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An open-label randomized controlled trial evaluating the efficacy of chloroquine/hydroxychloroquine in severe

Álvaro Réa-Neto1, Rafaella Stradiotto Bernardelli2, Bruna Martins Dzivielevski Câmara2

  • 1Federal University of Paraná (UFPR); CEPETI, Center for Study and Research in Intensive Care Medicine, Rua Monte Castelo, 366, Curitiba, CEP, 82590-300, Brazil. reaneto@uol.com.br.

Scientific Reports
|April 28, 2021
PubMed

Insights

Chloroquine and hydroxychloroquine did not improve outcomes for severe COVID-19 patients. Adding these drugs to standard care worsened clinical status and increased risks of renal dysfunction and mechanical ventilation.

Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • Critical Care Medicine

Background:

  • Efficacy of chloroquine and hydroxychloroquine for COVID-19 remains uncertain, particularly in severe cases.
  • Standard care alone is the benchmark for treating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • Investigating repurposed drugs for novel viral infections is crucial.

Purpose of the Study:

  • To assess the efficacy and safety of chloroquine or hydroxychloroquine combined with standard care versus standard care alone in hospitalized severe COVID-19 patients.
  • To evaluate the impact on clinical status, mortality, mechanical ventilation, and renal dysfunction.
  • To identify potential harmful effects associated with these drug combinations.

Main Methods:

  • Randomized, open-label, controlled, phase III trial involving 105 patients with severe COVID-19.
  • Intervention group received chloroquine or hydroxychloroquine for five days alongside standard care.
  • Primary outcome: clinical status on day 14; secondary outcomes: mortality, mechanical ventilation, renal dysfunction, and clinical status at multiple time points.

Main Results:

  • The trial was halted early due to harmful effects in the intervention group.
  • Patients receiving chloroquine/hydroxychloroquine showed worse clinical outcomes on days 14 and 28.
  • Increased incidence of invasive mechanical ventilation and severe renal dysfunction (KDIGO stage 3) was observed in the intervention group.

Conclusions:

  • Chloroquine/hydroxychloroquine added to standard treatment significantly worsened clinical status in severe COVID-19.
  • The combination therapy increased the risk of renal dysfunction and the need for invasive mechanical ventilation.
  • These findings suggest that chloroquine and hydroxychloroquine are not beneficial and may be harmful for severe COVID-19 patients.

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