The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
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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.
Treatment with remdesivir was associated with a shorter time to recovery in patients hospitalized with coronavirus disease 2019 (COVID-19), according to peer-reviewed data published in the New England Journal of Medicine.