Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants age 18-34 | Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview. |
| |
| Participants age 35-54 | Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
| |
| Participants age 55-64 | Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
| |
| Participants 65 and over | Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Antibody Analysis | Diagnostic Test | 10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit | All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire. | At study start |
| Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit | Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks. | At 4 weeks |
| Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit | Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months. | At 3 months |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Community Sample
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna R Giuliano, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
Not provided
| Label | URL |
|---|---|
| Moffitt Cancer Center's Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Weck-cel Swab Collection | Diagnostic Test | A Weck-cel swab will be used to collect secretions from the mucosal epithelium |
|
| Web Based Questionnaire | Behavioral | A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications. |
|
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |