NCT04385251

International SARS-CoV-2 (COVID-19) Infection Observational Study

An International Observational Study of Outpatients With SARS-CoV-2 Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,973 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID
• COVID19
• SARS-CoV 2
• Dyspnea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-18
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2020-05-12
• Last updated: 2022-08-16

Locations

4 sites across 4 countries: United States, Argentina, Denmark, United Kingdom