A look inside the Coverage clinical trial by pharmacy extern Julie Perrot
Pharmacy Product Manager
As a pharmacy extern, I have been fortunate enough to work on the COVERAGE clinical trial promoted by Bordeaux University Hospitals and led by principal investigator Professor Denis Malvy, infectious disease expert and head of the tropical diseases unit at Bordeaux University Hospital, member of the IDLIC research team for “Infectious diseases in countries with limited resources” led by Doctor Xavier Anglaret at the Bordeaux Population Health Research Centre (Inserm and Bordeaux University).
What is COVERAGE?
While clinical trials are typically conducted inside the four walls of a hospital, the COVERAGE study has the unique characteristic of taking place directly in patients’ homes in the form of an ambulatory clinical trial. This means that mobile teams made up of doctors, nurses, and medical interns travel around to include patients who have tested positive for COVID-19. Not all COVID-positive patients can participate, as one of the inclusion criteria is being over 60 years of age. In addition, participants must not present any criteria for exclusion, such as a hypersensitivity to any of the drugs in the trial. The goal of the COVERAGE trial is to evaluate the efficacy and safety of several experimental treatments to reduce the risk of hospitalisation or death related to SARS-CoV-2.
The drugs in COVERAGE
Following randomisation, patients are given one of the three following drugs or a dietary supplement for ten days. This being an adaptive trial, a fourth drug, hydroxychloroquine, had initially been proposed but was withdrawn due to its risk-benefit ratio being re-evaluated as potentially unfavourable.
Avigan ® (Favipiravir): An antiviral drug that selectively inhibits virus RNA polymerase. It has been proposed in Chinese recommendations as an alternative treatment option for patients infected with COVID-19 who are intolerant to other antiviral agents.
Imatinib TEVA ® : is an Abl2 (targeted Abelson tyrosine kinase inhibitor), which has shown strong action on SARS-CoV in the in vitro setting and has been identified in a database of potentially active drugs for highly pathogenic coronaviruses. Its antiviral activity occurs in the initial stages of the infection, following endosomal internalisation and trafficking, by inhibiting the fusion of virions with the endosomal membrane. Short-term treatment with Imatinib could be effective and well-tolerated in patients infected with SARS-CoV2.
Micardis ® (Telmisartan): SARS-CoV2’s cellular doorway is a membrane enzyme of the respiratory tract’s epithelial cells, known as the angiotensin-converting enzyme 2. Micardis ® is a targeted antagonist for the angiotensin-2 receptor and could enable a higher level of expression of this enzyme at the time of infection with SARS-CoV2 in order to protect patients from acute pulmonary forms. Initiating treatment with Micardis ® in patients infected with COVID-19 at an early stage of the disease could thus prevent a subsequent deterioration of their respiratory status, while at the same time being well tolerated.
AZINC Health and Vitality: This dietary supplement containing a vitamin and micronutrient complex is administered to subjects in the control arm.
With the trial being conducted in an ambulatory setting, one of our missions as pharmacy students was to pick up the drugs at the Pellegrin Hospital dispensary and prepare individual bags of medication that the mobile teams could then take to patients’ homes to include them in the trial.
E-health for optimized care
The mobile team does not include a pharmacist, so the doctor has to give the drug to the patient and provide the pharmaceutical guidance necessary to ensure the treatment is properly taken and adhered to. To manage drug interactions more effectively, the physician has access to a unique tool: a platform designed specifically for the COVERAGE trial to help with the dispensation of drugs included in the study. The platform was developed by Synapse Medicine, a technology start-up founded out of Bordeaux University Hospitals and public research organisation Inserm, specialising in the correct use of medication. The platform allows users to check whether any drugs taken by the patient on a long-term or temporary basis could interact with one of the experimental therapies of the trial and carry the risk of potentially worsening the symptoms of COVID-19. The tool also verifies the exclusion criteria, meaning the use of medications that are incompatible with participation in the clinical trial. Patients may then be excluded because of a drug they are being treated with. This not only warrants the safety of participants in the trial but also limits the study’s biases by preventing any observed efficacy from being attributed to the experimental drug if it may not be solely responsible for it.
All users need to do is enter the names of the drugs on the prescription along with the name of the experimental drug into the platform for the algorithms to provide the doctor with an instant result.
Once again, e-health is revealing itself to be a precious ally in the effort to ensure the quality of medical care and prevent an improper use of drugs
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