Ivermectin as a potential treatment for mild to moderate COVID-19 – A double blind randomized placebo-controlled trial

Objective: Ivermectin has been suggested as a treatment for COVID-19.This
randomised control trial was conducted to test the efficacy of Ivermectin
in the treatment of mild and moderate COVID-19. Design: Parallel, double
blind, randomised, placebo controlled trial Setting: A tertiary care
dedicated COVID-19 hospital in Bihar, India Participants: Adult patients
(> 18 years) admitted with mild to moderate COVID 19 disease
(saturation > 90% on room air, respiratory rate < 30 and no
features of shock) with no contraindications to ivermectin and willing to
participate in the study Intervention: Patients in the intervention arm
were given ivermectin 12 mg on day 1 and day 2 of admission. Patients in
the placebo arm were given identical looking placebo tablets. Rest of the
treatment was continued as per the existing protocol and the clinical
judgment of the treating teams. Outcome Measures: The primary outcome
measure was a negative RT-PCR test for SARS-CoV-2 on day 6 of admission.
The secondary outcome measures were symptom status on day 6, discharge
status on day 10, admission to ICU, need for invasive mechanical
ventilation and in-hospital mortality. Results: A total of 115 patients
were enrolled for the study of which 112 were included in the final
analysis. Of them, 55 were randomised to the intervention arm while 57
were randomised to the placebo arm. There was no significant difference in
the baseline characteristics of the two arms. There was no significant
difference in the primary outcome, i.e. negative RT-PCR status on day 6
between the two groups. Similarly, there was no significant difference
between the two groups in most of the secondary outcome measures, viz.
symptom status on day 6, discharge status on day 10, admission to ICU, and
need for invasive mechanical ventilation. However, while there was no
in-hospital mortality in the intervention arm, there were 4 deaths in the
placebo arm. As a result, all patients in the intervention arm (n=56) were
successfully discharged as compared to 93.1% (n=54/58) in the placebo arm
(RR 1.1, 95% CI 1.0 to 1.2, p=0.019). Conclusion: There was no difference
in the primary outcome i.e. negative RT-PCR status on day 6 of admission
with the use of ivermectin. However, a significantly higher proportion of
patients were discharged alive from the hospital when they received
ivermectin.