COVID-19
Conditions
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
Interventions
Ivermectin oral suspension, 6 mg/mL
DRUGPlacebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Sponsors
Centro de Estudios en Infectogía Pediatrica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to event | 21 days | Time until resolution of symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical condition on day 5 | On day 5 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes |
| Clinical condition on day 8 | On day 8 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes |
| Clinical condition on day 11 | On day 11 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes |
| Clinical condition on day 15 | On day 15 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes |
| Clinical condition on day 21 | On day 21 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes |
| Proportion of subjects with additional care | 21 days | Proportion of subjects who require hospitalization, use of supplementary oxygen for \>24 hours or ICU admission |
| Clinical condition on day 2 | On day 2 (± 1 day) after randomization | Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes |
| Duration of additional care | 21 days | Duration of supplementary oxygen, hospitalization, ICU stay |
| Adverse events | 21 days | Proportion of subjects who develop solicited adverse events |
| Proportion of subjects who discontinue intervention | 21 days | Proportion of subjects who required discontinuation of the intervention due to adverse events |
| Time to event | 21 days | Time until deterioration of 2 or more points in an ordinal 7 points scale. |
| Duration of fever | 21 days | Number of days with fever since randomization |
| Proportion of subjects who die | From randomization up to 21 days | Proportion of subjects who die |
Countries
Colombia
Outcome results
None listed