NCT04385251

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,973

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

May 8, 2020

Last Update Submit

August 11, 2022

Conditions

COVIDCOVID19SARS-CoV 2Dyspnea

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Rate of Death at 7 Days

    7 days

  • Rate of Death at 14 Days

    14 days

  • Rate of Death at 28 Days

    28 days

  • Rate of Hospitalization at 7 Days

    7 days

  • Rate of Hospitalization at 14 Days

    14 days

  • +7 more secondary outcomes

Study Arms (1)

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

Interventions

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

SARS-CoV-2 infection/COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- Not currently hospitalized

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Denver Public Health

Denver, Colorado, 80204, United States

Location

Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos

Buenos Aires, C1221ADC, Argentina

Location

CHIP Department of Infectious Diseases

Copenhagen, Denmark

Location

University College London Medical School Centre for Sexual Health and HIV Research

London, England, WC1E, United Kingdom

Location

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.

MeSH Terms

Conditions

COVID-19Dyspnea

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James Neaton, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

June 18, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

US(1)GB(1)AR(1)DK(1)