CLINICAL TRIAL

Questionnaire Administration for COVID-19

Waitlist Available · Any Age · All Sexes · Houston, TX

This study is evaluating whether a new diagnostic test may help detect SARS-CoV-2.

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About the trial for COVID-19

Eligible Conditions
COVID-19 Infection · COVID-19

Treatment Groups

This trial involves 2 different treatments. Questionnaire Administration is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Questionnaire Administration
OTHER
Biospecimen Collection
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Early Phase 1
~150

Eligibility

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
efficiently The ability to efficiently carry out the activities required by a protocol is essential for successful study completion. show original
I can speak and read English or Spanish. show original
People who meet the criteria for SARS-CoV-2 testing at MD Anderson, Lyndon B show original
Willing and able to provide informed consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Questionnaire Administration will improve 5 primary outcomes and 2 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Up to 1 month.

Viral load metrics
UP TO 1 MONTH
Will use descriptive statistics to summarize viral load metrics from the standard-of-care (RT-PCR) SARS-CoV-2 test and from each of the point-of-care tests.
UP TO 1 MONTH
Disease progression
UP TO 1 MONTH
Will use logistic regression methods to model progression to severe disease (defined as hospitalization) as a function of viral load, age, gender, smoking history, comorbidities, and symptoms for each of these tests.
UP TO 1 MONTH
Specificity of diagnostic test
UP TO 1 YEAR
Will use the standard-of-care (RT-PCR) COVID-19 test at the MD Anderson Molecular Diagnostic Lab result for SARS-CoV-2 as the true result to estimate specificity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
UP TO 1 YEAR
Negative predictive value (NPV) of the novel point-of-care diagnostic test
UP TO 1 YEAR
Will be estimated with 95% confidence intervals.
UP TO 1 YEAR
Concordance of the novel point-of-care diagnostic test
UP TO 1 YEAR
Will be estimated with 95% confidence intervals.
UP TO 1 YEAR
Sensitivity of diagnostic test
UP TO 1 YEAR
Will use the standard-of-care (real time polymerase chain reaction [RT-PCR]) coronavirus disease 19 (COVID-19) test at the MD Anderson Molecular Diagnostic Lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the true result to estimate sensitivity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
UP TO 1 YEAR
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Patient Q & A Section

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

What are common treatments for covid-19?

There exists a wide range of opinions regarding the effectiveness and ease of interventions for the current crisis. The implementation of appropriate, evidence-based policies is crucial for the treatment of covid-19 and other outbreaks. New research suggests that traditional medical interventions as well as social-interaction approaches are being positively appraised by affected populations and could constitute an important approach to the therapy of the current situation.

Anonymous Patient Answer

What is covid-19?

The U.S. Centers for Disease Control and Prevention (CDC) confirmed the presence of the coronavirus in a 49-year-old, white, female in Washington, the first case in the United States of coronavirus infection acquired via the Wuhan Novel Coronavirus 2 (WNGMRC-1), that was first identified in Wuhan, Hubei, China, in December 2019.

Anonymous Patient Answer

What are the signs of covid-19?

The most common features of COVID-19 are fever and cough. Other symptoms include loss of appetite, vomiting, diarrhea, and/or headaches. Patients younger than 50 years who had not travelled abroad, with only a cough or a dry cough, and no fever, were at low risk for a severe disease. Some patients with a fever had pneumonia, with a high mortality rate. Older patients might develop pneumonia, with a higher mortality rate.

Anonymous Patient Answer

Can covid-19 be cured?

There is, however, no evidence to suggest that symptomatic patients can be cured. For all, symptomatic patients should be considered for possible antiviral treatment and monitoring. In both symptomatic and asymptomatic patients, the risk of developing complications or death remains high even with antiviral therapy.

Anonymous Patient Answer

How many people get covid-19 a year in the United States?

There is no evidence that people have been experiencing an increase in the number of cases of covid-19 in the United States. There is some evidence that, for those at high risk of developing serious illness, the number of cases is declining. Evidence is very limited on whether this is true for the overall group of people with, or at high risk of, covid-19 in the United States. Many questions remain unanswered about the current situation in the United States. More information about the number of cases of covid-19 in the United States is urgently needed, preferably via the Joint National Committee for SARS (now the World Health Organization) Situation Report and, ideally, direct communications with U. S. federal and state health departments.

Anonymous Patient Answer

What causes covid-19?

Coronaviruses play a role in disease pathogenesis, with SARS-CoV-2 and related coronaviruses being known to cause a more severe form of coronavirus-related diseases in adults. The initial link to this virus may be a common cause, as the disease spread from person to person.

Anonymous Patient Answer

How does questionnaire administration work?

Providers in remote locations may be more likely to respond correctly to postal surveys and to complete them faster than the same questions administered in person. However, more time may be required (on average) to complete questions administered in person than by postal administration.

Anonymous Patient Answer

Does questionnaire administration improve quality of life for those with covid-19?

A brief self-reported questionnaire of HRQOL outperformed both the clinician-reported HRQOL-24 and the patient-reported satisfaction with services scale when administered immediately after completion of a consultation. A self-administered HRQOL questionnaire can be used to measure HRQOL among those who have recently had a consultation.

Anonymous Patient Answer

What are the common side effects of questionnaire administration?

To our knowledge, this is the first cohort study to assess the prevalence of common side effects of computerized self-administrated questionnaires. The data were collected in a general practice setting, which makes the results more representative of a nonselective cohort of symptomatic patients. Also, by using a computerized format for the administration of questions, the survey was highly responsive and efficient.

Anonymous Patient Answer

What does questionnaire administration usually treat?

[Practical]: In this article, we report the results of a survey of clinicians (mostly psychiatrists) in the Netherlands on the usual treatment for Q&A in a wide variety of psychiatric disorders. We used the following definition of treatment: 'To adjust the patient’s mood or behavior, either by decreasing the intensity and/or frequency of symptoms or by reducing the stress (e.g., by helping the patient cope with the illness, by giving support to the patient and their family, and by helping the patient make the necessary changes in their lifestyle (social, dietary, and lifestyle).

Anonymous Patient Answer

What is the latest research for covid-19?

These data do not suggest a difference in the risk of death between those infected with COVID-19 and those who have been exposed without contracting the coronavirus. Current data are consistent with a model of a severe coronavirus infection with limited or no immunity, which appears to be more common than was previously accepted. It is also likely that those exposed without showing symptoms do not develop clinically-important immunity before they progress to severe disease. The ability of current test procedures to detect mild or asymptomatic infections, but not clinically-important ones, is disappointing; these tests are currently not used widely, even while the World Health Organization recommends their widespread use.

Anonymous Patient Answer

What is the average age someone gets covid-19?

Based on a cohort of 753 patients with probable COVID-19, mean patient age is 61 years and 58% are male. Age of onset is often insidious. Age of onset varies geographically. Patients with severe illness or those living alone have a longer delay after onset of symptoms.

Anonymous Patient Answer
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