Findings showed that the trial did not meet statistical significance on the primary endpoint.
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The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
The study, which was fully remote and contactless, aimed to evaluate whether early treatment with fluvoxamine reduced the likelihood of clinical deterioration and disease severity in patients with mild COVID-19 illness.
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
The ACTT-2 study began on May 8 and included more than 1000 patients.
The placebo-controlled ACTT 3 trial will evaluate the efficacy and safety of remdesivir in combination with interferon beta-1a in more than 1000 hospitalized COVID-19 patients.
The patient, a 74-year-old female, presented to the ER after experiencing a low grade fever, cough, and shortness of breath for 2 days.
Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, appears to reduce respiratory distress as well as the hyperinflammatory immune response associated with coronavirus disease 2019.