ICOS (An International Observational Study of Outpatients With SARS-CoV-2 Infection) is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 who have been assessed as not requiring hospitalization (outpatients). The study reflects 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 study will also be a platform for the screening of outpatients for randomized trials that will be conducted by the INSIGHT group.
The general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. Secondary outcomes include participant-reported health status and change in severity of dyspnoea.
Among those who test positive for SARS-CoV-2 at screening, the two primary objectives of this observational study are:
1. Estimate the rate of hospitalization or death during the 28 day follow-up period.
2. Identify risk factors for hospitalization or death.
Adults who seek testing for SARS-CoV-2 will be screened following consent. 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 enrolment of a large number of adults at INSIGHT sites around the world.
Four sites/countries are enrolling participants in the pilot phase of ICOS:
• Argentina (Buenos Aires)
• Denmark (Copenhagen)
• United Kingdom (London)
• United States (Denver)
Estimated study period: 15th of June 2020 – 30th of June 2021.
Estimated enrolment: 10000 participants.
As the understanding of the natural history of COVID-19 improves based on this and other studies, inclusion criteria and the data collection plan, including the outcomes assessed in this protocol, may be modified.
For further details about the ICOS study, please visit the INSIGHT website.
For more information about the ICOS Study at Copenhagen ICC, please contact firstname.lastname@example.org.