WGS Analysis of COVID-19 Positive Patients (CALYPSO)

March 20, 2024 updated by: Vanda Pharmaceuticals

Whole Genome Sequencing Analysis of of SARS-CoV-2 Positive Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COVID-19 positive patients

Description

Inclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations with severity and outcomes
Time Frame: 3 months
Clinical associations with human and viral genetics
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-01-01
  • CALYPSO (Other Identifier: Vanda Pharmaceuticals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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