The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial)

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.

Conditions

• Covid19

Interventions

DRUG

Ivermectin 0.6mg/kg/day

Use of ivermectin 0.6m/kg/day q.d.for 05 days

DRUG

Ivermectin 1.0mg/kg/day

Ivermectin 1.0mg/kg/day q.d. for 05 days

DRUG

Placebo

Placebo q.d.for 05 days

DRUG

Hydroxychloroquine

Hydroxychloroquine 200mg/day q.d. for 05 days

Sponsors & Collaborators

• Corpometria Institute

  lead OTHER

Principal Investigators

• Ricardo A Zimerman, MD · Corpometria Institute

• Flavio A Cadegiani, MD, PhD · Corpometria Institute; Applied Biology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2021-03-21

Completion

2021-04-20