PACE
Research type
Research Study
Full title
The impact of COVID-19 on patients with AML undergoing chemotherapy: an epidemiological study.
IRAS ID
282870
Contact name
Simon Standworth
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
The pandemic of COVID-19 has had significant implications globally. It is known that patients with underlying health conditions are more likely to develop severe COVID-19 but many patients, including patients with Acute Myeloid Leukaemia (AML), cannot wait for treatment for their disease. Unfortunately both AML and the standard intensive or non-intensive chemotherapy options make these patients more likely to pick up infections. This observational study will recruit 100 patients with AML who are receiving, or due to receive, treatment with chemotherapy. The main aims of this study are to record how many of these patients have had COVID-19 previously, have an active infection or go on to develop COVID-19 whilst receiving treatment for their AML. Other serious infections patients may experience will also be recorded. We will collect information on the treatments patients received and their outcome. Patients will be seen according to standard of care, there are no trial specific visits or assessments. The information collected will all be provided from the patient notes. Patients will be recruited over 6 months from selected NHS hospitals across the UK by their AML doctor or nurse. Data will be collected for 24 months from study entry and all patients will be followed up for survival until the end of the study. An optional sampling sub-study will collect samples from patient's consenting to the substudy, to analyse the immune response to infection, viral shedding, and the affect of the microbiome on Covid-19 infection.
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0059
Date of REC Opinion
1 May 2020
REC opinion
Favourable Opinion