Status:
UNKNOWN
The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial)
Lead Sponsor:
Corpometria Institute
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Overall COVID-19 is a multisystemic disease caused by SARS-CoV-2 that has become a pandemic largely due to a combination of favorable transmission and infection characteristics for its spread, includ...
Eligibility Criteria
Inclusion
- Laboratory or clinically confirmed positive SARS-CoV-2 rtPCR test (AndroCoV Clinical Scoring for COVID-19 Diagnosis1) within 7 days prior to randomization
- ≥18 years old
- Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
- Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3
- Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
- Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study
Exclusion
- Subject enrolled in a study to investigate a treatment for COVID-19
- Require oxygen use, hospitalization or mechanical ventilation
- Tachycardia (HR \> 150 bpm) or hypotension (BP \< 90/60 mmHg)
- Patients who are allergic to the investigational product or similar drugs (or any excipients);
- Subjects with QTcF \> 450 ms
- 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%)
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min or requiring dialysis
- Subject (or legally authorized representative) not willing or unable to provide informed consent
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 20 2021
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04712279
Start Date
January 25 2021
End Date
April 20 2021
Last Update
January 15 2021
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