Trial NCT04381884
Publication Krolewiecki A, SSRN, 2020 (preprint)
Dates: 2020-05-18 to 2020-09-29
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 | 1) COVID-19 patients aged 18 to 69 years-old with RT-PCR confirmed infection
2) Hospitalized with disease stages 3 to 5 from the WHO 8-Category ordinal scale of clinical status 3) Not requiring intensive care unit admission 4) COVID-19 symptoms onset ≤5 days at recruitment 5) Absence of use of drugs with potential activity against SARS-CoV-2 and available in Argentina during the trial (hydroxychloroquine, chloroquine, lopinavir and azithromycin); and those drugs were not permitted during the first week of the trial. 6) Patients of child-bearing age (men and women) were eligible if agreed to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 30 days after the last study drug administration. |
| Exclusion criteria | 1) The use of immunomodulators within 30 days of recruitment
2) Pregnancy, breast feeding 3) Poorly controlled comorbidities 4) Known allergies to IVM |
| Interventions | |
| Treatment
Ivermectin (0.6 mg/kg)Co-Intervention: Standard care Duration : 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 Reduction 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 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 pre-print 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. |