The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial)
Status:
Not yet recruiting
Trial end date:
2021-04-20
Target enrollment:
Participant gender:
Summary
Ivermectin, a classical antiparasitic and anti-scabies agent, has demonstrated antiviral
activity for a variety of viruses including chikungunya virus, zyka virus and dengue virus
and was tested as a potentially effective for COVID-19.
Although ivermectin demonstrated potent in vitro action by reducing viral load by 5000x after
48 hours of incubation, simultaneous pharmacokinetics simulations suggested that the minimum
effective concentrations would be unfeasible to be reached within safety range (EC-50 = 2
Micromol).
However, despite the theoretical unfeasible concentrations to be achieved, preliminary
observational yet well-structured studies followed by randomized clinical trials (RCTs)
demonstrated ivermectin efficacy when combined with hydroxychloroquine, doxycycline or
azithromycin, which was corroborated by a recent systematic review and metanalysis. In
common, a dose-response effect for effectiveness was observed, and no adverse effects was
reported at any dose between 0.2mg/kg/day and 1.0mg/kg/day.
Based on the scientific rationale combined with the preliminary evidence, ivermectin has
sufficient evidence to be tested in higher doses in a RCT for COVID-19. The investigators
propose to test ivermectin at high doses as a treatment for patients recently diagnosed with
COVID-19, aiming to explore the possible protective role of high-dose ivermectin in
SARS-CoV-2 infection in terms of reduction of clinic and virologic disease duration, and
prevention of oxygen use, hospitalization, mechanical ventilation, death, and post-COVID
persisting symptoms.