objectives...
- Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications (Inhaled, oral, or intravenous corticosteroids, leukotriene modifiers, long and short acting beta agonists...
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult
- Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, encephalopathy, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis). A history of febrile seizures during childhood alone is not...
- Anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration
- Significant abnormality altering anatomy of nose/nasopharynx (including significant nasal polyps), clinically significant nasal deviation, nasal/sinus surgery within 180 days prior to enrollment, spontaneous epistaxis...
- Significant immunodeficiency
- Known infection by human immunodeficiency virus (HIV) or hepatitis B virus, or known untreated hepatitis C virus infection
- Ongoing malignancy or diagnosis of malignancy in the last five years (excluding squamous cell or basal cell carcinoma of the skin)
- Diabetes
- Blood dyscrasias or significant disorder of coagulation
- HAI antibody titer \>1:40 against influenza A/Arkansas/08/2020 (pH1N1) at screening
- Current or within 4-month use of medications that may be associated with impaired immune responsiveness\ \ Including, but not limited to, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic...
- Current pregnancy\ or lactation \ Participants of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test after admission to the confinement unit but before...
- Presence of an internal cardiac device such as a pacemaker or other implanted electronic medical devices
- Has received blood or blood products in the last six months or has plans to donate blood or blood products in the duration of the study
- History of a previous severe allergic reaction to any drug or biologic with generalized urticaria, angioedema, or anaphylaxis
- Allergy or intolerance to treatments for influenza (including any neuraminidase inhibitors or baloxavir marboxil)
- Allergy to two or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides)
- Allergy to excipients in the challenge virus inoculum
- Presence of any febrile illness or symptoms suggestive of a respiratory infection at the time of enrollment, the time of confinement, or Day 1 pre-challenge
- Close contact with anyone known or suspected to have a respiratory viral illness within 7 days prior to enrollment
- Currently enrolled in any other investigational study or plans to enroll in any other study within the period of this study\ \ Co-enrollment in an observational study, an investigational study in a follow-up/post...
- Received any live vaccine in the 4 weeks prior to enrollment.
- Received any influenza vaccine in the 4 months prior to enrollment or plans to receive influenza vaccine during the study
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.