May - 2020
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Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19
New Eng J Med, 2020, Online May
The antimalarial agents chloroquine and hydroxychloroquine did not expect to make headlines this century, but COVID-19 has changed everything.
On March 30, 2020, the US FDA approved their use for COVID-19 in patients not enrolled in clinical trials, following an open label trial of hydroxychloroquine (200mg tds x 10/7) use in 26 COVID-19 patients from France reporting reduction in viral burden at day 5 (65% vs 19% clearance).
This prospective observational study reports the association between hydroxychloroquine use and risk of the composite endpoint of intubation or deaths in patients with COVID-19 in a New York City Medical Center.
Overall this observational propensity matched study of hydroxychloroquine use in patients with COVID-19 and moderate-severe respiratory illness, reported no association of benefit or harm with relation to primary outcome or death or intubation.
Hydroxychloroquine has been widely administered to patients with Covid-19 with- out robust evidence supporting its use.
We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City. Data were obtained regarding consecutive patients hospitalized with Covid-19, excluding those who were intu- bated, died, or discharged within 24 hours after presentation to the emergency department (study baseline). The primary end point was a composite of intubation or death in a time-to-event analysis. We compared outcomes in patients who re- ceived hydroxychloroquine with those in patients who did not, using a multivariable Cox model with inverse probability weighting according to the propensity score.
Of 1446 consecutive patients, 70 patients were intubated, died, or discharged within 24 hours after presentation and were excluded from the analysis. Of the remaining 1376 patients, during a median follow-up of 22.5 days, 811 (58.9%) received hydroxy- chloroquine (600 mg twice on day 1, then 400 mg daily for a median of 5 days); 45.8% of the patients were treated within 24 hours after presentation to the emergency department, and 85.9% within 48 hours. Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloro- quine (median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen, 223 vs. 360). Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32). Results were similar in multiple sensitivity analyses.
In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed.
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