Clinical trial NCT04385251: International SARS-CoV-2 (COVID-19) Infection Observational Study
Official title: An International Observational Study of Outpatients With SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
COVID19
SARS-CoV 2
Dyspnea
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-05-12
Enrollment: 11973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

- Not currently hospitalized

Exclusion Criteria:

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

Primary outcomes:
measure: Time to Hospitalization
timeFrame: 28 days
measure: Time to Expiration
timeFrame: 28 days
Secondary outcomes:
measure: Rate of Death at 7 Days
timeFrame: 7 days
measure: Rate of Death at 14 Days
timeFrame: 14 days
measure: Rate of Death at 28 Days
timeFrame: 28 days
measure: Rate of Hospitalization at 7 Days
timeFrame: 7 days
measure: Rate of Hospitalization at 14 Days
timeFrame: 14 days
measure: Rate of Hospitalization at 28 Days
timeFrame: 28 days
measure: Participant Health at 7 Days
timeFrame: 7 days
measure: Participant Health at 14 Days
timeFrame: 14 days
measure: Participant Health at 28 Days
timeFrame: 28 days
measure: Modified Borg Dyspnea Scale at 7 Days
timeFrame: 7 Days
measure: Modified Borg Dyspnea Scale at 14 Days
timeFrame: 14 Days
measure: Modified Borg Dyspnea Scale at 28 Days
timeFrame: 28 Days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Public Health
state: Colorado
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos
city: Copenhagen
country: Denmark
facility: CHIP Department of Infectious Diseases
city: London
country: United Kingdom
facility: University College London Medical School Centre for Sexual Health and HIV Research
state: England
Study officials:
affiliation: University of Minnesota
name: James Neaton, PhD
role: PRINCIPAL_INVESTIGATOR
References: