Randomization and intervention
thrombosis, bacterial coinfection/superinfection, SARS-CoV-2 infection, asthma, blisters
THROMBOSIS, SARS-COV-2 INFECTION, DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA
Randomization was generated by an independent technician using a web-based randomization system (Patients received domperidone three daily doses of 10 mg (30 mg/day) for 7 days, plus standard of care (SOC) treatment or matching placebo. A box containing two blisters with 12 tablets were provided to each patient. Since the efficacious daily dose of the active product with viral load reduction capacity was unknown, the maximum labelled dose of the marketed product (10 mg three times daily equal to 30 mg/day for 7 days) was analysed. Dose increasement was not allowed. Labelling and packing of domperidone and placebo followed the GMP regulations and local or national regulatory requirements.The SOC for SARS-CoV-2 infection included acetaminophen 500 mg (1–4 times daily), non-steroidal anti-inflammatory drugs, symptomatic treatment and hydration for mild COVID-19. In moderate disease only in case of suspicion of bacterial coinfection/superinfection, the following should be prescribed: amoxicillin-clavulanate 875–125 mg every 8 h for 7 days; or alternatively, levofloxacin 500 mg every 12 h on the first day and 500 mg every 24 h for 4 days. Other treatments when required included bronchodilators or inhaled corticosteroids in patients with asthma or chronic obstructive pulmonary disease. Low doses of systemic corticosteroids in patients requiring oxygen therapy and antithrombotic prophylaxis in patients immobilized or with risk factors for thrombosis were allowed [