An observational study in COVID, COVID19 and SARS-CoV 2, sponsored by University of Minnesota. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by University of Minnesota · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 11,973 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who test positive for SARS-CoV-2 infection/COVID-19 will be followed for 28 days in an observational cohort study.
Exclusion Criteria:
Adults who present for SARS-CoV-2 testing will be consented for this study. Participants who are enrolled will be informed that if they have SARS-CoV-2 infection/COVID-19, they will be followed for 28 days in an observational cohort study, and that if they do not have SARS-CoV-2 infection, there will be no further follow-up.
Other: Data 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
Time to Hospitalization
Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
Time frame: 28 days
Time to Expiration
Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
Time frame: 28 days
Rate of Death at 7 Days
Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.
Time frame: 7 days
Rate of Death at 14 Days
Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment.
Time frame: 14 days
Rate of Death at 28 Days
Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment.
Time frame: 28 days
Rate of Hospitalization at 7 Days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment.
Time frame: 7 days
Rate of Hospitalization at 14 Days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment.
Time frame: 14 days
Rate of Hospitalization at 28 Days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment.
Time frame: 28 days
Participant Health at 7 Days
Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment.
Time frame: 7 days
Participant Health at 14 Days
Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment.
Time frame: 14 days
Participant Health at 28 Days
Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment.
Time frame: 28 days
Modified Borg Dyspnea Scale at 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.
Time frame: 7 Days
Modified Borg Dyspnea Scale at 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.
Time frame: 14 Days
Modified Borg Dyspnea Scale at 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.
Time frame: 28 Days
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