Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IVE-PA | Other Identifier | INVIMA (Colombian Regulatory Agency) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | Ivermectin, 300 micrograms / kg, once daily for 5 days |
|
| Placebo | Placebo Comparator | Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Oral Product | Drug | Ivermectin oral suspension, 6 mg/mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to event | Time until resolution of symptoms | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical condition on day 2 | Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes | On day 2 (± 1 day) after randomization |
| Clinical condition on day 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eduardo López-Medina, MD MSc | Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP-- | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Estudios en Infectología Pediátrica | Cali | Valle del Cauca Department | 12345 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33662102 | Derived | Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient |
|
Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
| On day 5 (± 1 day) after randomization |
| Clinical condition on day 8 | Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes | On day 8 (± 1 day) after randomization |
| Clinical condition on day 11 | Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes | On day 11 (± 1 day) after randomization |
| Clinical condition on day 15 | Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes | On day 15 (± 1 day) after randomization |
| Clinical condition on day 21 | Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes | On day 21 (± 1 day) after randomization |
| Proportion of subjects with additional care | Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission | 21 days |
| Proportion of subjects who die | Proportion of subjects who die | From randomization up to 21 days |
| Duration of additional care | Duration of supplementary oxygen, hospitalization, ICU stay | 21 days |
| Adverse events | Proportion of subjects who develop solicited adverse events | 21 days |
| Proportion of subjects who discontinue intervention | Proportion of subjects who required discontinuation of the intervention due to adverse events | 21 days |
| Time to event | Time until deterioration of 2 or more points in an ordinal 7 points scale. | 21 days |
| Duration of fever | Number of days with fever since randomization | 21 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |