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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; COVID; COVID19; Dyspnea
• Intervention / Treatment: Other: Data Collection

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 Type: Observational
• Enrollment (Actual): 11973

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1221ADC
    • Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos
• Denmark
  • Copenhagen, Denmark
    • CHIP Department of Infectious Diseases
• United Kingdom
  • England
    • London, England, United Kingdom, WC1E
      • University College London Medical School Centre for Sexual Health and HIV Research
• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants who test positive for SARS-CoV-2 infection/COVID-19 will be followed for 28 days in an observational cohort study.

Description

Inclusion Criteria:

- Not currently hospitalized

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SARS-CoV-2 infection/COVID-19; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2020
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Dyspnea
• Other Study ID Numbers: ICOS; 75N91019D00024 (OTHER_GRANT: Leidos Biomedical Research, Inc.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No