A Randomized, Double-blind, Placebo-controlled, Adaptive-design Study to Assess the Safety and Efficacy of Daily 200 mg Fluvoxamine as add-on Therapy to Standard of Care in Moderate Severity COVID-19 Patients
This is a randomized, double-blind, placebo-controlled, adaptive two-stage design, 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).
• Males and females 18-70 years of age at screening
• Hospitalized patients with confirmed SARS-CoV-2 by PCR or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending (positive PCR result should be available prior to randomisation).
• Moderate cases (each of the followings met): showing dyspnoea but not manifest respiratory distress, respiratory rate 22-29 / min; oxygen saturation at rest \> 93%; with or without the need for oxygen supplementation; pneumonia on medical imaging with pulmonary infiltrates occupying ≤ 50% of the lung-fields
• Subjects who are able to communicate with the Investigator and research staff, who understand the study, are able to comply with all study procedures, and willing to provide written informed consent prior to the screening examinations.