Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Swab Sample · 1 trial · 1 indication
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Number of participants with relative risk of ARI-related hospitalization in participants positive for RSV with LRTD or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the Respiratory Infection Intensity and Impact Questionnaire (RiiQTM) V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
| Arm | Type | Description |
|---|---|---|
| Participants with Acute Respiratory Infections (ARI) in Outpatient Setting | OTHER | Participants presenting with ARIs in an outpatient setting who are at high risk of progressing to severe disease will be screened for viral respiratory pathogens (respiratory syncytial virus \[RSV\], Influenza, severe acute respiratory syndrome coronavirus 2 \[SARS-COV-2\]) by collecting a nasal swab. If a participant is positive for RSV and/or influenza virus and/or SARS-CoV-2 based on a study test or standard-of-care (SOC) polymerase chain reaction (PCR)-based test, the participant will be eligible for enrollment in the study in the home-based short-term and long-term follow-up phases. |
| Name | Type | Description |
|---|---|---|
| Nasal Swab Sample | DIAGNOSTIC_TEST | Nasal swab sample will be used to screen participants for detection of viral pathogens. No intervention or study drug will be administered as part of this study. |
Inclusion Criteria: * Present to the general physician (GP)/specialist outpatient settings/respiratory clinics or in Emergency department (ED) settings with symptoms suggestive of a diagnosis of Acute Respiratory Infections (ARI) * For inclusion in the home-based follow-up phases, must test positiv...
Swab Sample is an investigational product being studied for use in acute respiratory infection. It is in early Phase 1 clinical development, and the completed trial enrolled 245 adults across multiple countries. The product is not approved and remains under investigation.
Swab Sample is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The investigational product is currently in early Phase 1 clinical development for acute respiratory infection.
Swab Sample is in early Phase 1 clinical development. One trial, NCT05148780, has been completed. The product is investigational and has not been approved for any use.
Swab Sample has one completed clinical trial, NCT05148780, titled 'A Study of Acute Respiratory Infections in Global Outpatient Setting.' The trial enrolled 245 adults with acute respiratory infection and was conducted in the United States, Canada, France, Japan, Malaysia, Poland, South Korea, Spain, Taiwan, and the United Kingdom.
Swab Sample is not FDA approved. It is an investigational product in early Phase 1 clinical development for acute respiratory infection. The completed trial NCT05148780 was an uncontrolled study, and the product remains under clinical investigation.