Trial NCT04391127
Publication Beltran-Gonzalez J, 2021 (preprint)
Dates: 5/4/2020 to 8/15/2020
Funding: Public/non profit (Aguascalienes State Health Institute)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Mexico Follow-up duration (days): * | |
| Inclusion criteria | Age 16 to 90 years; hospitalized; positive RT-PCR for SARS-CoV-2 by nasal and oropharyngeal swabbing; pneumonia, diagnosed by X-ray or high-resolution chest CT scan, with a pattern suggesting involvement due to coronavirus; recently established hypoxemic respiratory failure or acute clinical deterioration of pre-existing lung or heart disease. |
| Exclusion criteria | Required high oxygen volumes (face mask > 10 L/ min) ; had predictors of a poor response to high-flow oxygen nasal prong therapy ; required mechanical ventilation |
| Interventions | |
| Treatment 1 Ivermectin | |
| Control Placebo | |
| Treatment 3 Hydroxychloroquine | |
| Participants | |
| Randomized 106 participants n1=36/ n2=37/ n3=33 | |
| Characteristics of participants N=106 Mean age : 53 66 males Severity : Mild: n=0 / Moderate: n=16/ Severe: n=90 Critical: n=0 | |
| Primary outcome | |
| In the register Mean days of hospital stay [ Time Frame: Three months ]; Rate of Respiratory deterioration, requirement of invasive mechanical ventilation or dead [ Time Frame: Three months ]; Mean of oxygenation index delta [ Time Frame: Three months ] | |
| In the report Hospitalization duration until discharge due to clinical improvement, the total duration of hospitalization, and the safety outcomes were duration of hospitalization until respiratory deterioration (previously defined) or death | |
| Documents available |
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. Inclusion criteria in registry and the pre-print article differ slightly in that the pre-print article also included hypoxemic respiratory failure or acute clinical deterioration of pre-existing lung or heart disease. Some pre-stated primary (i.e., mean of oxygenation index delta) and secondary (i.e., mean time to negative PCR) outcomes were not reported. There were no substantive differences between the pre-print article and the trial registry in interventions. Patients considered at high risk of development of QT interval prolongation due to hydroxychloroquine were only randomized to the ivermectin or placebo arms. The trial was terminated due to a reduction in eligible participants. As a result, the target sample size was not achieved. |