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.
Study Type
OBSERVATIONAL
Enrollment
11,973
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
Denver Public Health
Denver, Colorado, United States
Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos
Buenos Aires, Argentina
CHIP Department of Infectious Diseases
Copenhagen, Denmark
University College London Medical School Centre for Sexual Health and HIV Research
London, England, United Kingdom
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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