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
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
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
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--