Oslo, Norway—Neither remdesivir nor hydroxychloroquine (HCQ) appeared to have any effect on viral clearance in COVID-19 patients.

That’s according to NOR-Solidarity, an independent, add-on, randomized, controlled trial to the World Health Organization (WHO) Solidarity trial. The earlier WHO trial found no effect of remdesivir or HCQ on mortality but did not assess antiviral effects of the drugs.

Results were reported recently in Annals of Internal Medicine.

Emphasizing, “New treatment modalities are urgently needed for patients with COVID-19,” the study team sought to evaluate the effects of remdesivir and HCQ on all-cause, in-hospital mortality. Researchers also focused on the degree of respiratory failure and inflammation; as well as viral clearance in the oropharynx.

The trial was conducted in 23 hospitals in Norway; participants included adults hospitalized with confirmed SARS-CoV-2 infection.

Between March 28 and Ocober 4, 2020, researchers randomly assigned 181 patients to receive either remdesivir, HCQ, or standard-of-care (SoC).

“No significant differences were seen between treatment groups in mortality during hospitalization,” the authors advise. “There was a marked decrease in SARS-CoV-2 load in the oropharynx during the first week overall, with similar decreases and 10-day viral loads among the remdesivir, HCQ, and SoC groups. Remdesivir and HCQ did not affect the degree of respiratory failure or inflammatory variables in plasma or serum. The lack of antiviral effect was not associated with symptom duration, level of viral load, degree of inflammation, or presence of antibodies against SARS-CoV-2 at hospital admittance.”

In February 2020, a WHO expert group recommended that four drugs approved for other indications—hydroxychloroquine (HCQ), remdesivir, ritonavir-boosted lopinavir, and interferon-beta1a—should be evaluated in an international, adaptive, open-label, randomized clinical trial and compared with SoC in the treatment of hospitalized patients with SARS-CoV-2 infection. That led to the WHO Solidarity trial.

The HCQ and lopinavir groups of this trial were ended early because of reported lack of effect based on emerging external evidence from the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial, as well as internal evidence from interim analyses. In October, meanwhile, the WHO Solidarity trial reported that none of the repurposed drugs evaluated showed any significant effect on in-hospital mortality and did not reduce the need for mechanical ventilation. Those results were especially notable for remdesivir because they were contrary to the ACTT (Adaptive COVID-19 Treatment Trial), which determined that remdesivir significantly reduced time to recovery and discharge from the hospital, especially in patients not on mechanical ventilation.

An unanswered question was whether remdesivir could affect the clinical course in patients with mild or moderate disease, where viral replication appears to be the key driver, versus severe disease, where inflammation appears to play a larger role. That lead to the latest add-on study.

Researchers point out that overall mortality in NOR-Solidarity was lower than in the WHO-Solidarity trial, suggesting that could be due to early lockdown policies in Norway during the initial phase of the pandemic, reducing pressure on hospitals and healthcare systems.

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