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.
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
Inclusion Criteria:
- Not currently hospitalized
Exclusion Criteria:
- Persons with a known positive SARS-CoV-2 test > 28 days ago
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
James Neaton, PhD, Principal Investigator
University of Minnesota