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INSIGHT-011

International SARS-CoV-2 Infection Observational Study (ICOS)

May 5, 2021 by

An International Observational of Outpatients with SARSCoV2 Infection

This is an observational cohort study of outpatients with COVID-19. Enrolment will begin in June 2020 and is expected to continue for at least 12 months. Followup will be 28 days from enrolment in those who are positive. Those with a negative test will not be followed, after enrolment or disclosure of a negative result.

Study Objectives

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.

Endpoints

The primary endpoint is hospitalization or death during the 28 day follow-up period. Special facilities are being built for the care of COVID-19 patients requiring medical care. 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 enrolment.

Key secondary outcomes include:

• Participant-reported evaluation of health status

• Change in severity of dyspnoea.

Tagged With: insight-011, study

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