Official Title
Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19
Brief Summary

Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19

Completed
COVID-19

Drug: Ivermectin Oral Product

Ivermectin oral suspension, 6 mg/mL

Drug: Placebo

Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Eligibility Criteria

Inclusion Criteria:

- At least 18 years of age

- Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved
laboratory

- Beginning of symptoms in the past 7 days

- Mild disease

- Informed consent

Exclusion Criteria:

- Preexisting liver disease

- Hypersensitivity to ivermectin

- Participants in other clinical trials for therapies against COVID-19

- Severe pneumonia

- Pregnant or breastfeeding women

- Concomitant use of warfarin, erdafitinib or quinidine

- Use of ivermectin in the 5 days prior to randomization

- Inability to obtain a blood sample needed to assess liver transaminases

- Elevation of transaminases >1.5 times the normal level

- Participant whose first contact with the study personnel occurs between days 5 and 7
and at that time manifests significant and progressive resolution of COVID-19 related
signs and symptoms

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Colombia
Locations

Centro de Estudios en Infectología Pediátrica
Cali, Valle, Colombia

Eduardo López-Medina, MD MSc, Principal Investigator
Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--

Centro de Estudios en Infectogía Pediatrica
NCT Number
MeSH Terms
COVID-19
Ivermectin