Randomized Evaluation of COVID-19 Therapy - RECOVERY (Lopinavir–Ritonavir)

Contribution To Literature:

The RECOVERY trial failed to show that lopinavir–ritonavir was superior to usual care at improving survival in hospitalized COVID-19 patients.

Description:

The goal of the trial was to evaluate lopinavir–ritonavir compared with usual care among patients admitted to the hospital with COVID-19 infection. Lopinavir is an inhibitor of HIV-1 protease and severe acute respiratory syndrome coronavirus (SARS-CoV) protease.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients admitted to the hospital with COVID-19 infection were randomized to lopinavir–ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge (n = 1,616) versus usual care (n = 3,424).

  • Total number of enrollees: 5,040
  • Duration of follow-up: 28 days
  • Mean patient age: 66 years
  • Percentage female: 40%
  • Percentage with diabetes: 27%

Inclusion criteria:

  • Patients admitted to the hospital with COVID-19 infection

Exclusion criteria:

  • Severe hepatic insufficiency
  • Use of medicinal products highly dependent on cytochrome P450 3A4 for clearance

Principal Findings:

The primary outcome, death, all-cause mortality at 28 days, occurred in 23% of the lopinavir-ritonavir group compared with 22% of the usual care group (p = 0.60). Results were the same in all subgroups.

Secondary outcomes:

  • Discharge from the hospital within 28 days: 69% of the lopinavirritonavir group compared with 70% of the usual care group (p = 0.53)
  • Need for mechanical ventilation within 28 days: 29% of the lopinavirritonavir group compared with 27% of the usual care group (p = 0.092)

Interpretation:

Among patients admitted to the hospital with COVID-19 infection, lopinavir–ritonavir was not superior compared with usual care. Lopinavir–ritonavir did not improve survival, discharge from the hospital, or need for mechanical ventilation.

References:

RECOVERY Collaborative Group. Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platform trial. Lancet 2020;Oct 5:[Epub ahead of print].

Editorial Comment: Cao B, Hayden FG. Antiviral monotherapy for hospitalized patients with COVID-19 is not enough. Lancet 2020;Oct 5:[Epub ahead of print].

Clinical Topics: Prevention, Statins

Keywords: Antiviral Agents, COVID-19, Coronavirus, HIV Protease, HIV-1, Lopinavir, Patient Discharge, Primary Prevention, Respiration, Artificial, Ritonavir, SARS Virus, Severe Acute Respiratory Syndrome, severe acute respiratory syndrome coronavirus 2


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