RECOVERY trial reported hospitalized COVID-19 patients did not see a benefit compared to those patients who received usual care.
While much of the attention has weened in the discussion about hydroxychloroquine for treatment of COVID-19, results on its efficaciousness are still being published.
The ongoing RECOVERY trial reported hospitalized COVID-19 patients taking hydroxychloroquine did not have a lower mortality rate compared to those patients who received usual care.
The results of the study were published in the New England Journal of Medicine.
The RECOVERY trial is being conducted at 176 hospitals in the United Kingdom, and a randomized, controlled open-label trial comparing a range oof treatments with usual care in hospitalized COVID-19 patients, and for this segment of the trial they assigned 1561 patients to hydroxychloroquine and 3155 to receive usual care.
In terms of the treatment regimen, the patients taking hydroxychloroquine received a 200-mg tablet containing a 155-mg base equivalent in a loading dose of 4 tablets at baseline and at 6 hours, which was followed by 2 tablets (starting at 12 hours after the initial dose and then every 12 hours for the next 9 days or until discharge.
“Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P=0.15). Consistent results were seen in all prespecified subgroups of patients,” investigators wrote. “The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98).”
In fact, patient enrollment for the hydroxychloroquine group closed after an interim analysis determined a lack of efficacy according to investigators.
In addition the hydroxychloroquine group saw a higher frequency of ventilation or death (30.7% vs. 26.9%) for the usual care group. These patients were not on ventilation at baseline.
“There was a small numerical excess of cardiac deaths (0.4%) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine,” investigators wrote.
In conclusion, the investigators did not see this treatment to efficacious in hospitalized treatment, but added some caveats to other patient populations. “These findings indicate that hydroxychloroquine is not an effective treatment for hospitalized patients with Covid-19 but do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community.”