NCT04353401

Brief Summary

We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

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

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

April 15, 2020

Last Update Submit

March 20, 2024

Conditions

Coronavirus InfectionCOVID-19

Keywords

Covid-19WGSviral loadviral genome

Outcome Measures

Primary Outcomes (1)

  • Associations with severity and outcomes

    Clinical associations with human and viral genetics

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 positive patients

You may qualify if:

  • Ability and acceptance to provide written informed consent and fluent in English.
  • Men or women between 18-100+ years, inclusive.
  • Willing to comply with study procedures.
  • SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

August 3, 2020

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)