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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODVIR0001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants at High Risk for Poor Outcomes From a Respiratory Infection | Data will be collected for participants at high risk for poor outcomes from a respiratory infection. The duration of participation per participant will be up to 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is an observational study to assess the incidence and key disease characteristics of symptomatic acute respiratory viral infections in a high-risk population at risk for poor outcomes. Duration of each participant will be up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinically Confirmed Acute Respiratory Infection (ARI) | Number of participants with clinically confirmed ARI will be reported. | Up to 1 year 3 months |
| Number of Clinically Confirmed ARI Participants With Positive or Negative Infection Status for Each Respiratory Virus Tested | Number of clinically confirmed ARI participants with positive or negative infection status for each respiratory virus tested will be reported. | Up to 1 year 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinically Confirmed ARI Participants who Were Hospitalized | Number of clinically confirmed ARI participants who were hospitalized will be reported. | Up to 1 year 3 months |
| Number of Clinically Confirmed ARI Participants who Experienced Complications |
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Inclusion Criteria:
Exclusion Criteria:
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Participants at high risk for severe respiratory infections due to their immune-suppressive status.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Palo Alto | California | 94305 | United States | ||
| Henry Ford Hospital |
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Serum, whole blood and nasosorption samples will be collected to retain DNA if required.
Number of clinically confirmed ARI participants who experienced complications will be reported. |
| Up to 1 year 3 months |
| Number of Deaths in Clinically Confirmed ARI Participants | Number of deaths in clinically confirmed ARI participants will be reported. | Up to 1 year 3 months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Fred Hutchinson Research Center | Seattle | Washington | 98109 | United States |
| Hamilton Health Sciences | Hamilton | Ontario | L8L8E7 | Canada |