Trial NCT04381884
Publication Krolewiecki A, EClinicalMedicine, 2021 (published paper)
Dates: 2020-05-18 to 2020-09-09
Funding: Mixed (Agencia Nacional de Promocion de la Investigacion, el Desarrollo Tecnologico y la Innovacion, Argentina and Laboratorio ELEA/Phoenix, Argentina)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Argentina Follow-up duration (days): 30 | |
| Inclusion criteria | COVID-19 patients aged 18 to 69 years-old with RT-PCR confirmed infection;hospitalized; not requiring intensive care; COVID-19 symptoms onset ≤5 days at recruitment; absence of use of drugs with potential activity against SARS-CoV-2 (hydroxychloroquine, lopinavir, remdesivir and azithromycin);those drugs were not permitted during the first week of the trial. |
| Exclusion criteria | The use of immunomodulators within 30 days of recruitment; Pregnancy; breast feeding; Poorly controlled comorbidities; Patients of child-bearing age (men and women) were eligible if agreed to take effective contraceptive measures during the study period and for at least 30 days after the last study drug administration |
| Interventions | |
| Treatment
Ivermectin 0.6 mg/kg orally once a day for 5 days. |
|
| Control
Standard care Definition of Standard care: All patients in both groups received standard of care Duration : 5 days | |
| Participants | |
| Randomized 45 participants (n1=30 / n2= 15) | |
| Characteristics of participants N=45 Mean age : 40.9 25 males Severity : Mild: n=42 / Moderate: n=3/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Reduction in SARS-CoV-2 viral load [ Time Frame: 1 - 5 days ] | |
| In the report Difference in SARS-CoV-2 viral load between baseline and day-5 | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |
In addition to the published/pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no substantive differences between the published article and the trial registry in study procedures, population, treatments or outcomes. The study achieved its pre-stated sample size. No information is provided on what is included in standard care. There is little information on what adverse events were experienced.
On July 7th, 2021, this study was updated based on the published report. On October 6th, 2021, the study was updated based on the corrigendum. |