Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: a randomized controlled trial
Hernandez-Cardenas et al.,
Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: a randomized controlled..,
medRxiv, doi:10.1101/2021.02.01.21250371 (Preprint)
Very late stage RCT with 214 patients, mean SpO
2 65%, 162 on mechanical ventilation, showing no significant difference in mortality.
Patients not intubated at baseline show greater improvement, HR 0.43 [0.09-2.03].
Table 4 shows different results to the abstract - table 4 adjusted HR 0.80 [0.51-1.23], abstract HR 0.88 [0.51-1.53]. There was no significant difference in severe adverse events.
risk of death, 12.0% lower, RR 0.88, p = 0.66, treatment 106, control 108.
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risk of death, 57.0% lower, RR 0.43, p = 0.29, subgroup not intubated at baseline.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Hernandez-Cardenas et al., 5 Feb 2021, Randomized Controlled Trial, Mexico, preprint, 6 authors, average treatment delay 7.4 days.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.02.01.21250371; this version posted February 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
HCQ for severe COVID-19
HYDROXYCHLOROQUINE FOR THE TREATMENT OF SEVERE RESPIRATORY
INFECTION BY COVID-19: A RANDOMIZED CONTROLLED TRIAL
AUTHORS: Carmen Hernandez-Cardenas1, Ireri Thirion-Romero1, Norma E. RiveraMartinez2, Patricia Meza-Meneses3, Arantxa Remigio-Luna1, Rogelio Perez-Padilla1 on
behalf of the Research Group on hydroxychloroquine for COVID-19 *
*The research group also formed by Drs. Luis Felipe Jurado-Camacho1, Sebastián RodríguezLlamazares1, Teresa Aguirre-Pérez1, Joel Armando Vásquez-Pérez1, and Alejandra RamirezVenegas1, from the Instituto Nacional de Enfermedades Respiratorias Mexico City, and Drs.
Gabriela Tapia-Pastrana2, Nestor G. Cruz-Ruiz2 from the Hospital de Referencia de Alta
Especialidad Oaxaca.
1- Instituto Nacional de Enfermedades Respiratorias; CP 14080, Mexico City, Mexico.
2- Hospital Regional de Alta Especialidad Oaxaca; CP 71256, Oaxaca, Mexico.
3-Hospital Regional de Alta Especialidad Ixtapaluca; CP 53560, Edo de México, Mexico.
Correspondence: Dr. Rogelio Perez Padilla, Instituto Nacional de Enfermedades
Respiratorias, Mexico City.
e-mail perezpad@gmail.com
1
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2021.02.01.21250371; this version posted February 5, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
HCQ for severe COVID-19
ABSTRACT
The novel coronavirus pandemic (COVID–19) represents a major public health problem due to
its rapid spread and its ability to generate severe pneumonia. Thus, it is essential to find a
treatment that reduces mortality. Our objective was to estimate whether treatment with 400
mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe
respiratory disease due to COVID-19 compared with placebo.
Material and methods: A double-blind, randomized, placebo-controlled trial to evaluate the
safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19
through an intention-to-treat analysis. Eligible for the study were adults aged more than 18
years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or
without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes:
days of mechanical ventilation, days of hospitalization and cumulative incidence of serious
adverse events.
Results: A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They
were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and
tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day
mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard
ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51-1.53). In the surviving participants, no
significant difference was found in secondary..
Late treatment
is less effective
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