Hospitalised patients in North East England with COVID-19 are the first to receive antibodies

Patients admitted to a hospital trust in North East England with COVID-19 are the first to receive synthetic neutralising antibodies, as part of the Randomised Evaluation of COVID-19 therapy (RECOVERY) study.

As part of its involvement in the trial, overseen by the University of Oxford, North Tees and Hartlepool NHS Foundation Trust introduced REGN-COV2, which combines two antibodies that bind to SARS-COV-2, blocking the entry into host cells.

The trust’s pharmacy clinical trials and aseptic team are accountable for assuring regulatory agreement with the use of the unlicensed drug, appropriate storage, its receipt, documentation and preparation.

RECOVERY trial researchers predict that as many as two thousand hospitalised patients will be randomly assigned to receive REGN-COV2, as well as to obtain the usual standard of treatment. This is in comparison to as many as two-thousand hospitalised patients who receive standard-of-care on its own.

Twenty-eight days after randomisation, the researchers will assess the effect of treatment on mortality, as well as its effect on hospital stays and the need for ventilation.

Associate Chief Pharmacists in the trust’s aseptic service, Bill Wetherill, stated: “Together, the team has carried out a significant amount of work to ensure every measure was taken so that this treatment could be delivered to patients. There have been a number of challenges to overcome. This is an experimental drug and, although the likely risks of handling the drug are known until we have definite proof of its safety in terms of handling, we are preparing the dose within our safety cabinets in the pharmacy clean rooms. This allows the product to be protected from contamination, and be prepared in an aseptic way but also ensures protection of the operator from the product in case there are risks we are not yet aware of. It also protects nursing staff and patients on the ward from these risks.”

Chief pharmacist at the trust and director of medicines optimisation, Mojgan Sani, stated: “The aseptic manufacturing team have played a critical role in helping the trust be the first in the country to offer this medication to patients.”