ScandiBio Therapeutics has initiated a Phase II study in patients with COVID-19 using Combined Metabolic Cofactors Supplementation (CMCS) consisting of L-serine, N-acetyl-L-cysteine (NAC), nicotinamide riboside (NR), and L-carnitine tartrate. A total of 100 COVID-19 patients will be randomized on a 3:1 basis to the cofactor mixture or placebo in one center. This study is planned as a Phase II clinical drug research to be conducted in patients diagnosed with COVID-19. Patients will be ambulatory and after the diagnosis/confirmation of diagnosis, will be sent home with their treatment. The primary objective is to assess the clinical efficacy of the combination of CMCS and hydroxychloroquine in COVID-19 patients. For the primary purpose, the proportion of patients who were hospitalized during the course of disease until 14 days after the initial diagnosis of Covid-19 disease will be compared. The secondary aim in this study is to evaluate the safety and tolerability of CMCS and hydroxychloroquine combination. The following secondary safety objectives have been identified in this study:
• Number / characteristics of adverse event (AE), Serious Adverse Event (SAE) and treatment discontinuation due to study drug from the beginning of the study to the end of the follow-up period
• Number / features of all changes in haematology parameters evaluated as AE from the beginning of the treatment to the end of the follow-up period.
• Number / characteristics of all changes in selected biochemical parameters evaluated as AE from the beginning of the treatment to the end of the follow-up period.
• The changes in vital signs (systolic and diastolic blood pressures, pulse, respiratory rate, body temperature, pulse oximetry values), baseline values, and the status of treatment and follow-up visits