International SARS-CoV-2 (COVID-19) Infection Observational Study
- Conditions
- SARS-CoV 2DyspneaCOVID19COVID
- Interventions
- Other: Data Collection
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11973
- Not currently hospitalized
- Persons with a known positive SARS-CoV-2 test > 28 days ago
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV-2 infection/COVID-19 Data Collection 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.
- Primary Outcome Measures
Name Time Method Time to Hospitalization 28 days Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
Time to Expiration 28 days Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (4)
Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos
π¦π·Buenos Aires, Argentina
Denver Public Health
πΊπΈDenver, Colorado, United States
University College London Medical School Centre for Sexual Health and HIV Research
π¬π§London, England, United Kingdom
CHIP Department of Infectious Diseases
π©π°Copenhagen, Denmark