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

• Status: Not yet recruiting
• Trial end date: 2021-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corpometria Institute
• Treatments: Hydroxychloroquine; Ivermectin

Criteria

Inclusion Criteria:

1. Laboratory or clinically confirmed positive SARS-CoV-2 rtPCR test (AndroCoV Clinical Scoring for COVID-19 Diagnosis1) within 7 days prior to randomization

2. ≥18 years old

3. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization

4. Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3

5. Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures

6. Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study

Exclusion Criteria:

1. Subject enrolled in a study to investigate a treatment for COVID-19

2. Require oxygen use, hospitalization or mechanical ventilation

3. Tachycardia (HR > 150 bpm) or hypotension (BP < 90/60 mmHg)

4. Patients who are allergic to the investigational product or similar drugs (or any excipients);

5. Subjects with QTcF > 450 ms

6. Subjects with uncontrolled medical conditions that could compromise participation in the study - uncontrolled hypertension (BP > 220/120 mmHg), uncontrolled hypothyroidism (TSH > 10 iU/L), uncontrolled diabetes mellitus (HbA1c > 12%)

7. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.

8. Estimated glomerular filtration rate (eGFR) < 30 ml/min or requiring dialysis

9. Subject (or legally authorized representative) not willing or unable to provide informed consent