SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
COVID-19+6 More
SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection - DiagnosticTest
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help researchers understand how COVID-19 affects people receiving dialysis and what their antibody response is like.

Eligible Conditions
  • COVID-19
  • Covid19

Treatment Effectiveness

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: monthly through study completion (average of 18 months)

Month 18
Communicable Diseases
Incidence of COVID-19 reinfection
Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing
Presence of antibodies in cases of reinfection
Month 6
Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from quantitative and qualitative testing

Trial Safety

Trial Design

1 Treatment Group

Study Cohort
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection · No Placebo Group · N/A

Study Cohort
DiagnosticTest
Experimental Group · 1 Intervention: SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: monthly through study completion (average of 18 months)

Who is running the clinical trial?

Temple UniversityLead Sponsor
267 Previous Clinical Trials
74,134 Total Patients Enrolled
1 Trials studying COVID-19
Dialysis Clinic, Inc.Industry Sponsor
23 Previous Clinical Trials
11,897 Total Patients Enrolled
Avrum Gillespie, MDPrincipal InvestigatorTemple University

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
are more likely to have anemia, hypoalbuminemia, and infection than patients who receive in-center chronic dialysis elsewhere
enrollment and follow study procedures should be offered the opportunity to participate in research

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Dialysis Clinic, Inc.100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%