Clinical trial NCT06207058: Evaluation of a Screen and Treat Protocol for Influenza
Official title: Evaluation of a Screen and Treat Protocol for Influenza in Socially Vulnerable Communities.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Influenza
Lead sponsor: Tricore, Inc
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in respiratory hot spots and socially vulnerable communities identified in the algorithm.

Brief summary: This study seeks to demonstrate that the laboratory can mitigate respiratory virus transmission in underserved populations by using laboratory data to identify communities at risk for increase vial activity (hot spots) and intervening with a test-to-treat model provides increased access to influenza diagnostics and treatment in vulnerable and underserved communities.

Detailed description: The investigators have developed an analytic algorithm that uses measures from the CDC COVID-19 Hot Spot Criteria and Brown University School of Public Health to determine COVID-19 and Influenza Hot Spots and Testing Deserts, respectively. The Hot Spot designation was based on the CDC county-specific Hot Spot criteria that has been used to deploy resources for interventions (i.e., laboratory testing, community mitigation, health communications and health care) specific needs for the communities of interest. The CDC hot spot criteria is based on COVID-19 rates at the county level. The adaptations to the criteria allows interventions to focus on a concentrated community and deliver the interventions in places that the community is already engaging, such as community centers, senior centers and parks.

Through collaboration with local community centers, the investigators are able to deploy a mobile testing unit to a community center, park or senior center that is in close proximity to the identified neighborhood for rapid onsite testing for Influenza A\&B and SARS-CoV2 using the cobas Liat system.

New Mexico has adopted "New Mexico Board of Pharmacy Protocol for Pharmacists Prescribing of Dangerous Drugs in Conjunction with Point of Care Testing" (NMBOP POCT Protocol, Appendix 5) that allows pharmacists the prescriptive authority to prescribe Influenza antiviral therapy in conjunction with a positive point of care test (POCT). TriCore employs two (2) on-site clinical pharmacists who will follow all of the pharmacist mandates included in the regulation to prescribe and distribute Xofluza according to the approved protocol in the test-to-treat model presented in this study. The NMBOP PCOT Protocol documents the eligibility and requirements of the certified prescribing pharmacists (pharmacist) following this protocol.

The pharmacist will perform a screening physical assessment, health assessment and medical history for the patient. If the subject meets the inclusion criteria, they will have a point of care test performed. If the subject meets the exclusion criteria, they will be excluded from the study. Testing will be performed using the cobas® SARS-CoV-2 \& Influenza A/B assay on the cobas® Liat® system from a self-collected nasal swab. Subjects who test positive for influenza A or B will be prescribed Xofluza with no additional refills. The pharmacist will follow-up with the patient 24-48 hours following administration for evaluation of signs/symptoms and will refer the patient to their primary care provider, provider, or clinic for recommended laboratory testing and follow-up if appropriate.

All subjects eligible for Xofluza will receive patient education and counseling on drug information, adherence, side effects, and other patient educational materials, as appropriate. All subjects eligible for influenza antiviral therapy, but having contraindications to the therapy, or do not wish to use the therapy will be referred to their primary care provider, provider, or clinic for further evaluation.

Subjects testing positive for SARS-CoV-2 will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. Subjects testing negative for all targets (SARS-CoV-2 and Influenza A\&B) with a high index of suspicion for influenza, will be referred by the pharmacist to the subjects' primary care provider, provider, or clinic for further medical assessment and follow-up, if appropriate. All subjects will receive a follow-up call 14-days following the study visit to assess their symptom resolution and the impact of their illness on their well-being

The mobile testing unit will be deployed a minimum of 2 times per week following the determination of the influenza season by the New Mexico Department of Health. The investigators expect to screen 50-100 patients per week for the duration of the influenza season (approximately 12 weeks) for a total of 600-1,2000 patients. With an anticipated 10% positivity rate for influenza, the investigators expect at least 5-10 patients per week to be eligible for treatment for a total of 60-120 subjects eligible over the course of the study. All subjects will be provided a survey to evaluated their ability to access respiratory virus testing and their acceptance of and trust in using a mobile unit for access to treatment and therapeutics. Patients positive for SARS-CoV-2 will be counseled on options for treatment and follow up for COVID-19 infection. All subjects enrolled in the study will receive a follow-up phone call 14-days following the initial screening visit.

Eligibility criteria: Inclusion Criteria:

* Adult patients: Signed informed consent by any patient capable of giving consent, or, where the patient is not capable of giving consent, by his or her legal/authorized representative.
* Adolescent patients not able to legally consent: written informed consent for study participation is obtained from patient's parents or legal guardian, with assent as appropriate by the patient, depending on the patient's level of understanding and capability to provide assent
* Age ³ 5 years at the time of signing the Informed Consent Form/Assent Form
* Ability to comply with the study protocol, in the investigator's judgment.
* Presence of (a) fever (≥38.0 °C per tympanic or rectal thermometer; ≥37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
* The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse):
* Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method.
* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (³ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
* Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

* Patients who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
* Patients who have received Xofluza for the current influenza infection
* Known contraindication to neuraminidase inhibitors
* Patients weighing \< 20 kg
* Patients unable to swallow tablets
* Patients with known severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
* Patients with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
* ALT or AST level \> 5 times the upper limit of normal (ULN) or ALT or AST \> 3 times the ULN and total bilirubin level \> 2 times the ULN
* Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
* Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* Known hypersensitivity to Xofluza (baloxavir marboxil) or the drug product excipients

Primary outcomes:
measure: Symptom Status
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: TriCore Mobile Unit
state: New Mexico
Study officials:
affiliation: Medical Director, Tricore Research Institute
name: Michael Crossey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: