Safety, tolerability, and clinical outcomes of hydroxychloroquine for hospitalized patients with coronavirus 2019 disease

Abstract

Background Severe acute respiratory coronavirus 2 (SARS-CoV-2) has caused a devastating worldwide pandemic. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2, but clinical data supporting HCQ for coronavirus disease 2019 (COVID-19) are limited. Methods This was a retrospective cohort study of hospitalized patients with COVID-19 who received �1 dose of HCQ at two New York City hospitals. We measured incident Grade 3 or 4 blood count and liver test abnormalities, ventricular arrhythmias, and vomiting and diarrhea within 10 days after HCQ initiation, and the proportion of patients who completed HCQ therapy. We also describe changes in Sequential Organ Failure Assessment hypoxia scores between baseline and day 10 after HCQ initiation and in-hospital mortality. Results None of the 153 hospitalized patients with COVID-19 who received HCQ developed a sustained ventricular tachyarrhythmia. Incident blood count and liver test abnormalities occurred in <15% of patients and incident vomiting or diarrhea was rare. Eighty-nine percent of patients completed their HCQ course and three patients discontinued therapy because of QT prolongation. Fifty-two percent of patients had improved hypoxia scores 10 days after starting HCQ. Thirty-one percent of patients who were receiving mechanical ventilation at the time of HCQ initiation died during their hospitalization, compared to 18% of patients who were receiving supplemental oxygen but not requiring mechanical ventilation, and 8% of patients who were not requiring supplemental oxygen. Co-administration of azithromycin was not associated with improved outcomes.

Reações adversas a medicamentos em pacientes com COVID-19 no Brasil: análise das notificações espontâneas do sistema de farmacovigilância brasileiro

“…However, COVID-19 and its consequences are still little known, and greater monitoring of these severe ADRs is necessary to better understand this result. In general, our findings corroborate the results of other studies, especially those evaluating the safety of hydroxychloroquine and chloroquine 2,3,4,17 , which identified the association of these drugs and severe ADR, leading to deaths.…”

“…The main sites of manifestation of the reactions we identified are similar to those verified in other studies of ADR in patients with COVID-19: cardiac, gastrointestinal, cutaneous and hepatobiliary systems 15,16,17,21,22 . Prolongation of the QT interval favors the appearance of cardiac arrhythmias, ventricular fibrillation, torsade de pointes and sudden cardiac death 16,22,23 .…”

“…The characteristics of the participants were similar to other studies 4,5,15,16,17 with this same theme, with the prevalence of men, patients over 60 years of age, with concomitant diseases and using multiple drugs.…”

Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for Covid-19 Outpatients in Saudi Arabia

“…Similarly, Lofgren et al reported a higher frequency of side effects (84%) and medication side effects (27%) among hydroxychloroquine recipients mainly; upset stomach (25% with daily, 18% with twice vs 23% for daily, 16% twice weekly for placebo), nausea (12% weekly, vs 6% for placebo) followed by diarrhoea, vomiting, or abdominal pain (11). This finding was inconsistent with Satlini et al, who found that patients with incident vomiting or diarrhoea were rare (12).…”

Predictors of QT Interval Prolongation in Critically-ill Patients with SARS-CoV-2 Infection Treated with Hydroxychloroquine

“…Several reports did not show improvement in clinical status under chloroquine or HCQ treatment for patients with SARS-CoV-2 infection 21,22,28 . Consequently, these drugs are not approved as first line therapy for SARS-CoV-2 infection in Brazil anymore.…”