[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"covid--19\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:covid--19":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,77,105,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100645446","phase-1-a-safety-reactogenicity-and-immunogenicity-trial-of-rvx-scpd9-booster-intranasal-covid-19-vaccine-100645446",false,"NCT07703475","A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine","A Phase 1, Open-Label, Safety, Reactogenicity, and Immunogenicity Trial of RVX-sCPD9, a Live-Attenuated SARS-CoV-2, as a Booster Vaccine, Via the Intranasal Route in Previously Vaccinated Adults","Inclusion Criteria:\n\n1. Provides written informed consent before initiation of any study procedures.\n2. Able to understand and agree to comply with planned study procedures and be available for all study visits.\n3. Non-pregnant adults, 18 through 64 years of age at the time of study product administration.\n4. Participants of childbearing potential\\* must agree to use or have practiced true abstinence\\*\\* or use at least one acceptable primary form of contraception\\*\\*\\*.\n\n   \\*These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation\u002Fsalpingectomy).\n\n   \\*\\*True abstinence is 100% of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods.\n\n   \\*\\*\\*Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, intrauterine devices, birth control pills, and injectable\u002Fimplantable\u002Finsertable\u002Ftransdermal hormonal birth control products. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.\n5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.\n6. In general good health\\*.\n\n   \\*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses\u002Fconditions that have been present for at least 90 days, which would affect the assessment of the safety of participants. Chronic medical diagnoses\u002F conditions should be stable for the last 30 days (i.e., no hospitalizations, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis\u002Fcondition 30 days before the study product administration. Any prescription change due to a change of health care provider, insurance company, etc., or done for financial reasons and in the same class of medication will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.\n7. Receipt of a complete primary authorized or approved COVID-19 vaccine series and at least one booster\\* with the last vaccination at least 16 weeks before study product administration.\n\n   \\*Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized\u002Flicensed vaccine, though doses may have been received during a clinical trial (see MOP for further details).\n8. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per the investigator's discretion\\*.\n\n   \\*Laboratory evaluations include White Blood Cells \\[WBCs\\] with differential, hemoglobin \\[Hgb\\], platelets \\[PLTs\\], Alanine Transaminase \\[ALT\\], Aspartate Transaminase \\[AST\\], Creatinine \\[Cr\\], Alkaline Phosphatase \\[ALP\\], and Total Bilirubin \\[T. Bili\\]). Clinical laboratory evaluations that are below the site reference range, but not graded by the toxicology table, are not exclusionary unless deemed clinically significant by an investigator.\n9. Must agree to have samples stored for secondary research.\n\nExclusion Criteria:\n\n1. Positive SARS-CoV-2 PCR at screening.\n2. Abnormal vital signs (Grade 1 or higher)\\*.\n\n   \\*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \\>\u002F= 141 mmHg or \\\u003C\u002F= 89 mmHg. Diastolic blood pressure (DBP) \\>\u002F= 91 mmHg. Heart rate (HR) is \\>\u002F= 101 beats per minute or \\\u003C\u002F= 54 beats per minute. Oral temperature \\>\u002F= 38.0 degrees Celsius (100.4 degrees Fahrenheit).\n3. Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.\n4. Participant who is pregnant or breastfeeding.\n5. Blood or plasma donation within 4 weeks before study product administration.\n6. Receipt of antibody or blood-derived products within 90 days before study product administration.\n7. Any self-reported or documented significant medical or psychiatric diseases\\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.\n\n   \\*Significant medical or psychiatric conditions include but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, ongoing malignancy, or recent diagnosis of malignancy in the last five years, excluding treated basal and squamous cell carcinoma of the skin and cervical carcinoma in situ, which are allowed.\n8. Neurological conditions\\*.\n\n   \\*Including history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.\n9. History of significant respiratory disease currently requiring daily medications, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years.\n10. History of cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis, pericarditis, or uncontrolled cardiac arrhythmia.\n11. Any autoimmune disease, including hypothyroidism, without a defined non-autoimmune cause.\n12. Has an acute illness determined by the site PI or appropriate sub-investigator within 72 hours before study product administration\\*.\n\n    \\*An acute illness that is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.\n13. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen\u002Fantibody test at screening.\n14. Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections, and chronic\\* immunosuppressant medication within the past 6 months\\*\\*.\n\n    \\*Chronic means more than 14 continuous days.\n\n    \\*\\*Ophthalmic and topical steroids are allowed. See exclusion 19 for intranasal steroids.\n15. Has received any investigational study product within 60 days, or 5 half-lives, whichever is longer, before study product administration or is planning to receive one during the study.\n16. Has a history of hypersensitivity or severe allergic reaction\\* to any previous licensed or unlicensed vaccines or the candidate study product components\\*\\*.\n\n    \\*(e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction).\n    * See IB for study product formulation.\n17. Received or plans to receive licensed inactivated\u002Fsubunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.\n18. Plan to receive a COVID-19 booster vaccine within the 180 days following study product administration.\n19. Regular use of intranasal medications, including steroids, and sinus rinsing treatments\\*.\n\n    \\*Participants must have had no intranasal medication use for 30 days before study product administration and do not plan to use intranasal medications for 30 days after study product administration for medications other than steroids and for 6 months after study product administration for intranasal steroids (including over the counter (OTC) fluticasone). Participants should not use nasal irrigation or sinus rinsing treatments (e.g., Neti pots or saline washes) for 28 days after the study product administration and 7 days before study visits for the duration of the trial.\n20. Use of illicit intranasal drugs in the 5 years before study product administration or plans to use during the study.\n21. Current smoker (including cigarettes, marijuana, and vaping) or smoking within the prior 3 months.\n22. Planned international travel between study product administration and Day 29 visit.\n23. Any significant nasal or upper airway disease\\*.\n\n    \\*Including, but not limited to, being prone to epistaxis, has a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head\u002Fneck radiation history, anosmia\u002Fdysosmia, and certain ear, nose and throat (ENT) conditions, including major anatomic nasopharyngeal abnormality or sinus polyp disease due to chronic sinusitis.\n24. Living with a person who has a condition that predisposes to high risk of severe COVID-19 or \\>\u002F=2 conditions that predisposes to increased risk of COVID-19 per IDSA guidelines.\n25. Healthcare workers with patient-facing responsibilities.\n26. Resides in or works in a nursing home or other skilled nursing facility.\n27. Allergy or contraindications to nirmatrelvir, ritonavir, or remdesivir.",true,"ALL","18 Years","64 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating four dose levels of RVX-sCPD9 administered IN (10\\^2, 10\\^3, 10\\^4, 5 x 10\\^4 FFU). A sample size of 80 participants (20 participants in each cohort).\n\nThe primary objective is to evaluate the safety and reactogenicity of a single IN administration of 4 ascending dosages of RVX-sCPD9 in previously vaccinated healthy adults.",[28],"COVID -19",[30,31,32,33,34,35,36,37,38,39],"Boost","Boster","Coronavirus","COVID","Intranasal","Next Generation","Phase 1","RVX-sCPD9","SARS-CoV-2","Vaccine","NOT_YET_RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":22},"2026-08-15",{"date":48,"type":22},"2027-11-15",{"name":50,"class":51},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",4,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100627233","phase-1-a-study-evaluating-mdx2301-in-healthy-adults-and-adults-at-higher-risk-for-severe-covid-19-100627233","NCT07445971","A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.","A Phase 1a\u002Fb Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19","Inclusion Criteria\n\nHealthy Adults\n\n1. Participant is a healthy male or female, 18 to 64 years of age.\n2. Participant is in good health in the opinion of the investigator.\n\n   Adults at Higher Risk for Developing Severe COVID-19:\n3. Participant is a male or female, 18 to 64 years of age.\n4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:\n\n   1. Asthma\n   2. Diabetes\n   3. Cerebrovascular disease, which affects blood flow to the brain.\n   4. Chronic kidney disease\n   5. Chronic lung disease\n   6. Cardiac disease\n   7. Chronic liver disease\n   8. Cystic fibrosis\n   9. HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening.\n   10. Sickle cell disease or thalassemia\n5. Participant is clinically stable with no clinically significant abnormalities.\n6. Participant has not been hospitalized within the 12 months prior to screening or is not expected to be hospitalized during the study due to underlying medical conditions.\n\n   All Participants\n7. Female participants of childbearing potential must have a negative urine pregnancy test.\n8. Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method.\n9. Participant is able to understand and sign the informed consent form prior to undergoing any study procedures.\n10. Participant is willing and able to comply with scheduled visits and procedures.\n\nExclusion Criteria:\n\nHealthy Adults\n\n1. Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.\n2. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.\n\n   Adults at Higher Risk for Severe COVID-19:\n3. Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.\n4. Participant has evidence of active hepatitis B or hepatitis C infections at screening.\n\n   All Participants\n5. Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1.\n6. Participant tests positive for SARS-CoV-2 infection at screening.\n7. Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1.\n8. Participant has received a SARS-CoV-2 vaccine prior to dosing.\n9. Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1.\n10. Participant has received or is expected to receive for the duration of the study immunoglobulin, blood-derived products, high-dose systemic corticosteroids, or other immunosuppressant drugs within 6 months prior to Day 1.\n11. Participant is pregnant, breastfeeding, or seeking pregnancy while on the study.\n12. Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection.\n13. Participant had major surgery within 30 days prior to Day 1.\n14. Participant has donated blood prior to screening.\n15. Participant has any skin condition and\u002For tattoo that may interfere with the evaluation of safety at the injection site.\n16. Participant has a history of alcoholism or illicit drug use prior to screening or a positive test for drugs of abuse at screening or on Day -1.\n17. Participant is a current smoker or user of other nicotine containing products on a daily basis.\n18. Participant has received an investigational product within 30 days prior to Day 1.\n19. Participant has a known hypersensitivity to any components of MDX2301, any of its excipients or closely related compounds.\n\n    For All Participants, Temporary Exclusions for Randomization on Day 1 if Remains within the Screening Window:\n20. Participant has any acute illness, within 3 days of Day 1.\n21. Participant has vital signs considered by the investigator to be clinically significant prior to study drug administration.\n22. Participant has had close contact with anyone confirmed to have SARS-CoV-2 infection within the 7 days prior to Day 1.\n23. Any acute drug therapy prescribed by a physician within 7 days prior to Day 1.",{"count":21,"type":22},[25],"This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.",[28,64],"COVID-19 (Prevention)","RECRUITING","2026-05-15",{"date":68,"type":44},"2026-05-18",{"date":70,"type":44},"2026-03-24",{"date":72,"type":22},"2027-12",{"name":74,"class":75},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":18,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":52},"100616183","analysis-of-suicidal-behavior-among-children-and-adolescents-in-the-auvergne-rhone-alpes-region-during-the-covid-19-pandemic-period-100616183","NCT07302295","Analysis of Suicidal Behavior Among Children and Adolescents in the Auvergne-Rhone-Alpes Region During the Covid 19 Pandemic Period","Clinical and Socioeconomic Characteristics of Suicidal Behaviour in Children and Adolescents During the Covid19 Pandemic Period in Auvergne-Rhône-Alpes. Prospective Quantitative and Qualitative Study","TSPedCovid","Inclusion Criteria:\n\n* The population (subjects and controls) will be divided into age categories:\n\n  * Pre-adolescents (≥ 8 years and \\\u003C 11 years)\n  * Adolescents (≥ 11 years and \\\u003C 15 years)\n  * Older adolescents (≥ 15 years and \\\u003C 18 years)\n\nSubjects with suicidal behavior during the health crisis (Group 1):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2020 to 2022.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and\u002For 2022 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n\nSubjects with suicidal behavior during the health crisis with qualitative interviews (Group 1b):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2020 to 2022.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and\u002For 2022 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n* Randomly selected from the population of Group 1.\n* For whom the parent(s) and\u002For the subject have signed informed consent.\n\nControls with suicidal behavior before the health crisis (Group 2):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2018 to 2019.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2018 and\u002For 2019 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n\nExclusion Criteria:\n\n\\- Subjects with Suicidal Behavior during the Health Crisis with and without Qualitative Interviews (Group 1 and 1b):\n\n• Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2020 to 2022.\n\nControls with Suicidal Behavior before the Health Crisis (Group 2):\n\n* Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2018 to 2019.\n* Intercurrent illness with a life expectancy of less than 24 hours.\n\nFor Group 1:\n\n* Pregnant, postpartum, or breastfeeding women.\n* Persons deprived of liberty by judicial or administrative decision.\n* Adults subject to a legal protection measure (guardianship, curatorship).\n* Persons not affiliated with a social security scheme or beneficiaries of a similar scheme.\n* Persons who do not understand and do not speak French.","8 Years",{"count":87,"type":22},6500,[89],"NA","In 2020, the world is hit by a global health crisis due to a pandemic following the appearance of Sars-cov-2 or \"covid-19\". This pandemic was accompanied by a constant fear of contamination and death, relayed by the media. In France, the government proposed in response to the arrival of this virus on French territory. This policy was implemented in different ways over 3 distinct periods: strict containment at the start of the epidemic, then a \"lighter\" one, and finally a period of social restrictions without between these periods. This policy had a direct and rapid impact on the population's daily routines. Children and adolescents, are more susceptible to psychological trauma, as stress has a direct and psychic development. Studies have shown deleterious impact of the French health situation on the paediatric population. They point to an increase of psychological disorders such as depression and anxiety in the under -20s population, and an increase in suicidal gestures over the 2020-2021 period, with rates remaining higher than in previous years. Suicide is the 2nd leading cause of death in the population aged 15-24.\n\nStudies continue to focus on the incidence of suicidal gestures of suicidal gestures and psychological disorders, and few of them examine the factors linked to the increase in these incidences, the traumatic impact or the story of the trajectory. Similarly, the few studies focus only on the population aged 12 and over, and in some cases, do not distinguish between age groups (15-24 or under 20).\n\nInvestigators believe that the various periods of social restrictions and eco-anxiety caused by the pandemic may have influenced suicidal behaviour in this population.\n\nThe main objective of this study is to investigate the clinical and socio-economic characteristics of the pediatric population who experienced suicidal behaviors in the Auvergne Rhone Alpes region during the covid 19 pandemic.",[92,28],"Suicidality",[94,95,96],"suicide","pediatrics","covid-19",{"date":68,"type":44},{"date":99,"type":44},"2026-05-06",{"date":101,"type":22},"2028-02",{"name":103,"class":104},"Hospices Civils de Lyon","OTHER",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":76},"100604284","preparedness-through-respiratory-virus-epidemiology-and-community-engagement-100604284","NCT07147517","Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT","Community Testing Component:\n\nInclusion:\n\n\\- All community members are able to participate in the community testing component.\n\nExclusion:\n\n\\- There is no exclusion criteria and participants will not be excluded based on pregnancy status or age.\n\nFor Component A:\n\nInclusion:\n\n* All ages\n* AND Lives in service area of a recruitment center (i.e., within range of courier pick up)\n* AND Plans to remain living in a recruitment area for the next 2 years.\n\nExclusion:\n\n* Inability to communicate in a language in which consent forms, materials, etc. are available\n* OR Incarcerated\n* OR Living in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* OR Unable\u002Funwilling to participate in planned data and specimen collections\n* OR Unable to comply with study procedures, as determined by study investigators\n* OR Participation in clinical trials of investigational agents for respiratory viral infections during the three months prior to enrollment and for the duration of the study.\n\nFor Component B:\n\nInclusion:\n\nIndex case:\n\n* Detection of priority respiratory pathogen via laboratory or point-of-care test on the day of eligibility screening or in the previous 5 days, AND\n* Lives in service area of a recruitment center (i.e., within range of courier pick up), AND\n* Lives in a household with ≥1 other person and plans to remain in the household for at least the duration of specimen collection (i.e., 14 days), AND\n* Has not been hospitalized since the date of symptom onset.\n\nHousehold contacts:\n\n* Routinely sleep in the same household as index case and slept in household ≥1 night in the 7 days before index case symptom onset, AND\n* Plan to remain in the household for at least the duration of specimen collection (i.e., 14 days).\n\nHousehold:\n\n* There is ≥1 non-ill household member (i.e., asymptomatic and has not tested positive for the virus of the index case) on the day of eligibility screening or in the previous 5 days,\n* AND all symptomatic persons in the household had a symptom or diagnosis onset date on the day of eligibility screening or in the previous 5 days.\n\nExclusion:\n\nIndex case:\n\n* Lives in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* Meet any A1 exclusion criteria\n\nHousehold contacts:\n\n* Has been hospitalized any time since date of primary case symptom onset\n* Meets any A1 exclusion criteria\n\nHousehold:\n\n* The enrollment visit occurs \\>6 days after the first symptom onset of primary case\n* The primary case in the household is not enrolled\n* The primary case has been hospitalized any time after the date of symptom onset",{"count":114,"type":22},25000,"5 Years","OBSERVATIONAL","The CHARM network will be established through three primary institutions-Beth Israel Deaconess Medical Center (BIDMC), the University of California San Diego (UCSD), and the University of Washington (UW)-along with their subcontracting institutions. At UCSD and partner sites, the CHARM network will be implemented via the PREVENT project. All PREVENT participants will be consented in to Component A0 (Community Testing) and a subset of A0 participants will be invited to participate and will be consented into the other components: Component A (Ongoing Testing); Component A Sub-study (Immunology); Component B (Household Transmission).\n\nComponent A0 participants (Community testing) will be members of the community who are interested in accessing testing for respiratory infections and will be asked to provide limited information that will then be used for screening for study Components A and\u002For B.\n\nParticipants in Component A (Ongoing Testing ) will undergo weekly symptom screening. If they report symptoms, they will be asked to provide a nasal swab and complete illness questionnaires on the day they report symptoms (Day 0) and again on Days 7 and 14. Participants in Component A Sub-study (Immunology) will provide blood and saliva\u002Fnasal fluid samples twice a year, as well as before and after infection and\u002For immunization against priority pathogens.\n\nParticipants in Component B (Household Transmission) will complete daily symptom questionnaires and nasal swabs for 14 days following enrollment, regardless of symptoms. Those who are symptomatic at enrollment will also complete retrospective daily diaries from symptom onset to the enrollment date. Additionally, they provide blood and\u002For saliva\u002Fnasal fluid samples at enrollment and again 28 days later.\n\nFor all Components, UCSD will provide PCR test results for SARS-CoV-2, Influenza A\u002FB, and RSV for nasal swab samples.",[119,28,120,121],"Respiratory Infection Virus","RSV","FLU",[123,124,125],"respiratory pathogen testing","vending machine","implementation","2025-10-31",{"date":128,"type":44},"2025-11-04",{"date":130,"type":44},"2025-10-08",{"date":132,"type":22},"2030-10-30",{"name":134,"class":104},"University of California, San Diego",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100609673","clinical-validation-of-the-aptitude-medical-systems-metrix-respiratory-panel-test-in-at-homenon-laboratory-settings-100609673","NCT07217639","Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home\u002FNon-Laboratory Settings","Inclusion Criteria:\n\n1. Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.\n2. Participant is currently exhibiting signs\u002Fsymptoms of respiratory tract infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, new loss of taste or smell, or fatigue. Participant must still be exhibiting symptoms on the day of specimen collection. Days post symptom onset is not to exceed 14 days.\n3. Participant or guardian agrees to read, and is able to read with understanding, the Quick Reference Instructions (QRI) prior to beginning the execution of each of the tests.\n4. Participant or guardian is able and willing to contribute the required swab specimens for testing and understands and is able and willing to sign the study informed consent.\n5. Participant is willing to provide all samples and run tests for the specified investigational devices.\n\nExclusion Criteria:\n\n1. Participant does not understand and\u002For is not able and willing to sign the study informed consent and\u002For assent.\n2. Participant or guardian is not able to comply with nasal swab collection requirements following the Quick Reference Instructions (QRI).\n3. Participant is not currently exhibiting respiratory tract infection symptoms.\n4. Participant has previously participated in the study.\n5. Participant is not able to tolerate specimen collection.\n6. Participant is currently undergoing or has within the past thirty (30) days undergone treatment with prescription medication to treat SARS-CoV-2 infection, including but not limited to Remdesivir (Veklury®), Nirmatrelvir\u002FRitonavir (Paxlovid®), Molnupiravir (LagevrioTM) or receiving convalescent plasma therapy for SARS-CoV- 2.\n7. Participant is currently undergoing or has within the past thirty (30) days undergone an inhaled influenza vaccine (FluMist®), or antiviral treatment, including but not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza®), Amantadine (Symmetrel®), Rimantadine (Flumadine®), or Peramivir (Rapivab®).\n8. Participant is currently undergoing or has within the past thirty (30) days undergone antiviral treatment for RSV, including but not limited to Ribavirin (Virazole®), RSV-IGIV (RespiGam®), Palivizumab (Synagis®), or Nirsevimab-alip (Beyfortus®).\n9. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.\n10. Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.\n11. Participants who do not understand\u002Fread the English language.",{"count":142,"type":22},2000,[89],"The Metrix Respiratory Panel Test will be evaluated for use in Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix Respiratory Panel Test for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in anterior nares (AN) swab samples. Additional sites may be added to the study in order to meet minimum subject\u002Fsample enrollment requirements and geographic prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.",[28,146,147,148,120,149],"Influenza A","Influenza B","Respiratory Synctial Virus","Rhinovirus","2025-10-14",{"date":152,"type":44},"2025-10-16",{"date":154,"type":22},"2025-11-01",{"date":156,"type":22},"2026-09-01",{"name":158,"class":75},"Aptitude Medical Systems",1]