The Horror!
Cold and flu season can make you feel like a zombie.
This study is evaluating an investigational drug to see if it can protect against viral respiratory illnesses.
SEE IF YOU MAY QUALIFY
The POSITS Study is testing whether the investigational drug INNA-051 can lower the chances of getting sick or reduce the severity of symptoms from viral respiratory infections —such as cold or flu. It's focused on healthy individuals who might be exposed to cold viruses. Participants in the POSITS Study will use a powder nasal spray system weekly to take the investigational drug, which is designed to boost the body’s response to viral infections at the site of entrance to the body and prevent or reduce illness. The first 200 participants enrolled will be placed in Part A of the study and the following 900 participants enrolled will be placed in Part B.
If you qualify and decide to take part, you may receive at no cost:
- Access to the investigational drug in a powder nasal spray system, which is being studied for its potential to reduce the severity of respiratory viral illness
- Study-related care and monitoring by qualified site staff
- A paid stipend for completed visits and electronic diaries
You may also be helping to keep the public healthier through your participation.
To participate in this study, you must be:
- From 18 through 45 years of age
- Healthy (without significant medical or psychiatric conditions)
- At risk for exposure to viral respiratory infections, such as:
- Living in a crowded household, university dorm, or military barracks
- Working at a childcare center
- Living with children aged 10 or younger attending school or daycare
- Job-related exposure such as healthcare workers, factory workers, taxi and bus drivers, grocery clerks, and educators or counselors working in crowded environments or with multiple exposures with different people daily
Other requirements need to be met to join the POSITS Study.
Baseline Period (4 weeks):
Collection of weekly nasal swabs will be required for potential testing. Depending on when you join the study, your nasal swabs may be taken at a testing site or at home. During this time, eligible participants:
- Download a study smartphone app to watch brief educational study videos or watch on a study website
- Only smartphone app responses will be collected (no other information will be shared).
- The smartphone app information you provide here will only be used for study purposes
- Answer questions about respiratory symptoms in the app each day
- Undergo safety lab tests and a body temperature check
Treatment Period (PART A 4 or PART B 12 weeks):
Participants (up to 1100) who adhere to study procedures and meet eligibility criteria during the baseline period will be randomly selected (like tossing a coin) to receive INNA-051 (300 μg/nostril) or an inactive investigational drug (placebo) as a powder using a nasal spray system, once weekly. There is a 50% chance you will be taking the investigational drug and a 50% chance you will be taking placebo. In addition to weekly investigational drug or placebo powder nasal spray system use, the treatment period involves:
- Completing a daily symptom e-diary in the app
- Providing a weekly nasal swab (done at your site if assigned to part A or self swab if assigned to part B) to test for virus infection
- Answering questions about nasal irritation 24 and 48 hours after giving yourself the investigational powder nasal spray
- Taking additional nasal self-swabs and recording body temperature if you develop cold symptoms
- Providing blood samples for laboratory testing
Follow-up Period (4 weeks):
After the treatment period, there is an additional 4-week follow-up period involving follow-up by your study site.
Visit frequency and location depend on whether you are in Part A or Part B.
Visits during treatment. Some of the visits listed below may be Telehealth visits (remote appointment via phone call:
- Part A weekly, on days 1, 8, 15, 22, and 29
- Part B: on days 1, 22, 29, 50, 57, and 85
Study duration: The maximum expected time that participants will be involved in the study is about 20 weeks, as follows:
- Baseline: 4 weeks
- Treatment: 12 weeks
- Post-treatment follow-up: 4 weeks
It's important to reduce the impact of respiratory viral illnesses because they're a major cause of serious complications worldwide, including hospitalizations and death, particularly in older patients or those with other medical conditions. For young adults, especially college students or military personnel living in shared spaces, daycare center workers, those living closely with others, and those living with or caring for young children, the risk of exposure to viral infections is higher. Living in shared bedrooms, dorms, or barracks as well as working or studying in classrooms or childcare centers can make it easier for viruses to spread.
Frequently asked questions
During a clinical study, you’ll receive the investigational medication that is being studied. This will be done at scheduled times throughout the study, depending on the medication. If you participate, you may also have procedures performed to monitor your health, such as, blood work or other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication, but instead receive a placebo. All study volunteers are closely monitored by clinic staff and the medical team to ensure their safety.
Placebo: A placebo looks like the investigational drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time and for any reason.
Eligible participants will self-administer the study drug, or placebo (an inactive substance which resembles the study drug) once weekly. Detailed instruction to administer the study drug will be provided by site staff and may be viewed here:
Instructions for Use: Unidose Powder Nasal Spray
ENA Respiratory PTY LTD may provide a stipend upon completing study-related tasks. There may also be reimbursement for some study-related travel and expenses. For more information, please speak with a member of the study team during your study visits.
You’ll first be asked some general questions (here) that help us determine whether you meet the basic criteria of the study. If you do meet these basic criteria, you may be asked to download the smartphone app to continue participation. Instructional videos and symptom questions are part of the app for you to use during the POSITS Study.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by possibly receiving a new treatment for an ongoing disease or condition. In the POSITS Study, your participation will help by identifying a potential medicine that could help keep people healthy by reducing symptom severity from viral respiratory infections.
Participants like you really help make a difference.
Every clinical trial must be reviewed and is continually monitored by an ethics review committee and regulatory bodies (for example, the United States FDA) to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
ENA Respiratory PTY LTD is responsible for conducting this clinical study.
