RE: Traumakine16 Jun 2020 15:53
Trials: High-profile trials of lopinavir-ritonavir are evaluating the drug alone and in combination with other COVID-19 therapeutic candidates.
Tongji Hospital (Recruiting): A Phase 4 randomized controlled trial of lopinavir-ritonavir is evaluating the drug against arbidol hydrochloride and oseltamivir (NCT04255017).
A study in South Korea is pitting lopinavir-ritonavir against hydroxychloroquine in patients with mild cases of COVID-19 (NCT04307693),
Lopinavir-ritonavir alone and in combination with interferon-beta are two arms of the WHO SOLIDARITY trial.
The UK-based RECOVERY trial is also evaluating lopinavir-ritonavir in one of its treatment arms.
Lopinavir and ritonavir are also being evaluated together with abacavir and lamivudine as the drug QuadraMune in up to 500 patients with COVID-19 in a trial sponsored by Therapeutic Solutions International (NCT04421391).
Outcomes: Findings are beginning to indicate that lopinavir-ritonavir may not result in clinical improvement from COVID-19.
Evidence for use: A study published in The Lancet of 127 patients randomized 2:1 to receive a combination of interferon beta-1b, lopinavir–ritonavir and ribavirin, or lopinavir–ritonavir alone and found the combination therapy was more effective than treating with lopinavir–ritonavir on its own.
Evidence showing no benefit: A randomized, controlled trial published in the New England Journal of Medicine showed no therapeutic benefit for lopinavir-ritonavir in patients with cases of severe COVID-19. After publication of this trial, some researchers have noted clinicians have stopped using the therapy. A journal pre-proof study by researchers from Guangzhou Medical University in China published in the journal Med found no difference in COVID-19 outcomes between 34 patients who received lopinavir-ritonavir, 35 patients who received arbidol and 17 patients who took no antiviral medication. “Our findings suggest that we need to cautiously consider before using these drugs,” the researchers said in a press release.
Status: The trial from researchers in South Korea is expected to be completed in May. The Tongji Hospital study is expected to be completed by July. Trial completion dates of the studies based in China vary, with the earliest completion dates listed in late April. SOLIDARITY is currently recruiting.
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