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

COVID19 Clinical Trial

— ICOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385251
• Other study ID #: ICOS
• Secondary ID: 75N91019D00024
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11973
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not currently hospitalized

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID
• COVID-19
• COVID19
• Dyspnea
• SARS-CoV 2

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos	Buenos Aires
Denmark	CHIP Department of Infectious Diseases	Copenhagen
United Kingdom	University College London Medical School Centre for Sexual Health and HIV Research	London	England
United States	Denver Public Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Argentina,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hospitalization	Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.	28 days
Primary	Time to Expiration	Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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