Lidocaine Treatment for Long COVID — What You Need to Know

No, the treatment is not currently reimbursed. The current costs amount to approximately 3,000 euros per month, which are currently paid by the patient themselves. However, it is expected that costs will decrease substantially when production can take place on a larger scale. Excellent Care Clinics is working on further steps towards broader availability and reimbursement.

No. This concerns a dispensed pharmacy preparation: a standard procedure whereby, in collaboration between the treating physician and the pharmacist, an existing registered active substance (lidocaine) is prepared with an excipient for a specific dosage form. The active molecule (API) remains unchanged. This therefore means no new molecule and no new active substance.

This question is understandable. The pharmacy preparation of lidocaine with HP-β-cyclodextrin is not (yet) reimbursed by health insurers, causing patients and doctors to look for cheaper alternatives.

However, standard lidocaine infusion fluid is not suitable for this.

In pain medicine, this form of lidocaine is administered exclusively in a hospital setting, under continuous medical supervision. Administration via infusion or injection (intravenous or subcutaneous) can lead to excessively high lidocaine blood levels, with the risk of serious side effects. Therefore, this treatment takes place only in a clinical setting.

Moreover, for virtually all pulmonary COVID patients, repeatedly coming to the hospital is too burdensome. To enable safe home treatment, a modified formulation has therefore been developed in which the excipient hydroxypropyl-β-cyclodextrin (HP-β-CD) has been added to lidocaine.

The aim of this formulation is that lidocaine, after subcutaneous administration, is preferably absorbed via the lymphatic system and less into the bloodstream, enabling patients to safely self-inject it at home. Additionally, HP-β-CD makes the injections less painful and allows the active dose to be administered in a smaller injection volume, which further reduces the risk of absorption into the bloodstream.

The safety, side effects, and outcomes of this modified lidocaine treatment were investigated in 103 patients with pulmonary COVID, who were monitored intensively and daily. These data have recently been scientifically published.

In contrast, the home injection of standard lidocaine infusion fluid has not been studied and is strongly advised against for safety reasons. General practitioners and medical specialists are therefore advised to administer lidocaine infusion fluid exclusively within the hospital.

There is indeed follow-up after stopping or tapering off treatment. The published results run until April 2025; we have continued following these patients since then. We are currently preparing a follow-up publication with data up to 66 weeks. Preliminary analyses show that the positive effects on both physical and mental health remain stable in many cases or even increase further, and that a significant proportion of patients have been able to taper off or completely stop the medication without a relapse to their previous level of symptoms.

At the same time, precisely because of the impact of these findings, we consider it important to confirm and refine the results in a formal, placebo-controlled Randomized Controlled Trial. Such an RCT is currently being prepared.

The skin reactions that may occur with daily subcutaneous injections are classified as "mild side effects" in the article because they do not cause permanent damage. In clinical research, side effects are classified according to severity: mild, moderate, or severe (severity grading). Skin reactions such as redness, swelling, bruising, or hardening fall into the category of mild adverse events.

This does not mean that these symptoms cannot be bothersome for patients. However, many patients did not find the skin reactions resulting from the daily injections bothersome in proportion to the perceived improvement in their symptoms. The skin problems usually disappear within a few weeks to months after tapering off or stopping the injections.

Skin reactions are to be expected with frequent subcutaneous injections, as is also known with, for example, insulin or anticoagulant treatments. However, these reactions do require attention. Over time, various strategies have been implemented to support the skin as effectively as possible and minimize problems, such as cooling, massage, lymphatic drainage, the use of grid dressings, and regularly rotating injection sites.

In the study, we describe the results up to and including 36 weeks after the start of treatment, but in practice, the duration of treatment varies per patient. Patients are typically treated for several months; treatment is continued until the patient has stably recovered to approximately 80% of pre-onset disease functioning. At that point, tapering off and, where possible, discontinuation are started in consultation between the patient and the treating physician.

The treatment consists of subcutaneous injections of lidocaine-HP-β-CD, which patients administer themselves at home according to a fixed schedule. During the treatment, they are intensively monitored: patients report the severity of their symptoms daily via a web application, complete more extensive questionnaires at fixed intervals, and attend a clinical check-up approximately every six weeks. This allows the course of symptoms, the timing of tapering, and the safety of the treatment to be closely monitored.