Study procedures
peripheral fasting blood sample
ADVERSE EVENTS, ADVERSE EVENT, EVENT
In the screening visit (baseline), the eligibility criteria were confirmed, a complete medical history was taken, a SARS-CoV-2 rapid antigen test was performed, a salivary sample was collected for a SARS-CoV-2 PCR test, a peripheral fasting blood sample was drawn for laboratory analyses, the informed consent was signed, and a diary and the study medication were provided. Patients were instructed on how to take the study drug and to complete the diary card, in which the hospitalization criteria were described in plain language.Telephone contacts were completed at days 1, 4, 7 and 14 after starting treatment. At the end of the study on day 28, patients were visited at the primary care centre. Saliva samples for SARS-CoV-2 PCR assay were collected on baseline at the screening visit. On days 4, 7 and 14 samples were collected from patients’ homes due to limitation of medical visits for quarantined patients. In all telephone contacts, pulse oximetry data, heart rate and temperature recorded were obtained by the patient with the study material supplied for that purpose and were registered by the physician. Questions about the appearance of new symptoms and the severity of previous and actual symptoms were assessed on a numerical rating (NRS) severity scale of 0–10 points (0 = no symptoms, 10 = the most severe symptoms imaginable). Symptoms recorded in the diary card as well as non-prescribed concomitant drugs were communicated to the physician during the telephone calls. In addition, the investigator asked the patients if they have experienced any adverse events since the last study contact, and if any exist, recorded them on the ‘Adverse Event’ case report form page and described the event. All adverse events were followed until their resolution, or chronicity.All treatments received by the patient, their dose and duration of administration were recorded in the concomitant medications section of the case report form. Throughout the study, site staff maintained adequate records of study drug dispensed, used and returned. At the end of each patient’s participation in the study, all unused medication supplies were accounted by the study monitor to check the treatment compliance.