Long/Post-COVID Off-Label-Use of Drugs in Germany

Prof Bernhard Wörmann presented the work of the Long COVID Off-Label Use Expert Group of the Federal Institute for Drugs and Medical Devices (BfArM). Prof Dr Karl Lauterbach, former Federal Minister of Health, convened the expert group to enable an accelerated procedure for providing recommendations for off-label medications for Long COVID at the Federal Joint Committee (G-BA). The following evidence-based recommendations are to be made after reviewing the available clinical efficacy studies, once the G-BA has approved them, which is expected in summer 2025: Ivabadrine lowers heart rate and is recommended for Long COVID patients with Postural Tachycardia Syndrome (POTS). Vortioxetine is an antidepressant and is recommended for improving cognitive function and treating comorbid depression in Long COVID. Agomelatine is an antidepressant that binds to melatonin receptors and is recommended for reducing fatigue. Naltrexone is an opioid antagonist that can reduce fatigue at low doses (1-3 mg per day), with a recommendation for off-label use expected depending on the results of a clinical trial currently being conducted in the UK. Metformin lowers blood sugar levels and is recommended in low doses during the first three days of an acute COVID infection to reduce the risk of Long COVID (only in people over 16 years of age and with a BMI >25).