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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID, COVID19, SARS-CoV 2, Dyspnea

Intervention / Treatment
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* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Not currently hospitalized Exclusion Criteria: - Persons with a known positive SARS-CoV-2 test > 28 days ago

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 infection/COVID-19<br>Adults who present for SARS-CoV-2 testing will be consented for this study. Participants who are enrolled will be informed that if they have SARS-CoV-2 infection/COVID-19, they will be followed for 28 days in an observational cohort study, and that if they do not have SARS-CoV-2 infection, there will be no further follow-up. | Other: Data Collection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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