REACT COVID-19 Study
Article Review: Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
At the time of this paper’s submission, 66,000 people had lost their lives to SARS-COV-2. That number has since increased to over 121,000 In the UK and 2.48 million worldwide.*
With roll-out of a number of licenced vaccines, in the eyes of many, the fight is believed to be won. But that may not be the case.
The Pfizer vaccine is reported to be effective to around 95%, the industry is yet to distribute a vaccine which claims to be 100% effective in every case. In order to design effective and efficacious vaccines and ensure public safety, more understanding of the natural history of SARS-COV- 2 is required.
On the 22nd Jan 2021 this paper published by Burke et al, outlines a longitudinal Research Evaluation Alongside Clinical Treatment for COVID-19 study (REACT COVID-19) whereby patients were expertly observed alongside their treatments to develop an understanding of SARS-COV-2 infection and pathology.
Study design and outcomes
The REACT platform is a near real-time, digital record used to access trial data and provide investigators with integrated visualisations to aid more timely and effective decision making. https://digitalecmt.org/about-us/react/ The platform was originally designed for use in assessing the benefit of early-phase cancer therapeutics.
Here, the platform was adapted to link electronic and manual patient records taken at site to the REACT platform. Data collection began in March 2020 and patient recruitment commenced at the point of testing positive for SARS-COV2. With no restriction on recruitment, trial data quickly amassed. By uploading the data into the platform, natural history of the disease could be rapidly captured and aligned to monitor disease trajectories.
The study consisted of two parts. The first being- collection of core data. Upon recruitment, patient-identifiable data collection included demographics, admission symptoms, co-morbidities and risk factors. Identification of disease severity determined the subsequent monitoring methods of data collection.
SARS-COV-2 positive patients who did not require hospital admission were able to submit their data via an online survey via My Medical Record. Those at level 1 disease severity had their data entered through CHARTS, an integrated user interface for electronic health care records. The data collected consists of clinical observations, laboratory test results (full blood count/ C reactive protein count) and pathogen testing via nasopharyngeal swab, among other information.
Data collection for patients at disease severity level 2/3 was collected using METAVISION, a clinical information system for critical care. Recording of medication changes, observations including fluid balance, ventilation methods, radiology, renal replacement therapy and more, was included here.
This data could be extracted from electronic records and entered into BC INSIGHT. At The point of entry into BC INSIGHT, the data is encrypted and anonymised. This initiates the second section of the trial. From BC INSIGHT, the data is uploaded onto the REACT platform and any other relevant data could be entered manually by clinical researchers. Patients were tracked in this way for 12 months to gather data on SARS-COV-2 disease history.
The purpose of biobanking is to process and store biological material for use in research and clinical care.
A sub-cohort of patients were able to provide biological samples including blood, urine, sputum, nasal samples, exhaled breath and bronchial wash samples at any point during their care in hospital. Storage of patient biological samples in this manner allows for future studies and analysis, aimed at uncovering biomarkers of COVID-19 and potential assembly of a disease timeline.
A historical example of disease-centric biobanking success was the University of California, San Francisco (UCSF) biobank, established in California 1982 during the AIDS epidemic. At that point, little was known about the exact causative mechanisms of AIDS, however, collection and effective biobanking of biological samples from AIDS patients enabled investigators to rapidly develop a detailed understanding of the disease. Even now, decades later, the biobank is a significant research tool used to study AIDS. https://academic.oup.com/labmed/article-abstract/22/11/790/2658500?redirectedFrom=fulltext
Similar logic is being applied here, to the current COVID pandemic and will become a valuable tool in dissecting SARS-COV-2 pathological mechanisms as we begin to understand the natural history of this disease.
Strengths and limitations
This study transforms data collection and study monitoring through use of an electronic, near real-time platform allowing investigators to access up to date trial data with variable scope- from individual patient data to trends in mass trial data. The REACT platform is also able to amalgamate a variety of data types, including aligning phenotypic observational data to genomic, transcriptomic and proteomic data. This multi-disciplinary approach allows rapid and effective decision-making progression on a patient-by-patient basis whilst understanding disease trajectory and accounting for trends in cohort data.
A significant blind-spot in current understanding of SARS-COV-2 infection surrounds the lack of data regarding impacts of specific co-morbidities in response to infection and potential treatment options. The heterogenous presentation of this disease demonstrated the need for identification of relevant co-morbidities and risk factors in disease severity. Even in patients with similar risk profiles, current observations have shown varying severity of disease progression.
This similarly allows investigators to identify individual patients which were eligible to be approached for intervention studies, as well as predicting patterns of disease trajectory and anticipate treatment options.
The study has excellent potential to make significant contributions to the current field of SARS-COV-2 research, through improved implementation of innovative data collection platforms, integrated with the use of biobanking to provide insights into disease pathology.
The current study is limited to only a single centre, but could be readily implemented into a number of sites to validate its efficiency.
Though the REACT software shows promise to improve data collection strategies. Biobanking studies are limited by the integrity of the samples, processing, handling and logistics. Cryoniss’ quality philosophy mirrors the ingenuity shown by the REACT study. With our tailored service, we securely store research and clinical samples with real time monitoring whilst being agile and responsive to ensure the safety and integrity of every sample during biobanking studies.
*data correct as of 24/02/21