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May - 2020

   

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Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19

J Geleris,Y Sun, J Platt, et al New Eng J Med, 2020, Online May

Comment

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. 

  • Participants: Hospitalised adults with SARS-CoV-2 positive NP/OP swabs. The results include 811 patients who received HQ, and 274 propensity matched NoHQ.
  • Treatment: A hospital guideline suggested hydroxychloroquine - 600mg BD D1, 400mg D2-5. Azithromycin was suggested as additional option, but this was removed in April - as a treatment option for patients with COVID-19 and moderate to severe respiratory illness (SpO2 <94%)
  • Analysis: Propensity-score matching was performed to match hydroxychloroquine patients with non-treated patients. After matching they were similar, although marked difference in systematic glucorticoid  (HQ 27% vs NoHQ 15%), azithromycin (60% vs 37%), tocilizumab (7% vs 3%) exposure, and PF ratio (HQ 223 vs NoHQ 273), ferritin. 
  • Primary outcome: Over a median follow up of 22.5 days, 25% (346) patients had the primary outcome (180 intubated and 166 died without intubation). In the primary multivariate analysis with inverse probability weighting according to the propensity score, there was no association between hydroxychloroquine use and the primary outcome (HR 1.04, 95% CI 0.82-1.32).
  • Additional multivariate analysis revealed similar to results. 

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.

 

Abstract

BACKGROUND

Hydroxychloroquine has been widely administered to patients with Covid-19 with- out robust evidence supporting its use.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

May


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