12/14/2021
Chesapeake Clinical Research is conducting a study for RSV: Pre Study Testing will be a nasal swab that will test for Covid, Flu and RSV curbside.
What is RSV?
Respiratory syncytial virus, or RSV, has
symptoms similar to the common cold, flu,
or COVID. The initial symptoms can include
runny or stuffy nose, sore throat, coughing,
sneezing, and/or fever.
While RSV can cause upper and lower
respiratory illness in everybody, some
people are at a higher risk for developing
more severe RSV disease and RSV-related
complications, as well as being hospitalized.
These high-risk adults include anyone who is
65 years of age or older or has chronic heart
failure, COPD, or asthma.
Researchers in the PRIMROSE study want to assess whether
an investigational RSV medicine is safe and effective for
adults at risk for more severe RSV infection. They want to
compare the investigational medicine to placebo, which looks
like the investigational medicine but does not contain the
active medicine.
The investigational medicine has not been approved to treat
RSV and is available only in research studies like this one. The
results of this study may provide more information about the
investigational medicine when it is given to high-risk adults.
Who is eligible to participate in
the PRIMROSE study?
To pre-qualify for this study, you must:
• Be 18 to 85 years of age
• Have one of the following risk factors for severe RSV
disease and complications: 65 years of age or older,
chronic heart failure, COPD, or asthma
• Not be currently hospitalized
If you are interested, additional criteria will be assessed
by the study doctor. Qualified patients may receive study
medicine and some study-required medical care at
no cost.
As soon as you experience respiratory or cold/flu-like
symptoms or worsening of your underlying symptoms, or
to learn more about the PRIMROSE study, you may contact us
directly.
What will happen during the
PRIMROSE study?
If you are eligible for and agree to participate in this study,
you will be randomly assigned (like rolling the dice) to receive
the investigational medicine or placebo.
You have a 2 in 3 chance (67%) of receiving the investigational
medicine and a 1 in 3 chance (33%) of receiving placebo.
Neither you nor the study doctor/staff will know if you are
receiving the investigational medicine or placebo. However, in
the event of an emergency, this information can be provided.
All patients will take their assigned study medicine
(investigational or placebo) twice a day for 7 days. You may be
asked to visit the study clinic up to 8 times. Some study clinic
visits could take place at your home or be phone calls from
the study doctor/staff.
Total participation in this study will last about 35 days, which
includes screening for eligibility, taking your study medicine,
and follow-up.
What are the benefits and risks
related to the PRIMROSE study?
There is no guarantee you will benefit from participating in
this study. However, your participation could help people with
RSV in the future. By participating in this research, you may
learn more about respiratory infections.
It is possible you could experience side effects while
participating in this study. The study staff will review all
known study-related risks and side effects with you
prior to beginning the study.
Currently, there is no medicine approved to treat RSV
infection in adults. Treatment is limited to caring for
a patient’s symptoms. Consequently, researchers are
searching for other solutions that treat RSV itself.
Please call Chesapeake Clinical Research for more information: 410-931-1966