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

Completed

• Conditions: SARS-CoV 2; Dyspnea; COVID19; COVID

• Registration Number: NCT04385251
• Lead Sponsor: University of Minnesota

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-06-18
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11973

Inclusion Criteria

• Not currently hospitalized

Exclusion Criteria

• Persons with a known positive SARS-CoV-2 test > 28 days ago

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Expiration	28 days	Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
Time to Hospitalization	28 days	Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.

Secondary Outcome Measures

Name	Time	Method
Rate of Hospitalization at 28 Days	28 days	Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment.
Participant Health at 7 Days	7 days	Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment.
Rate of Hospitalization at 7 Days	7 days	Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment.
Rate of Hospitalization at 14 Days	14 days	Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment.
Participant Health at 14 Days	14 days	Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment.
Modified Borg Dyspnea Scale at 7 Days	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.
Modified Borg Dyspnea Scale at 14 Days	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.
Modified Borg Dyspnea Scale at 28 Days	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.
Rate of Death at 14 Days	14 days	Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment.
Rate of Death at 28 Days	28 days	Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment.
Participant Health at 28 Days	28 days	Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment.
Rate of Death at 7 Days	7 days	Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.

Trial Locations

Locations (4)

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