Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial.

Objectives: The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the pharmacokinetic and pharmacodynamic profile of this drug and mechanisms of resistance in the context of COVID-19 infection, as well as the effect of favipiravir on hospitalisation duration and the post COVID-19 health and psycho-social wellbeing of patients recruited to the study.

Trial Design: GETAFIX is an open label, parallel group, two arm phase II/III randomised trial with 1:1 treatment allocation ratio.

Vancomycin continuous infusion as prophylaxis for vascular surgery.

Prosthetic graft infection is a devastating complication of vascular surgery that occurs in 3%-5% of clean prosthetic procedures. Staphylococci are the most frequently isolated pathogens, and thus surgical prophylaxis regimens often include vancomycin. However, the efficacy of these regimens in ensuring a required concentration of antibiotic is uncertain.

Population pharmacokinetics of hydroxychloroquine in patients with rheumatoid arthritis.

Hydroxychloroquine (HCQ) is an antimalarial drug that is also used as a second-line treatment of rheumatoid arthritis (RA). Clinically, the use of HCQ is characterized by a long delay in the onset of action, and withdrawal of treatment is often a result of inefficacy rather than from toxicity. The slow onset of action can be attributed to the pharmacokinetics (PK) of HCQ, and wide interpatient variability is evident.

Combination therapy with methotrexate and hydroxychloroquine for rheumatoid arthritis increases exposure to methotrexate.

Objective: To examine the bioavailability of methotrexate (MTX) in the presence of hydroxychloroquine (HCQ), and vice versa, to determine a possible pharmacokinetic explanation for the observation that combination treatment of rheumatoid arthritis with MTX and HCQ has been shown, clinically, to be more potent than MTX used alone.

Methods: In a randomized crossover study, 10 healthy subjects received, on each of 5 dosing occasions, MTX alone as tablets or intravenous solution, HCQ alone as a tablet or oral solution, or a coadministered dose of MTX tablets with an HCQ tablet. The area under the concentration-time curve (AUC) was determined for each subject, on each dosing occasion, for each compound.