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Antigen Test

Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab) for COVID-19

Phase 1
Waitlist Available
Led By Niraj Lodhi, PhD
Research Sponsored by Testing Done Simple
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights

Study Summary

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity
Specificity
Secondary outcome measures
Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects

Trial Design

2Treatment groups
Experimental Treatment
Group I: Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)Experimental Treatment1 Intervention
Group II: Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testing Done Simple SARS CoV-2 Antigen Test
2022
Completed Phase 1
~180

Find a Location

Who is running the clinical trial?

Testing Done SimpleLead Sponsor
Nao Medical Urgent CareUNKNOWN
Niraj Lodhi, PhDPrincipal InvestigatorTesting Done Simple

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA sanctioning Testing Done Simple's Antigen test in symptomatic patients via nasal swabbing?

"This Phase 1 trial has limited evidence of both efficacy and safety, so it was allocated a score of 1 on our scale."

Answered by AI

Are there still open spots in this medical research venture?

"Affirmative. Clinicaltrials.gov houses records which attest to the fact that this research endeavour, initially posted on November 4th 2022, is now seeking participants. Two sites are accepting a total of 300 patients."

Answered by AI

What is the total cohort size for this experimental protocol?

"Affirmative. Clinicaltrials.gov details this clinical trial as actively recruiting participants, which was originally posted on November 4th 2022 and modified most recently on the 7th of that same month. 300 individuals are being sought by 2 different medical centres for enrolment in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
2022. "Assessing Performance of the Testing Done Simple Covid 19 Antigen Test". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610449.
~71 spots leftby Apr 2025
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