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10.1056/NEJMoa2033130

http://scihub22266oqcxt.onion/10.1056/NEJMoa2033130
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33356051!7781100!33356051
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suck abstract from ncbi


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pmid33356051      N+Engl+J+Med 2021 ; 384 (10): 905-914
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  • A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 #MMPMID33356051
  • Lundgren JD; Grund B; Barkauskas CE; Holland TL; Gottlieb RL; Sandkovsky U; Brown SM; Knowlton KU; Self WH; Files DC; Jain MK; Benfield T; Bowdish ME; Leshnower BG; Baker JV; Jensen JU; Gardner EM; Ginde AA; Harris ES; Johansen IS; Markowitz N; Matthay MA; Ostergaard L; Chang CC; Davey VJ; Goodman A; Higgs ES; Murray DD; Murray TA; Paredes R; Parmar MKB; Phillips AN; Reilly C; Sharma S; Dewar RL; Teitelbaum M; Wentworth D; Cao H; Klekotka P; Babiker AG; Gelijns AC; Kan VL; Polizzotto MN; Thompson BT; Lane HC; Neaton JD
  • N Engl J Med 2021[Mar]; 384 (10): 905-914 PMID33356051show ga
  • BACKGROUND: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19. METHODS: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo. In addition, all the patients received high-quality supportive care as background therapy, including the antiviral drug remdesivir and, when indicated, supplemental oxygen and glucocorticoids. LY-CoV555 (at a dose of 7000 mg) or placebo was administered as a single intravenous infusion over a 1-hour period. The primary outcome was a sustained recovery during a 90-day period, as assessed in a time-to-event analysis. An interim futility assessment was performed on the basis of a seven-category ordinal scale for pulmonary function on day 5. RESULTS: On October 26, 2020, the data and safety monitoring board recommended stopping enrollment for futility after 314 patients (163 in the LY-CoV555 group and 151 in the placebo group) had undergone randomization and infusion. The median interval since the onset of symptoms was 7 days (interquartile range, 5 to 9). At day 5, a total of 81 patients (50%) in the LY-CoV555 group and 81 (54%) in the placebo group were in one of the two most favorable categories of the pulmonary outcome. Across the seven categories, the odds ratio of being in a more favorable category in the LY-CoV555 group than in the placebo group was 0.85 (95% confidence interval [CI], 0.56 to 1.29; P = 0.45). The percentage of patients with the primary safety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV555 group and the placebo group (19% and 14%, respectively; odds ratio, 1.56; 95% CI, 0.78 to 3.10; P = 0.20). The rate ratio for a sustained recovery was 1.06 (95% CI, 0.77 to 1.47). CONCLUSIONS: Monoclonal antibody LY-CoV555, when coadministered with remdesivir, did not demonstrate efficacy among hospitalized patients who had Covid-19 without end-organ failure. (Funded by Operation Warp Speed and others; TICO ClinicalTrials.gov number, NCT04501978.).
  • |*COVID-19 Drug Treatment[MESH]
  • |Adenosine Monophosphate/analogs & derivatives/therapeutic use[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Alanine/analogs & derivatives/therapeutic use[MESH]
  • |Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use[MESH]
  • |Antibodies, Neutralizing/adverse effects/*therapeutic use[MESH]
  • |Antiviral Agents/adverse effects/*therapeutic use[MESH]
  • |COVID-19/mortality[MESH]
  • |Double-Blind Method[MESH]
  • |Drug Therapy, Combination[MESH]
  • |Female[MESH]
  • |Glucocorticoids/therapeutic use[MESH]
  • |Hospitalization[MESH]
  • |Humans[MESH]
  • |Intention to Treat Analysis[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]


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