NCT04568148

Brief Summary

Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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
Same day until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

April 15, 2020

Last Update Submit

July 29, 2025

Conditions

Covid-19SARS-CoV 2CoronavirusCOVID

Outcome Measures

Primary Outcomes (3)

  • Biospecimen Collection

    Establish a collection of biospecimens from patients with COVID-19.

    From Enrollment to 3 Months

  • Establishing Connections

    Establish a link between biospecimens and longitudinal individual patient data

    From Enrollment to 3 Months

  • Continuing COVID Research

    Provide biospecimens and unique patient data to researchers investigating COVID-19

    From Enrollment to 3 Months

Eligibility Criteria

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

COVID-19-positive patients

You may qualify if:

  • The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
  • The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR.
  • Patient is 18 years of age or older.

You may not qualify if:

  • Participant declines to participate (living patients only)
  • Participant or healthcare surrogate is unable to provide informed consent (living patients only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens to be collected include serum and plasma. Blood samples will be collected, processed, aliquoted, and stored at -80°C. A portion of the blood samples will be kept for DNA and RNA isolation.

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Leslie A Spikes, MD

    Assistant Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

September 29, 2020

Study Start

April 15, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

US(1)