NCT Number: NCT04385251
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos, Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 28 days
Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
Time frame: 28 days
Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
Time frame: 7 days
Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.
Time frame: 14 days
Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment.
Time frame: 28 days
Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment.
Time frame: 7 days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment.
Time frame: 14 days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment.
Time frame: 28 days
Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment.
Time frame: 7 days
Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment.
Time frame: 14 days
Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment.
Time frame: 28 days
Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Minnesota
Other
An International Observational Study of Outpatients With SARS-CoV-2 Infection
Acronym: ICOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04363268
COVID, COVID-19
Palo Alto, California, United States
View Trial DetailsNCT04756518
COVID, COVID-19
Ipswich, United Kingdom
View Trial DetailsNCT04357834
COVID, COVID 19
Bern, Switzerland
View Trial DetailsNCT04420247
COVID, COVID-19
Curitiba, Paraná, Brazil
View Trial Details