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

NCT04385251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11973

Last updated 2022-08-16

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • James Neaton, PhD · University of Minnesota

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States
  • Argentina
  • Denmark
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385251 on ClinicalTrials.gov