In the 28-day, 1,379 patient, Phase II/III, EPIC-HR trial (NCT04960202), where 0.72% of patients treated with the combination of nirmatrelvir and ritonavir were hospitalized with no deaths compared to 6.45% who were hospitalized or died with placebo in unvaccinated patients with mild-to-moderate COVID-19 at risk to progress to severe illness.
In the 28-day, 490 patient, Phase III, I-TECH trial (NCT04920942), treatment with ivermectin did not reduce the percentage of patients that progressed to severe COVID-19 in high-risk Malaysian outpatients with COVID-19.
Synairgen announced that in the 623 patient, 28-day, Phase III SPRINTER trial (NCT04732949), treatment with SNG001 did not decrease time to hospital discharge compared to placebo in hospitalized patients with COVID-19.
A CDC analysis found that mothers who complete a two-dose vaccination series with an mRNA COVID-19 vaccine resulted in vaccine effectiveness of 61% in their infants < 6 months old. Limited data showed vaccine effectiveness to be 32% if given during the first 20 weeks of pregnancy and 80% if given from 21 weeks to 2 weeks before delivery.
A review of medical records from an Israeli managed care database found that vaccine effectiveness with the Pfizer–BioNTech COVID-19 vaccine in patients who recovered from COVID-19 was 82% in patients 16 to 64 and 60% in patients 65 and older.
Sanofi and GSK announced that in the 21,046 patient, Phase III, VAT08 trial (NCT04904549), vaccination with two doses of their COVID-19 vaccine resulted in vaccine efficacy of 57.9% against any symptomatic COVID-19 disease, 75% efficacy against moderate or severe COVID-19 disease and 100% against severe COVID-19 disease and hospitalizations
GSK and Vir announced that in the 29-day, 754 patient, open-label, Phase III, COMET-TAIL trial (NCT04913675), intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration (2.7% vs 1.3%) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (12 years of age and older).
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