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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385251
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.


Condition or disease Intervention/treatment
COVID COVID19 SARS-CoV 2 Dyspnea 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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Study of Outpatients With SARS-CoV-2 Infection
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time to Hospitalization [ Time Frame: 28 days ]
    Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.

  2. Time to Expiration [ Time Frame: 28 days ]
    Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.


Secondary Outcome Measures :
  1. Rate of Death at 7 Days [ Time Frame: 7 days ]
    Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.

  2. Rate of Death at 14 Days [ Time Frame: 14 days ]
    Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment.

  3. Rate of Death at 28 Days [ Time Frame: 28 days ]
    Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment.

  4. Rate of Hospitalization at 7 Days [ Time Frame: 7 days ]
    Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment.

  5. Rate of Hospitalization at 14 Days [ Time Frame: 14 days ]
    Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment.

  6. Rate of Hospitalization at 28 Days [ Time Frame: 28 days ]
    Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment.

  7. Participant Health at 7 Days [ Time Frame: 7 days ]
    Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment.

  8. Participant Health at 14 Days [ Time Frame: 14 days ]
    Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment.

  9. Participant Health at 28 Days [ Time Frame: 28 days ]
    Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment.

  10. Modified Borg Dyspnea Scale at 7 Days [ 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.

  11. Modified Borg Dyspnea Scale at 14 Days [ 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.

  12. Modified Borg Dyspnea Scale at 28 Days [ 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.


Biospecimen Retention:   Samples With DNA
At the time of enrollment, selected sites participating in a sub-study will be asked to obtain separate consents for 1) an upper respiratory swab and a blood sample sufficient for four 1mL transport tubes of serum to be shipped to a central repository for future research on COVID-19; and 2) co-enrollment in the INSIGHT Genomics Study (INSIGHT 004) where a blood sample sufficient for six 1mL aliquots of whole blood will be collected. These specimens will be sent to a central repository in the United States for storage.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

- Not currently hospitalized

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385251


Contacts
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Contact: Eileen Denning 612-626-8049 edenning@umn.edu

Locations
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United States, Colorado
Denver Public Health Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Edward Gardner         
Argentina
Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos Not yet recruiting
Buenos Aires, Argentina, C1221ADC
Principal Investigator: Marcelo Losso         
Denmark
CHIP Department of Infectious Diseases Recruiting
Copenhagen, Denmark
Principal Investigator: Jens Lundgren         
United Kingdom
University College London Medical School Centre for Sexual Health and HIV Research Recruiting
London, England, United Kingdom, WC1E
Principal Investigator: Sarah Pett         
Sponsors and Collaborators
University of Minnesota
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: James Neaton, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04385251    
Other Study ID Numbers: ICOS
75N91019D00024 ( Other Grant/Funding Number: Leidos Biomedical Research, Inc. )
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory