COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04530474

Derek Isenberg, MD

derek.isenberg@tuhs.temple.edu

2020-08-28

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: symptoms highly suspicious for covid-19. age at least 18 years negative pregnancy test for women of child bearing age able to consent to participate in the study.

known history of ivermectin allergy hypersensitivity to any component of stromectol® covid-19 pneumonia identified by chest x-ray or high resolution ct scan fever or cough present for more than 7 days positive igg against sars-cov-2 by rapid test if available on baseline screening. the following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study: immunosuppression hiv acute or chronic renal failure current neoplasm alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal within the prior 6 months if available or clinical evidence of liver failure with jaundice, ascites, encephalopathy. current use of cyp 3a4 or p-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. use of critical cyp3a4 substrate drugs such as warfarin.

2

Temple University

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

0

Clinical Improvement

None

Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]