Study Summary
This trial is testing the efficacy of baloxavir marboxil in reducing the spread of influenza within households.
- Influenza
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: Baseline to Day 9 (9 Days)
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Baloxavir Marboxil
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
3160 Total Participants · 2 Treatment Groups
Primary Treatment: Baloxavir Marboxil · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 5 - 64 · All Participants · 21 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 44.4% |
| Alabama | 33.3% |
| North Carolina | 11.1% |
| Other | 11.1% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Central Alabama Research; Pediatrics | 16.7% |
| Cahaba Research, Inc. | 33.3% |
| Long Beach Clinical Trials | 16.7% |
| Other | 33.3% |
What portion of applicants met pre-screening criteria?
| Met criteria | 62.5% |
| Did not meet criteria | 37.5% |
How many prior treatments have patients received?
| 0 | 50.0% |
| 3+ | 50.0% |
Why did patients apply to this trial?
- "Prozac, anti depressants,"
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Cahaba Research, Inc.: < 24 hours
Average response time
- < 1 Day
- Komeda, Takuji, Takahiro Takazono, Naoki Hosogaya, Eriko Ogura, Masakazu Fujiwara, Hideyuki Miyauchi, Yoshikazu Ajisawa, et al.. 2020. “Comparison of Household Transmission of Influenza Virus from Index Patients Treated with Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciaa1622.
- 2019. "Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03969212.
Frequently Asked Questions
Could you please give an estimate of how many people are being used as test subjects in this experiment?
"Yes, that is accurate. The listing on clinicaltrials.gov shows that this study began recruiting patients on October 10th, 2019 and is still ongoing. Currently, 3160 individuals are needed from a total of 41 sites." - Anonymous Online Contributor
Is this research the first to study this topic?
"Baloxavir Marboxil is being studied in 4 active clinical trials taking place in 91 cities and 26 countries. The first trial began in 2019 and was sponsored by Hoffmann-La Roche. Only 30 patients were needed for the Phase 3 drug approval stage. Since then, 18294 studies have been completed." - Anonymous Online Contributor
Are people still being signed up for this experiment?
"You're correct, the trial is recruiting patients right now. The listing on clinicaltrials.gov shows that the trial was posted on October 10th, 2019 and last updated October 27th, 2020." - Anonymous Online Contributor
Is this research being conducted with middle-aged adults?
"This trial's inclusion criteria includes a minimum age of 5 and a maximum age of 64." - Anonymous Online Contributor
How can I sign up to participate in this research project?
"Eligible individuals for this study are those that have influenza, are human, and between the ages of 5-64. A total of 3160 people are required for the study." - Anonymous Online Contributor
Are there any potential dangers in taking Baloxavir Marboxil?
"Baloxavir Marboxil is Phase 3, meaning that while there is data supporting efficacy, multiple rounds of data are needed to support safety." - Anonymous Online Contributor
In how many different geographical areas is this research being conducted?
"There are 41 trial sites currently operational, located in Mishawaka, Houston, Miami, and other locations." - Anonymous Online Contributor
What has been the general response to Baloxavir Marboxil in other scientific investigations?
"Currently, there are 4 ongoing trials investigating the efficacy of Baloxavir Marboxil. 3 of these trials are in Phase 3. Most of the clinical trials for Baloxavir Marboxil are located in Berazategui, Massachusetts; however, there are 350 total locations conducting studies on this medication." - Anonymous Online Contributor