Phase 2 clinical trial of Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients begins

This is a human phase 2 study, with add-on treatment arrangement of fluvoxamine or placebo on top of standard of care (base therapy: the actual proposed therapy of moderate SARS-CoV-2 infected patients according to "Hungarian Coronavirus Handbook", including antiviral and immunmodulant therapy and reconvalescent plasma therapy in serious cases as indicated by the investigator).

The clinical trial started in November 27, 2020 and will continue throughout December 2021.

Patients with the following conditions:

• Mild COVID-19 at randomisation (each of the followings met): no dyspnoea, respiratory rate < 22 / min, no need for oxygen supplementation, no pneumonia on medical imaging.
• Severe COVID-19 at randomisation: respiratory distress - respiratory rate ≥ 30/min, oxygen saturation at rest ≤ 93%, pulmonary infiltrates occupy > 50% of the lung-fields.
• Critical COVID-19 at randomisation: acute respiratory distress, requiring mechanical ventilation, radiomorphology of ARDS, shock, including septic shock, other organ dysfunction necessitating ICU admission.
• High-risk patient for progression of COVID-19, as defined by having a calculated pneumonia PORT-score of > 90.
• Concomitant or previous administration of any experimental, non-established COVID-19 therapy, either in off-label indication (of a registered medicinal product) or as a non-registered drug candidate in a clinical trial setting or compassionate use program (or equivalents thereof), EXCEPT therapies recommended by the "Magyar Koronavírus Kézikönyv" (Hungarian Coronavirus Manual), and as such, are considered as standard-of-care. Concomitant use of LMWHs can be considered as emerging standard-of-care, and therefore their application is not prohibited.

are excluded from participation. The full list can be viewed at the link below.

The locations of the clinical trials:

• Dél-pesti Centrumkórház, Budapest, Hungary;
• Semmelweis Egyetem Pulmonológiai Klinika, Budapest, Hungary;
• Országos Korányi Pulmonológiai Intézet, Budapest, Hungary;
• Debreceni Egyetem Kenézy Gyula Kórház Infektológia, Debrecen, Hungary.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04718480