COVID, COVID19, Dyspnea, SARS-CoV 2
Conditions
Brief summary
The general aim of this study is to estimate the rate of disease progression for adults testing positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-CoV-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment. Secondary outcomes include participant-reported health status and change in severity of dyspnoea.
Detailed description
SARS-CoV-2 is a coronavirus that emerged in China in late 2019 causing a novel Corona-Virus Induced Disease (COVID-19). COVID-19 is spreading rapidly throughout the world. While a proportion of people with COVID-19 have sufficiently severe symptoms to require hospitalization at the time of initial symptom onset, in others the disease may remain mild, and in some cases there has been observed a worsening of symptoms a few days after initial presentation with relatively mild symptoms. There is an urgent need for understanding the progression of disease for individuals with SARS-CoV-2 infection/COVID-19 who do not require immediate hospitalization. This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 managed as outpatients (not hospitalized). This study will also be a platform for the enrollment of outpatients for randomized trials that will be conducted by the INSIGHT group. Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. Procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at INSIGHT sites around the world.
Interventions
OTHERData Collection
DATA COLLECTION AT ENROLLMENT: Demographics; Symptoms and health status; Co-morbidities; Targeted medications; Specimen Collection (substudy at selected sites): Upper respiratory swab, blood for serum storage. DATA COLLECTION AT DAYS 7, 14 & 28: Vital and hospitalization status; Symptoms and health status
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Not currently hospitalized
Exclusion criteria
\- Persons with a known positive SARS-CoV-2 test \> 28 days ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospitalization | 28 days | Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19. |
| Time to Expiration | 28 days | Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Death at 28 Days | 28 days | Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment. |
| Rate of Hospitalization at 7 Days | 7 days | Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment. |
| Rate of Hospitalization at 14 Days | 14 days | Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment. |
| Rate of Hospitalization at 28 Days | 28 days | Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment. |
| Participant Health at 7 Days | 7 days | Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment. |
| Rate of Death at 7 Days | 7 days | Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment. |
| Participant Health at 28 Days | 28 days | Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment. |
| Modified Borg Dyspnea Scale at 7 Days | 7 Days | The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 7 days post enrollment. |
| Modified Borg Dyspnea Scale at 14 Days | 14 Days | The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 14 days post enrollment. |
| Modified Borg Dyspnea Scale at 28 Days | 28 Days | The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 28 days post enrollment. |
| Participant Health at 14 Days | 14 days | Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment. |
| Rate of Death at 14 Days | 14 days | Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment. |
Countries
Argentina, Denmark, United Kingdom, United States
Outcome results
None listed