Resuming laboratory testing with human participants

On 27 May 2020 Mike Tipton chaired a session of over 650 physiologists from over 30 countries about the steps laboratories could take to minimise the risk of transmission of COVID-19 in trials involving humans to both staff and participants.

Disclaimer: Please note that all researchers must follow the advice and guidance issued by their national and local governments as well as their own institutions. The information presented on this webpage is intended to support your research and encourage discussion, it is in no way intended to be interpreted as specific guidance. This is a fast evolving situation and points raised at the time of publication (2 June 2020) may quickly become superseded by new information. The situation differs in countries across the world. The Physiological Society nor any of the contributors bear responsibility for the accuracy of this information. It is each researcher’s responsibility to ensure they comply with all legal and safety obligations.

Download the webinar slides

Re-watch the webinar 

Download the webinar chat transcript

Contributors: Prof Mike Tipton (Chair), Prof Carolyn Greig, Prof Ben Levine, Mr Geoff Long, Prof Igor Mekjavic, Prof Hugh Montgomery, Dr Paddy Morgan, Dr Dan Roiz de Sa, Dr Matt Wilkes, Prof Jennie Wilson

This document supplements the paper “Returning to the lab for human testing” published on the Physiological Society website. https://www.physoc.org/covid19/returning-to-the-lab/

It is supported by the three sets of materials linked to above.

This document was produced from the recording of the webinar which took place on the 27th May 2020. It has subsequently been reviewed by the contributors listed above. In what is a very dynamic situation, the comments and conclusions presented here have evolved even since the webinar on the 27th May and are themselves likely to have a limited lifespan.

Comments and Conclusions

1. Ethical considerations

  • Does the benefit of the proposed research outweigh the associated risks of Covid-19 (infection, critical resource [e.g. PPE] use) in society?
  • Stratify the risk related to the testing in terms of the tests to be undertaken, populations to be tested and those involved in the testing g.: Co-morbidities, age, geographical location (local infection rate) etc. of researchers and participants. But, easiest to treat everyone as potentially infected and mitigate the associated risk by taking “universal precautions”.
  • Risk of consequences of infection is variable depending on the group under consideration:
    • Individuals with diabetes, known cardiovascular disease, and older individuals, over the age of 65, especially if they have chronic medical conditions or are frail appear to be at especially high risk of adverse consequences of Covid-19 infection. They should be considered the highest risk within a risk/benefit ratio of participation in research activities.
    • Middle aged health adults – probably at lower risk of complications from Covid-19, although it should be recognized that lack of co-morbid conditions does not provide complete protection from adverse outcome of Covid-19 infection.
    • Children and youths: risk of dying may be lower than other groups. However recent data show that even younger individuals may develop a severe cardiovascular inflammatory condition as a consequence of Covid-19.
    • Therefore, although the risk/benefit ratio of participating in research likely varies with regard to age and co-morbid conditions, the risk is present in all groups, and careful consideration of this ratio in specific research groups, along with universal precautions must be undertaken for all potential participants.

2. Medico-legal & insurance considerations

  • Consider the protection of staff who may have underlying chronic health problems (e.g. diabetes, cardiovascular diseases, renal or respiratory problems), or a disability that may put them at increased risk i.e. staff risk stratification. Seek own institution’s Occupational Health Department advice where there is doubt or concern.
  • Establish the position regarding the specific cover offered by your institutional insurance/compensation schemes for researchers and participants. Insurance cover is likely to be tightly linked to government policy and what it permits/requires at the time.
  • Treat everyone as potentially infected.

3. Recruitment and health assessment

  • Employ preliminaries (recruitment, initial consenting, health history, questionnaires) moved securely online.
  • For numerous reasons, at this time, it is reasonable to base the assessment of a participant in terms of Covid-19 on symptom-based screening, and recent exposure history rather than depending exclusively on PCR viral RNA testing. However, this is not a unanimous view, and is a quickly evolving area. The most common symptoms of coronavirus can be seen on slide 9 of the slide deck provided.
  • It is simpler to regard anyone with symptoms as potentially coronavirus positive and exclude them from the study until their symptoms disappear completely.

4. Laboratory practice

  • Be guided by relevant government guidance
  • Set up lab as recommended in https://www.physoc.org/covid19/returning-to-the-lab/ and on webinar slide deck.
  • Wash hands/use alcohol gel on entering and leaving the lab and frequently in between. Stay 2 m apart, this applies primarily to face to face orientation, a mouth covering reduces the spread of droplets (see Note 1 at end of document).
  • High intensity exercise and associated increased ventilation increases the distribution of any virus (possibly by aerosolized as well as droplet particles) and thereby increases the risk of infection, especially if the high rates of ventilation persist for more than 5 minutes.  This risk is highest in front of the participant (or near the expiratory valve, especially if filters are not used). Spirometry and maximum exercise testing are possibly aerosol generating procedures and increase the risk of spread beyond the typical 2 m of social distancing during quiet rest (see Note 1 and supplementary material). This type of activity generates droplets, and it is therefore important to decontaminate and disinfect the kit used (mouthpieces etc.) and the surrounding area (see below).
  • The risk to research staff associated with these tests can be mitigated by wearing appropriate eye protection and mask, remaining at least 2 m away from the participant during exercise testing, and by disinfection of kit etc. between tests (see below).
  • The risk of any single procedure with a participant can be viewed like exposure to radiation: 1) the procedure itself; 2) the distance from the source; and 3) the duration of exposure
  • Open spaces are associated with a reduced risk of infection, however the same recommendations (distancing, PPE, disinfection) apply.
  • The question “when can we go back into the lab to undertake human testing” is not best answered with a date or time, it is best answered by saying that this can occur when it is permissible to go back to work (Government/Institutional decision) and, in the likely absence of specific advice for those undertaking physiological testing with humans, when researchers have appropriate procedures and mitigations in place (as described in this document and the associated information provided). There is no reason why the second of these requirements cannot be instigated at this time.

5. Disinfection and filtering

  • Repeated and rigorous handwashing and/or use of alcohol gel should be enforced. Soap is highly effective. Hands that are sterile can pick up virus from work surface, the mouth and can immediately be spread – so clean hands at every opportunity. Surfaces that may have been contaminated by respiratory droplets e.g. during exercise tests should also be cleaned with detergent and water/disinfectant wipes.
  • Wipe down all surfaces with viricidal solutions/alcohol wipes when used (g. handles on kit, keyboards) and fully clean all surfaces at the end of each testing session and day.
  • Disinfection – shared equipment needs to be cleaned/disinfected rather than sterilised.  There are a lot of detergent/chlorine cleaning wipes on the market that are good for this. It is worth washing mouthpieces with detergent before disinfecting with an appropriate solution.
  • Treat anything worn in the laboratory as “infected” and dispose of it carefully before washing hands. Likewise, protective face screens should be cleaned (alcohol wipes or soap and water) on removal.
  • Thermal factors only really relate to the longevity of the virus. Raising the temperature kills the virus: at 22 °C Covid-19 lasts 72 hours on plastic, 48 hours on steel, 24 hours on cardboard (closest test to clothing), 4 hours on copper. Virus survival increases (3 log-fold) with falling temperature. Best to elevate cold rooms between tests to sterilise.
  • Environmental chambers should be heated (as close to 56 °C for 45 min as possible) and/or properly ventilated between tests.
  • Worries about air conditioning (and/or ducts circulating air in environmental chambers) spreading Covid-9 are overstated. The virus is primarily spread by droplets and these will not distribute through air conditioning. Aerosol generating procedures may cause the virus to remain airborne for longer (see Note 1). The simple expedient of opening a lab window will dilute and help disperse any aerosols safely (dispersed within an hour in a normally ventilated room). If in an enclosed chamber environment, one complete air change with fresh air will reduce airborne contaminants by 63 %, and 5 complete air changes will reduce this to lower than 1 %.

6. PPE

  • There is a training requirement for the correct use and fit of PPE. Training videos are available from reputable suppliers/manufacturers of such equipment.
  • If there is a requirement for FFP3 mask protection this must be properly fitted. In the UK this is a requirement under HSE guidance. https://www.hse.gov.uk/news/face-mask-ppe-rpe-coronavirus.htm
  • PPE should be used to protect both researchers and participants.
  • Standard infection control precautions (SICP) – gloves and aprons – single use/task.
  • Fluid-resistant (Type IIR) surgical masks (FRSM) and eye protection or respirator/FFP3 can be used throughout a single testing session but should be discarded when removed and not re-used.
  • If a disposable fluid repellent coverall and long-sleeved disposable fluid-repellent gowns is required, it can also be used for a testing session, but should be covered with an apron if moving between participants and changed between each person.

Wearing goggles stops passing the virus from work surface to hand and eye, and a mask into the mouth. It also limits spread through coughing.

  • Although widely advocated, gloves are unnecessary and may be counterproductive (see Note 2). Better to rely on strict hand decontamination pre, during and immediately post handling participants. Gloves should be used if taking blood or handling any body fluids or equipment contaminated with body fluids. Gloves should be changed after each participant contact before touching other equipment such as keyboards
  • Recommended PPE for different scenarios: https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control/covid-19-personal-protective-equipment-ppe
  • Basic PPE requirement for physiological research & teaching: goggles, surgical mask. Add gloves for blood and body fluid contact, or touching contaminated equipment and PPE.
  • Face protectors/screens that cover round the face and below the chin may be more practical than a mask (which is uncomfortable and tends to get touched a lot – increasing the risk of transferring virus to the hands).
  • Face protectors can be re-usable – need to be wiped clean with detergent/disinfectant at the end of each session.
  • Not overly worried about clothing worn beneath PPE – can be cleaned at the end of the day (60 °C wash) or disinfected (shoes). Sensible to have a set of “work clothes”. Don’t over pack the washing machine.

7. Experimental design

  • The processes necessitated by the mitigation of the risk of Covid-19 may mean that alternative approaches to addressing questions become more feasible. This may include alterations in experimental design, analytical techniques, wash-out periods and other logistics such as minimizing staff in the room at any one time, and reducing trainees or other observers.

Links

GENERAL
PPE & COVID-19
RESUSCITATION GUIDLINES
INFECTION PROTECTION & CONTROL: Health-care setting
DISINFECTION
CLEANING & WASTE: Non-healthcare settings

Notes

Note 1. Respiratory. There are two types of risk:  a) droplets – these larger particles are generated through coughing, sneezing and speaking and transmit infection by landing on mucosal surfaces or indirectly by contaminating nearby surfaces and subsequently hands (but are most generated close to person – 2 m).  The face mask (and eye protection) protects the mucosa and therefore transmission – it works both ways by reducing the amount of particles eliminated from a person with infection and protecting the mucous membranes from contamination.  Social distancing is intended to minimise the risk of exposure in this way and if in closer proximity that 2 m a surgical mask can be used to protect the mucosa   b) respiratory aerosolised particles – these are very small, remain airborne for longer and may travel over longer distances. However, they are most markedly generated in large (and therefore risky) quantity when specific procedures on the respiratory tract are undertaken e.g. Intubation, tracheostomy, bronchoscopy, airway suctioning.  These are called Aerosol Generating Procedures (they have been defined by PHE) and for those involved in undertaking them a higher level of protection is recommended – in particular the high filtration respirator (FFP3) rather than a surgical mask.

Note 2. Gloves are only indicated for direct contact with blood and body fluids as these are likely to contain high concentrations of pathogens but must be removed and hands washed immediately after the procedure.  Other contact with patients will result in picking up microorganisms on the hands but these are in small in number and easily removed by alcohol gel or soap and water.  The fact that gloves are routinely worn for all types of contact with patents is not because they are required, and certainly not part of infection control policy – it has become a practice adopted by large numbers of staff for no good reason other than habit and it’s what everyone else does!

Recommendations to wear gloves/aprons for all direct contact with known Covid-19 patients (known as contact precautions) have been made (by PHE, WHO) presumably with the aim of reducing the amount of contamination from virus on surrounding surface on the hands (the virus will not pass through skin so there is no reason to wear gloves to protect the skin).  However, the use of gloves in this way is not logical because the virus is easily removed by hand hygiene and unless the gloves are changed between procedures then the virus and other pathogens will be transferred between surfaces on gloves – increasing the risk of spread.

(Professor Jennie Wilson, Richard Wells Research Centre, University of West London).

Authors & contributors

Mike Tipton (Chair)
Professor of Human & Applied Physiology, University of Portsmouth, UK.

Carolyn Greig
Professor of Musculoskeletal Ageing and Health, University of Birmingham, UK.

Benjamin Levine
Director, Institute for Exercise and Environmental Medicine, S. Finley Ewing Jr. Chair for Wellness at Texas Health Presbyterian Dallas, Harry S. Moss Heart Chair for Cardiovascular Research, USA
Professor of Medicine and Cardiology, Distinguished Professorship in Exercise Science, The University of Texas Southwestern Medical Center, USA

Geoff Long
Principal Technician, University of Portsmouth, UK.

Igor Mekjavic
Professor of Environmental Physiology and Scientific Counsellor, Jozef Stefan Institute, Slovenia.
Adjunct Professor, Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, British Columbia, Canada,

Hugh Montgomery
Professor and Consultant Intensivist & Director for Research and Innovation, Whittington Hospital
Head, Centre for Human Health and Performance, UCL Division of Medicine
Research team lead, Institute for Sport, Exercise and Health, 170 Tottenham Court Road, London W1T 7HA.

Paddy Morgan
Anaesthetist, North Bristol NHS Trust, UK.
Great Western Air Ambulance, Bristol, UK.

Dan Roiz de Sa
Senior Medical Officer, Environmental Medicine & Sciences, Institute of Naval Medicine, UK.

Matt Wilkes
Independent Medical Officer, SSHES, University of Portsmouth
Fellow in Critical Care Medicine, Royal Infirmary of Edinburgh

Jennie Wilson
Professor of Healthcare epidemiology, Richard Wells Research Centre, University of West London, UK

Acknowledgements: Andrew Mackenzie, Thomas Addison and Liam McKay of The Physiological Society

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