Statement: COVID-19

Posted:
23
March 2020

Richmond Pharmacology are continuously risk-assessing our activity in relation to the COVID-19 crisis and we are evaluating what activity can continue, what precautions need to be put in place and what needs to be suspended.

Richmond Pharmacology are continuously risk-assessing our activity in relation to the COVID-19 crisis and we are evaluating what activity can continue, what precautions need to be put in place and what needs to be suspended. We are currently operating as close to normal as possible and are planning to continue managing our clinical trials and caring for all our trial participants throughout this period.

From today, many research centres and all NHS clinical trials units have stopped enrolling trial participants. However, according to advice issued by the MHRA, trials can continue based on up-to-date risk assessments. Guidance on how trials can be managed throughout the crisis have been issued by FDA and EMA and you will be aware of that. We have, however, paused trials where immunity may be affected and also delayed some of the healthy volunteer trials in agreement with our sponsors in order to free up spare beds and staff. This reduction in workload provides us with the resource and capacity to deal with the unforeseen and unplannable events already occurring daily, a situation that will undoubtedly worsen. Efficiency and careful planning has always been important to Richmond, in the current climate it is a necessity.

Over the last eight weeks we have introduced a series of containment measures, such as tracking travel history and body temperature reading for everyone entering our facilities. Anyone with a travel history to endemic areas and or an elevated body temperature was refused entry to the site. Finally, this week we have conducted an IgM and IgG antibody test to gauge the rate of undetected infections in our workforce and volunteers currently housed in our clinic. To date we have not identified anyone with current or past infections, i.e. anyone who has already developed an immune response to the virus.

Unfortunately, this IgM and IgG antibody test does not account for anyone infected pending immune response and/or symptoms; both incubation and immune response have a considerable time lag. We are now in the process of taking samples for a PCR test to detect the virus itself. In the first instance the purpose is to identify all those who are Sars-Cov2 infected but have not developed symptoms of COVID-19 yet. This initial testing round will run for a few more days. We are very glad therefore, that we are finally able to introduce more effective measures of infection control. Most experts agree that widespread testing is essential for the effective management of the disease spread and we are proud to have initiated on a small scale what should have happened on a country-wide scale much earlier on.

We will continue periodic testing in the future to remain up to date regarding infection status. Anyone testing positive (patients and staff) will be asked to self-isolate and we will monitor their well-being using a daily SMS messaging system. Patients who are resident and cannot be sent home, will be isolated within our facility. More severe cases will be treated in accordance with current guidance and or referred as well as reported to PHE (COVID-19 is a notifiable disease). We have extensive policies in place and will continue to update these as the situation develops.

Given our collective lack of immunity, we will continue to rely on containment methods. We obviously need most of our staff members to be present in the office and we have limited ability to offer working from home. We have therefore introduced shift patterns separated by a cleaning break to reduce parallel desk usage (<40%) a measure designed to provide a two metre plus radius around anyone required working in the office. Wearing face masks is compulsory and we supply staff members with mask for travel to and from work. We have issued personal protection advice at home and at work to aid our staff and trial participants to stay infection clear for as long as possible. As we are now heading for the eye of the storm, with community infections growing exponentially, we will continue to tighten rules to make sure everyone remains safe and infection cases are managed accordingly. We are currently developing plans to deal with a substantial future rise in infections. We currently do not anticipate travel restrictions affecting our operations beyond having to cease screening new participants for healthy volunteer trials when mandated to do so.

We have received Ethics Committee approval for a screening study which will commence today. This involves consent to the collection of data beyond the mandatory screening of staff, visitors and trial participants. This will provide useful longitudinal testing, show the effects of containment measures and will educate us in the development of immunity. The results will be shared through a peer-reviewed publication as soon as possible. This work is sponsored by the Richmond Research Institute.

We are assessing the situation daily and have assigned responsibilities within our team of directors to ensure that no interruptions to the supply chain will occur and to ensure contingencies are in place. We are actively inviting our sponsors to provide us with guidance on acceptable pre-planned optional protocol deviations so that data loss resulting from patients not being able to attend their study visits, due to COVID-19, can be controlled in a systematic way rather than introducing random error. This is particularly important for multi-centre trials. We are happy to participate in remote joint investigator meetings to agree strategies and encourage our sponsors to initiate those.

We are focussed on managing our affairs and will provide automatic updates to all stakeholders when appropriate. Rest assured that no news from us is good news! If you have any questions, please reach out. Bear with us if our response times are not what they normally are, and please phone us on matters of urgency.

Yours faithfully.
Dr Jorg Taubel MD FFPM FESC
Chief Executive Officer
Richmond Pharmacology Limited
1A Newcomen Street
London Bridge
London SE1 1YR

Click here to view the statement as a pdf document.

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