COVIDICOSNCT04385251
International SARS-CoV-2 (COVID-19) Infection Observational Study
An observational study of COVID and COVID19, run by University of Minnesota at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, COVID19, SARS-CoV 2
- What is being tested?
- Data Collection
- How many people
- 11,973 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 18 Jun 2020to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who test positive for SARS-CoV-2 infection/COVID-19 will be followed for 28 days in an observational cohort study.
Who may be able to join
- Not currently hospitalized
Who cannot join
- Persons with a known positive SARS-CoV-2 test > 28 days ago
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Argentina1 site
Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos
Buenos Aires, C1221ADC
United Kingdom1 site
University College London Medical School Centre for Sexual Health and HIV Research
London, England, WC1E
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID, COVID19, SARS-CoV 2, Dyspnea
- Being tested
- Data Collection
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hospitalization
Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
Measured: 28 days
Time to Expiration
Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
Measured: 28 days
Secondary outcomes (12)
Rate of Death at 7 Days
Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start18 Jun 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- James Neaton, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385251
- Sponsor's protocol ID
- ICOS
- Other IDs
- 75N91019D00024
- Acronym
- ICOS
- Status last verified
- Aug 2022
- First submitted
- 8 May 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Observational Study of Outpatients With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04385251
- Acronym / sponsor ID
- ICOS / ICOS
- Conditions
- COVID, COVID19, SARS-CoV 2, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,973 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 infection/COVID-19 | – | Other: Data CollectionAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who test positive for SARS-CoV-2 infection/COVID-19 will be followed for 28 days in an observational cohort study.
Key inclusion criteria (1 listed)
- Not currently hospitalized
Key exclusion criteria (1 listed)
- Persons with a known positive SARS-CoV-2 test > 28 days ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionDATA 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 | Other | SARS-CoV-2 infection/COVID-19 |
Primary outcome
Time to Hospitalization
Time frame: 28 days
Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.
Time to Expiration
Time frame: 28 days
Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.
12 secondary outcomes
Rate of Death at 7 Days
Time frame: 7 days
Rate of Death at 14 Days
Time frame: 14 days
Rate of Death at 28 Days
Time frame: 28 days
Rate of Hospitalization at 7 Days
Time frame: 7 days
Rate of Hospitalization at 14 Days
Time frame: 14 days
Rate of Hospitalization at 28 Days
Time frame: 28 days
Participant Health at 7 Days
Time frame: 7 days
Participant Health at 14 Days
Time frame: 14 days
Participant Health at 28 Days
Time frame: 28 days
Modified Borg Dyspnea Scale at 7 Days
Time frame: 7 Days
Modified Borg Dyspnea Scale at 14 Days
Time frame: 14 Days
Modified Borg Dyspnea Scale at 28 Days
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Neaton, PhD principal investigator
University of Minnesota
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and COVID19, run by University of Minnesota at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Argentina, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hospitalization (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.