ISARIC Clinical Characterisation Protocol UK (CCP-UK) - a companion study for patients with Cancer and COVID-19 (CCP-CANCER-UK)

2019 a new virus called SARS-CoV-2 emerged, which causes a disease termed COVID-19. This is often mild but can also be severe, leading to viral pneumonia; about one in 100 infected people are expected to die of i t. However, cancer patients are likely to be at higher risk of infection and death as they have a weakened immune system as a result of either their treatment or their cancer. We will tackle many urgent questions that need answering in cancer patients to help ensure early diagnosis, that the correct shielding advice i s given, and to enable doctors and patients to make informed decisions regarding treatment during the pandemic. This will be achieved by collecting detailed data from the over 5,000 cancer patients recruited into the main UK study which has described COVID-19 (CCP-UK study). The cancer data when linked with the rich COVID-19 data will enable the following important questions to be answered:

What proportion of cancer patients die from COVID-19? How does this vary based on cancer type and cancer treatment?

What are the symptoms cancer patients develop with COVID-19? Does this vary based on type of cancer and treatment?

What type of cancer treatments puts people at higher risk of severe illness and death?

What kind of healthcare resources are needed (including intensive care) to treat COVID-19 in cancer patients?

How do the outcome of patients with cancer compare with non-cancer patients taking into account age and other illnesses?

Many people with treatable cancers have had treatment delayed or stopped by COVID-19 with potentially life-threatening consequences. Crucial information to guide decision making whether to continue or stop treatment is lacking.
As of 27th June 2020 5,395 of 66,574 patients i n CCP-UK have a history of cancer, recorded as Yes/No, on the CRF. No other cancer specific data were collected. We will enrich the CCP-UK data set by collecting detailed cancer data including tumour type, stage, time from diagnosis, and treatment given.

These data will answer the following questions:
(1) Outcomes: What i s the survival rate in cancer patients with COVID-19, how does this vary by cancer type, and with timing and potency of immunosuppressive treatment?
(2) How do outcomes compare with non-cancer patients after controlling for key confounders?
(3) Host: Does COVID-19 present differently in immunosuppressed cancer patients, or in different cancer types? Can clinical severity prediction be used to improve clinical management?
(4) Disease: What is the impact of the type and stage of cancer on COVID-19 outcomes?
(5) Cancer Therapy: What is the impact of chemotherapy, immunotherapy and other types of cancer treatment on risk of infection, severity and outcome?

Cancer patients may be more vulnerable to severe COVID-19 making development of a robust evidence base vital. Using the largest prospectively collected COVID-19 dataset of cancer patients will provide a rapid and efficient way to gain clinical evidence that is impactful, relevant and can directly inform practice for the benefit of cancer patients.