Efficacy and safety of Ivermectin and Hydroxychloroquine in patients with severe COVID-19. A randomized controlled trial

Beltran-Gonzalez, J. L.; Gonzalez-Gamez, M.; Mendoza-Enciso, E.-A.; Esparza-Maldonado, R. J.; Hernanez-Palacios, D.; Duenas-Campos, S.; Ovalle-Robles, I.; Macias-Guzman, M. J.; Garcia Diaz, A. L.; Gutierrez Pena, C. M.; Martinez-Medina, L.; Monroy Colin, V. M.; Arreola Guerra, J. M. A.

Background In the search for active drugs against COVID19, the indications of many have been redirected. Ivermectin and Hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers. Objectives: This clinical trial analyzes the efficacy of Ivermectin and Hydroxychloroquine in patients with moderate COVID19 and in need of hospitalization. Methods. This a controlled, clinical, randomized, double blind trial that included patients with COVID-19-induced pneumonia and hospitalization criteria, but no severe respiratory failure. Patients were randomized to one of three groups: Group1 hydroxychloroquine, 400 mg every 12 hours on the first day and subsequently, 200 mg every 12 hours for 4 days, Group 2 ivermectin, 12 mg or 18 mg, according to patient weight and, Group 3 placebo. At inclusion, blood samples for arterial blood gases and biochemical markers associated with a poor prognosis were obtained. The primary outcome was established as the duration of hospitalization until discharge due to patient improvement, the total duration of hospitalization, and the safety outcomes were either respiratory deterioration or death. Results. During the month of August, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs. (plus-or-minus sign 16.9) were included, with a greater proportion of males (n=66, 62.2 %). Seventy-two percent (72%) (n= 76) had an associated comorbidity. Ninety percent (90 %) of patients were discharged due to improvement (n=96). The average duration of hospitalization was 6 days (IQR, 3 to 10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs Group 2: 6 vs Group 3: 5, p =0.43) nor in respiratory deterioration or death (Group 1: 18 % vs Group 2: 22.2 % vs Group 3: 24.3 %, p =0.83). Conclusions. In non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.