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Clinical trials (and tribulations): the immediate effects of COVID-19 on IBD clinical research activity in the United Kingdom.

ABSTRACT: There have been immediate and profound impacts of SARS-CoV-2 and COVID-19 on healthcare services worldwide with major consequences for non-COVID-19 related healthcare. Alongside efforts to reconfigure services and enable continued delivery of safe clinical care for patients with IBD, consideration must also be given to management of IBD research activity. In many centres there has been an effective shutdown of IBD clinical trial activity as research sites have switched focus to either COVID-19 related research or clinical care only. As a result, the early termination of trial programmes and loss of potentially effective therapeutic options for IBD, has become a real and worrying prospect. Moreover, in many countries research activity has become embedded into clinical care - with clinical trials often providing access to new therapies or strategies - which would otherwise not have been available in standard clinical pathways. This pandemic has significant implications for the design, conduct, analysis and reporting of clinical trials in IBD. In this Viewpoint, we share our experiences from a clinical and academic perspective in the United Kingdom, highlighting the early challenges encountered and consider implications for patients and staff at research sites, sponsors, research ethics committees, funders and regulators. We also offer potential solutions both for now and for when we enter a recovery phase from the pandemic.

SUBMITTER: Noor NM

PROVIDER: S-EPMC7337665 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Clinical Trials [and Tribulations]: The Immediate Effects of COVID-19 on IBD Clinical Research Activity in the UK.

Noor Nurulamin M NM Hart Ailsa L AL Irving Peter M PM Ghosh Subrata S Parkes Miles M Raine Tim T

Journal of Crohn's & colitis 20201201 12

There have been immediate and profound impacts of SARS-CoV-2 and COVID-19 on health care services worldwide, with major consequences for non COVID-19 related health care. Alongside efforts to reconfigure services and enable continued delivery of safe clinical care for patients with IBD, consideration must also be given to management of IBD research activity. In many centres there has been an effective shutdown of IBD clinical trial activity as research sites have switched focus to either COVID-1 ...[more]

PMID: 32598438

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Project description:Fibrolase is the fibrinolytic enzyme isolated from Agkistrodon contortrix contortrix (southern copperhead snake) venom. The enzyme was purified by a three-step HPLC procedure and was shown to be homogeneous by standard criteria including reverse phase HPLC, molecular sieve chromatography and SDS-PAGE. The purified enzyme is a zinc metalloproteinase containing one mole of zinc. It is composed of 203 amino acids with a blocked amino-terminus due to cyclization of the terminal Gln residue. Fibrolase shares a significant degree of homology with enzymes of the reprolysin sub-family of metalloproteinases including an active site homology of close to 100%; it is rapidly inhibited by chelating agents such as EDTA, and by alpha2-macroglobulin (?2?). The enzyme is a direct-acting thrombolytic agent and does not rely on plasminogen for clot dissolution. Fibrolase rapidly cleaves the A(?)-chain of fibrinogen and the B(?)-chain at a slower rate; it has no activity on the ?-chain. The enzyme exhibits the same specificity with fibrin, cleaving the ?-chain more rapidly than the ?-chain. Fibrolase was shown to have very effective thrombolytic activity in a reoccluding carotid arterial thrombosis model in the canine. A recombinant version of the enzyme was made in yeast by Amgen, Inc. (Thousand Oaks, CA, USA) and called alfimeprase. Alfimeprase is identical to fibrolase except for a two amino acid truncation at the amino-terminus and the insertion of a new amino-terminal amino acid in the truncated protein; these changes lead to a more stable enzyme for prolonged storage. Alfimeprase was taken into clinical trials by Nuvelo, Inc. (San Carlos, CA), which licensed the enzyme from Amgen. Alfimeprase was successful in Phase I and II clinical trials for peripheral arterial occlusion (PAO) and central venous access device (CVAD) occlusion. However, in Phase III trials alfimeprase did not meet the expected end points in either PAO or CVAD occlusion and in a Phaase II stroke trial, and Nuvelo dropped further development in 2008.

Dataset Information

Clinical trials (and tribulations): the immediate effects of COVID-19 on IBD clinical research activity in the United Kingdom.

Publications

Clinical Trials [and Tribulations]: The Immediate Effects of COVID-19 on IBD Clinical Research Activity in the UK.

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