Trial NCT04391127
Publication Beltran-Gonzalez J, medRxiv (2021) (preprint)
Dates: 2020-05-04 to 2020-08-15
Funding: Public/non profit (Aguascalienes State Health Institute)
Conflict of interest: No

Methods
RCT
Blinding: Double blinded, no restrictions
Location : Single center / Mexico
Follow-up duration (days): 30
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
Hydroxychloroquine
Initial dose: 400 mg orally twice a day for the first day.
Maintenance dose: 200 mg orally twice a day for another 4 days.

Ivermectin
12 mg for one day in patients weighing < 80 kg and 18 mg for one day in those >80 kg.

Control
Placebo
Two calcium citrate tablets orally twice a day for one day. Subsequently one tablet twice a day for 4 more days.

Participants
Randomized
participants :
Hydroxychloroquine=33
Ivermectin=36
Placebo=37
Characteristics of participants
N= 106
Mean age : NR
66 males
Severity : Mild: n=0 / Moderate: n=16 / Severe: n=90 Critical: n=0
Number of vaccinated participants: NR
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 willing stated in the publication:

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.
This trial was updated on July 28th, 2021 with data gained from contact with authors.