Updated on April 1, 2020
It’s hard to escape news about COVID-19. And with good reason. As an organisation on the front line of finding vaccines for diseases such as Coronavirus, our number one priority is the health and safety of our staff, our clinical trial participants, and the broader community.
We have answered some of the most frequently asked questions below. If you have any other questions, please get in touch with us at 651-641-2900.
Is there any impact from Coronavirus (COVID-19) on clinical trials at Nucleus Network sites (Centre for Clinical Studies, Q-Pharm or Prism)?
Nucleus Network is committed to continuing the vital work undertaken by our clinical trials, with studies continuing to take place.
While Coronavirus (COVID-19) infection rates in Melbourne, Brisbane and Minnesota remain low, the safety and quality of our trials and facilities is our number one priority. We have introduced strict measures to ensure the safety of all clinical trial participants, visitors and staff, and the quality of our trials.
In addition to the standard infection control practiced in its three clinics, Nucleus Network has implemented increased risk mitigations associated with Coronavirus (COVID-19). These include:
- Coronavirus (COVID-19) participant / patient screenings on phone and in-clinic,
- Regular hand sanitizing using alcohol-based hand rub with 70% alcohol,
- Every second bed practice to surpass ‘social distancing’ requirements,
- 6 feet spacing in waiting, dining and recreational areas,
- Personal Protective Equipment (PPE), are worn by medical officers, nursing and clinical staff during all participant interactions requiring close physical interaction.
- Isolation protocols are in place where additional PPE, including goggles, gowns and masks, are worn as appropriate when required for any person displaying high risk symptoms, this includes utilizing dedicated bed and bathroom bays
- Infection prevention and control procedures in line with World Health Organisation (WHO) and best practice guidelines.
These measures go above and beyond recommended clinical practices and provide a gold standard in infection control. We will continue to update and refine its approach to Coronavirus (COVID-19) as more information about the virus continues to be learned.
Can I still participate in a Nucleus Network clinical trial?
Yes. We are still recruiting for clinical trials however have implemented an age restriction on participants of 18-59 years (inclusive) to protect older members of our community. We are currently only allowing volunteers from the Minneapolis/St. Paul area.
The risk of Coronavirus (COVID-19) remains low for all our trial site locations (Melbourne, Brisbane and Minnesota), however, to protect the safety of our participants, staff and trial facilities, we have introduced some additional screening measures.
It is important that you self-isolate if you have knowingly contracted Coronavirus (COVID-19)
You must answer truthfully when providing information via our online, print and phone channels. Providing false information would equate to an offence.
Phone screening: Participants will be questioned over the phone to determine if they have any risk factors for Coronavirus (COVID-19) exposure.:
- Travel to or contact with someone who has travelled overseas or out of state within the last 14 days
- Have stayed or are currently residing in accommodation with high occupant turnover - This includes dormitory type accommodation within the last 14 days
- Had direct contact with anyone known to be infected with Coronavirus (COVID-19), and/or
- Currently have or have had cold / flu symptoms in the past 14 days.
Anyone who answers ‘yes’ to any of the questions above should not visit the unit. If you already have a screening appointment planned, please call 651-641-2900
Medical screening (in clinic): The above questions will again be asked when the participant presents for their screening visit and the participant will also have their temperature taken and be requested to wash their hands with hand sanitiser upon presentation. However, we ask that if participants do have any cold or flu like symptoms, they inform the clinic and do not attend their medical screening. We will advise the most appropriate action.
Outpatient visits (in clinic): Active trial participants attending the site for an inpatient or outpatient visit will be required to undergo the same process as described above. It is important for participant safety that all outpatient visits are attended as scheduled during the trial process. However, we ask that if participants do have any cold or flu like symptoms, they inform the clinic and not attend their medical screening. We will advise the most appropriate action.
Are clinical trials included under the ‘essential travel’ classification?
Yes. Clinical trials play an imperative, and essential, role in advancing medicines (including vaccines) for the entire community and therefore meet the essential travel requirements.
Have social distancing measures been implemented at Nucleus Network sites (Centre for Clinical Studies, Q-Pharm or Prism)?
Yes. Nucleus Network is strictly to social distancing measures with all Nucleus Network sites meeting the 6 ft per person distancing requirements. To ensure we meet, and surpass, this distance we have implemented an ‘every second bed’ policy, where the clinical beds are a minimum 6 feet apart.
What if I feel unwell after being admitted for a confinement period for a clinical trial?
Trial participants who begin to experience side effects, changes in their health or have concerns should always speak with the clinical staff / study doctor as soon as possible. In relation to Coronavirus (COVID-19), any fever, cough or other flu like symptoms noted should immediately be brought to the attention of clinical staff. We will need to medically assess participants and, if necessary, relocate to a different area for further treatment whilst it is established what the cause is.
Can I still have visitors during my stay at the facility?
Visitors are usually permitted during long-stay trial admissions. However, to reduce risk of Coronavirus (COVID-19) transmission we will be restricting visitor access at our facilities until further notice. We apologise for this inconvenience and understand the stress this may cause in some cases. We will work with trial participants to find alternative ways to remain in contact with family and friends.
With your help, we can make a difference in the containment of COVID-19 as together we work on developing the medicines of tomorrow.