Update on COVID-19

Richmond Pharmacology update on SARS-CoV-2 infection control and management of clinical trials

 

I have communicated our company strategies in my last letter dated 19th March. Since then, we have continued trialing our patients with minor disruptions overall and completed ongoing cohorts of healthy volunteers. However, because of the government-imposed lockdown which commenced on the 23rd March, we have not recruited new patients or healthy volunteers.

We are running a study sponsored by the Richmond Research Institute (NCT04404062).This clinical trial is designed to provide infection rate data at a local level, including disease outcomes and immunity over time. The study is open-ended and involves testing for virus RNA using PCR and immune response testing for antibodies IgG and IgM. We will gain insight into whether we are protecting our workforce adequately, monitor trial participants’ wellbeing, and the timely detection of infection flare-ups. Additionally, RRI is in the process of contributing to LEOSS project (https://leoss.net/).

We are collecting data from two cohorts: a well-controlled cohort consisting of our workforce of around 180 people and an open cohort of family and household members of our staff, trial participants, and those who apply to be screened. The staff cohort represents a random sample as there is no randomisation bias. The open cohort may be influenced by selection bias: individuals who suspect an infection are more likely put themselves forward for testing [1] and therefore the prevalence of infections may be overestimated.

To date, we have tested 165 (92%) of our staff members and found that nearly 15% of individuals were PCR-positive. This high incidence surprised us as we made considerable efforts to control the infection from February 2020. We imposed a strict entry control to the building evaluating symptom scores, body temperature, travel, and contact tracing. This may be explained by our location. We are in the borough of London (Southwark) which has seen the second highest local coronavirus case load in the UK. Access to our unit is located on a main road near three major train stations used by hundreds of thousands of passengers per day [2,3]. During normal times, social distancing is very difficult to achieve as pavements are narrow and shops are busy.

Although our office staff showed high rates of infection, none of our resident volunteers tested positive, which means that we succeeded in keeping our trial participants safe. The good news is that none of those infected died and the severity of disease ranged from rare hospitalisations to no symptoms at all. This is in line with what we have seen in general studies [4] but comparatively much better than rates seen in New York City [5].

For the last four weeks, we have recorded no new infections demonstrating how well social distancing and lockdowns are working. Now that restrictions are loosened, we will monitor our staff cohort against the open control group of visitors.

The measures to control infections in the clinic remain in force. We have added distancing of beds and workspaces, and comprehensive testing upon entrance to the building. All staff and visitors are always required to wear adequate masks when in the building and are given gloves and access to ample amounts of disinfectants.

Office staff who do not need to be present in the unit continue to work from home and those who are required at the unit are working in shift patterns minimising the opportunity for transmission of the virus if present.

Consequently, our capacities are reduced, and we are liaising with our sponsors to manage timelines. We are further optimising all processes to focus staff working times on essential tasks allowing as many studies as possible to progress. Trial participants will continue to travel to our site as normal, but we will ensure that risk from exposure during travel is minimised. We do not envisage to conduct home visits and will not replace safety relevant visits with virtual tools as these appear to pose an even higher risk to patients. The latter is well recognised [6] whereby patients are now far less likely to present to an emergency room with cardiac symptoms, leading to a much higher risk of non-COVID-19 related mortalities than before.

We look forward to restarting enrolment of patients and healthy volunteers to ongoing studies from the first week of June 2020. We plan to increase our capacity over time with regular impact assessments.

We thank our sponsors for their tremendous support and the team spirit displayed during challenging times.

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

References

  1. Ganguli, M., Lytle, M.E., Reynolds, M.D. and Dodge, H.H., 1998. Random versus volunteer selection for a community-based study. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, 53(1), pp.M39-M46.
  2. London Underground Performance Reports, available at: https://data.london.gov.uk/dataset/london-underground-performance-reports
  3. Train Station Usage, available at: https://data.london.gov.uk/dataset/train-station-usage
  4. CDC COVID Response Team, 2020. Severe outcomes among patients with coronavirus disease 2019 (COVID-19)—United States, February 12–March 16, 2020. MMWR Morb Mortal Wkly Rep, 69(12), pp.343-346.
  5. Richardson, S., Hirsch, J.S., Narasimhan, M., Crawford, J.M., McGinn, T., Davidson, K.W., Barnaby, D.P., Becker, L.B., Chelico, J.D., Cohen, S.L. and Cookingham, J., 2020. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City area. Jama.
  6. Garcia, S., Albaghdadi, M.S., Meraj, P.M., Schmidt, C., Garberich, R., Jaffer, F.A., Dixon, S., Rade, J.J., Tannenbaum, M., Chambers, J. and Huang, P.P., 2020. Reduction in ST-segment elevation cardiac catheterization laboratory activations in the United States during COVID-19 pandemic. Journal of the American College of Cardiology.

Click here to view the statement as a pdf document.

Testimonials

I am very pleased with the Project Management of both studies undertaken on behalf of (blank) and any future studies we have to outsource will automatically be contracted to you.

- Anonymous

Many thanks for your time today, most impressed with the quality of the follow up to our enquiry.

- Anonymous

Please know that it has been an absolute pleasure collaborating with you and that I am most appreciative of the key contributions RPL has made to this project thus far. I hope I have the opportunity to work with RPL again in the very near future.

- Anonymous

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