To Our Volunteers

COVID Protocol 

We have outlined a plan for our study volunteers to minimize direct contact and thereby potential COVID-19 exposure.

Prior To Visit At RCR

Each study participant coming in for an in-office visit will receive a text message approximately 24 hours prior asking them the COVID QUESTIONAIRE. (see below)

They will be instructed to contact the research office if this information changes between the text message and appointment. They will also be reminded that visitors accompanying them to their study appointment will need to wait outside the office and should not enter the waiting room.

 

Upon Entry To RCR

-When checking in we ask that patients social distance and check in one at a time.

– Their temperature will be checked, mask given if necessary. If temperature is under 100F will be seated in socially distanced waiting room and escorted to an exam room as quickly as possible.

– They will be REQUIRED to:

– Wash and sanitize their hands upon entry to the waiting room/monitor area.

– Leave mask on at all times

– Use their own pen at all times (provided if needed)

– Sanitize hands before and after touching any charts, printer, doorknobs etc.

-Report any COVID like symptoms or diagnosis to RCR after leaving the office for up to two weeks

COVID QUESTIONAIRE

If Yes to any of the following, notify charge staff for provider review to determine if appointment will proceed today- subject to wait in hallway.

  1. Have you or a close personal contact tested positive for COVID-19? If yes, how long ago? More than 2 weeks, ok to have visit.
  2. Do you have any of the following symptoms:
  • fever (temp over 99 degrees F),
  • cough, shortness of breath,
  • extreme fatigue,
  • body aches,
  • loss of taste or smell,
  • nausea, vomiting or diarrhea?
  1. Do any of your close contacts including members of your household have any of the following symptoms: fever (temp over 100 degrees F), cough, shortness of breath, extreme fatigue, body aches, loss of taste or smell, nausea, vomiting or diarrhea?
  2. Have you recently within 2 weeks traveled to an area where you feel you could have been exposed to COVID-19? NYC, Nursing home, hospital, friend or family members home who is symptomatic or tested positive?
  3. Have you or any members of your household traveled to any of the NY travel advisory states in the past 2 weeks?
  4. Please contact RCR if this information changes.
  5. Visitors accompanying them to their visit will need to remain in the car and not enter the building.
  6. Please call RCR 585-288-0890 when you arrive at the parking lot for further instructions. Wear a mask if you have one, if not we will provide one.

To Potential COVID-19 Vaccine Trial Participants

Interested in participating in a COVID-19 vaccine trial? The availability of the new COVID-19 vaccine for emergency use is a tribute to many volunteers such as yourself and shows how important voluntary participation is in vaccine research. As these newly authorized vaccines are rolled out to the public, the following information may help answer some questions you have about what this means for you as a COVID-19 clinical trial participant.

What is the status of the EUA vaccines in the US?

The vaccines that have been granted Emergency Use Authorization (EUA) by the FDA (2 so fat, others are likely on the way) have been determined by the FDA to offer a degree of benefit of protection against COVID-19 disease that outweighs anticipated risk of vaccines. It is important to note that EUA is not the same as FDA “approval”, as additional data (usually longer-term safety data) are required for full regulatory approval.

Because the vaccines are in limited supply at this time, they are recommended by the US Centers for Disease Control and Prevention initially for individuals who are at a particularly high risk of acquiring or developing complications of COVID-19; that is healthcare workers and residents and staff of long-term care facilities. Some states’ governors have expanded the availability to broader populations to speed their statewide vaccination programs. You should talk with your healthcare provider or the study staff to determine whether and when an EUA vaccine is likely to be available to you in your location.

Are more vaccine trials needed?

The simple answer is Yes. Additional vaccines will be required to meet the global needs to combat the SARS CoV-2 virus (coronavirus) because no single vaccine is right for everyone, no single company can supply sufficient vaccine doses for global needs and differences among the vaccines lead to different needs with respect to storage, shelf-life, distribution requirements, etc. Each vaccine needs to be evaluated to learn the level of protection from disease it provides – termed “absolute efficacy” — which is determined by comparing the vaccine to no vaccine (or placebo). Only with this sort of information in hand can regulators and healthcare providers assess which vaccines work best for which people and how they should be used.

How does the Novavax Trial fit into the current picture in the US?

The Novavax trial is a placebo-controlled trial, so enrollment will be focused on at-risk individuals who are not included in the “first waves” of distribution of EUA vaccines; that is, non-healthcare essential workers and older adults who do not live or work in long-term care facilities. We are committed to ensuring participation of people of color and adults with underlying high-risk conditions in the Novavax study.

To ensure that adequate follow-up of study volunteers can be achieved to characterize the absolute vaccine efficacy, study participants should be willing to not receive one of the EUA vaccines for up to 3-6 months. Based on the current situation with “roll-out” of EUA vaccines, that is not an unreasonable period for the general population to expect to wait for an EUA vaccine.

I am considering this study and not in a priority group for EUA vaccination. What does this trial mean for me?

Not being in a “priority group” does not mean you’re not “at risk” for COVID-19. In early 2021, the pandemic is spreading widely throughout the nation by community transmission, and many people who are not identified as “high risk” are nevertheless becoming ill.

It is not anticipated that EUA vaccine doses will be available for the broad population in the US for several months. Thus, you may still want to participate in this trial, in which you have a 2 out of 3 chance to receive active vaccine immediately.

What about when this vaccine shows protective efficacy or others are finally available?

Because vaccines have been able to demonstrate efficacy in only 2-3 months, Novavax has proposed to FDA a modification to this trial design to provide the alternate study injections to all study participants after efficacy has been confirmed. This would be accomplished in what is called a “blinded crossover,” meaning that study participants who initially received placebo would receive active study vaccine, and those who initially received active vaccine would receive placebo.

The advantage of this approach is that all study participants will receive active vaccine, either at the beginning or after a few months. Over the course of the subsequent months of follow-up, the trial will be better able to demonstrate how long protection lasts after initial vaccination. The duration of protection afforded by a vaccine is important information that is otherwise difficult to acquire.

If you decide to volunteer for this trial, you will be notified as soon as FDA agrees to this proposal and will be asked to provide your consent to participate in the modified trial.

Continued follow-up in the trial will also allow more detailed information to be learned about the safety and efficacy of the vaccine in specific groups of people and with respect to different clinical manifestations of COVID-19.

What if I want to leave the study after I join to obtain an EAU vaccine?

People on the study are free to leave at any time as their participation is purely voluntary. We ask that people who do choose to obtain an EUA vaccine continue to attend study appointments and share data on their health and any infection with COVID-19 for as long as possible, so that the study can complete as early as possible.

I am participating in this study and have the opportunity to receive an EUA vaccine. What should I consider before deciding to be unblinded and what does it mean for my study participation?

As a participant in this study, you had a 2 in 3 chance of receiving the active vaccine at the time of enrollment. There is therefore a good chance you have already received a product that may provide you with protection against COVID-19.

If the “blinded crossover” is approved by FDA, all study participants who initially received placebo will receive active vaccine after efficacy is confirmed. Therefore, staying in the study will allow you to continue to contribute to the important information that will help everyone know the best way to use this vaccine.

Nevertheless, being unblinded to decide if you want to get an EUA vaccine is up to you and doing so will not affect your medical care or follow-up in the study. Unblinding will remove you from the study population that will contribute to determining how well the vaccine works, which initially prompted your voluntary participation. Demonstrating the vaccine is effective and safe could become more difficult if people choose to unblind in favor of receiving an EUA vaccine.

 

Help keep Tabs on COVID-19 in the Greater Rochester Region

Help us keep tabs on COVID-19 in the Greater Rochester region. The better we track it, the faster we can all get back to our lives.

Click here to learn more. 

 

Future Covid-19 Vaccine Studies

In anticipation for the start of a coronavirus vaccine studies we will need the help of our community of volunteers. Currently we have available research studies for Covid-19, however, we are actively tracking a list of companies with plans to conduct additional vaccine studies this year.  Fill out the “Do You Qualify” question on the left, so a patient recruitment specialist can add you to an interest list for a coronavirus vaccine research study.   With your help, Rochester could be a part of the development of a potentially life saving vaccine.

Thank you for your continued dedication to advancing medicine and changing lives.