It was not true that no-one was preparing for a novel coronavirus pandemic. The ISARIC Investigators did just that when they co-developed the Clinical Characterisation Protocol with the WHO in 2012 as Middle East Respiratory Syndrome Coronavirus emerged as a public health threat. The value of the protocol for describing novel disease was realised in an outbreak of MERS in the Kingdom of Saudi Arabia and the case report form was used in West Africa in 2014. In the UK the ISARIC protocol was been used to characterise sporadic cases of MERS and Monkeypox in 2012 and 2018, but mostly sat on shelves in a hibernating state. It was activated across the UK on 17th January 2020 in recognition of the pandemic potential of SARS-CoV-2.
The study has collated clinical data from 303,251 people age from birth to 106 years old in 306 hospitals, including acute and long term care facilities across the whole of the NS estate. This COVID Clinical Information Network (CO-CIN) provided near real time data in a continuous feed to the UK Government Scientific Advisory Group for Emergencies (SAGE), the New Emerging Respiratory Threats Advisory Group (NERVTAG) and the Scientific Pandemic Influenza Modelling Group (SPI-M).
The dynamic CO-CIN reports highlighted clinical evidence about coronavirus infection and disease for two years of the pandemic. At least 80 dynamic reports were tabled. 37 specific analysis were commissioned that relied upon this data for policy use, such as informing vaccination prioritisation, identifying hotspots of hospital acquired COVID, and optimising uptake of novel therapeutics.
Clinical material collected from 2914 participants provided insights for the mechanism of severe covid-19, material for International Standards, seed virus for human challenge studies and validation of the immunogenicity of the Oxford ChAdOx vaccine.
The UK HSA is key partner in the ISARIC collaboration and has a lawful data sharing framework with the study investigators. Many UK HSA colleagues are protocol authors. Having considered past and future threats, the protocol reach has recently been extended to enable enrolment of people exposed to pathogens, chemicals, toxins or potentially harmful energy sources of public health interest.
Dr Calum Semple is Professor of Outbreak Medicine and Child Health at The Univesity of Liverpool. He has studied severe virus disease outbreaks since 1989 in the fields of diagnostics, clinical characterisation and clinical trials. He was a founder member of ISARIC the International Severe Acute Respiratory and emerging Infection Consortium. He has led studies of COVID-19, MERS, Monkeypox, Ebola (EVD and Survivors), Influenza and Bronchiolitis, at times field-deployed in austere circumstances. He has recently been working closely with colleagues in UK HSA investigating the aetiology of Children with Acute Severe Hepatitis of Unknown Origin. He affiliates with the NIHR Health Protection Research Unit in Emerging and Zoonotic diseases, a joint venture between the Universities of Liverpool, Oxford and UKHSA.
In 2014 the WHO asked him to lead a research mission to Sierra Leone in the escalating phase of the Ebola outbreak. He led a consortium of investigators from University of Sierra Leone, the Connaught Hospital and Republic of Sierra Leone Armed Forces Joint Medical Unit along with international partners. Together they ran the first clinical trial in Sierra Leone since the civil war ended in 2002. In 2016 he and his team were awarded the Queen's Ebola Medal for Service in West Africa 2014-16 and in 2019 he received a Commonwealth Association Award for subsequent work with Ebola survivors in Sierra Leone.
He was a Senior Government Clinical Advisor siting on the Scientific Advisory Group for Emergencies (SAGE) for the COVID-19 response and the New Emerging Respiratory Viral Treats Advisory Group (NERVTAG), and a former member of the WHO Scientific Technical Advisory Committee for Ebola Emergencies (STAC-EE). He was appointed Officer of the Most Excellent Order of the British Empire in the Queen's Birthday honours 2020 for his role in the COVID-19 response.
He maintains a clinical role at Alder Hey Children's Hospital