Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19
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SciScore for 10.1101/2021.11.10.21265889: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization Subjects: Eligible subjects were uninfected adult volunteers, aged 18–90 years, who were healthy or had chronic but stable medical conditions, without signs/symptoms suggestive of COVID-19, and who were confirmed to be SARS-CoV-2 negative by central lab reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab ≤72 hours of randomization. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Secondary endpoints included: the proportion of subjects with treatment-emergent AEs (TEAEs), the proportion of subjects who achieved or exceeded the target concentration of … SciScore for 10.1101/2021.11.10.21265889: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization Subjects: Eligible subjects were uninfected adult volunteers, aged 18–90 years, who were healthy or had chronic but stable medical conditions, without signs/symptoms suggestive of COVID-19, and who were confirmed to be SARS-CoV-2 negative by central lab reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab ≤72 hours of randomization. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Secondary endpoints included: the proportion of subjects with treatment-emergent AEs (TEAEs), the proportion of subjects who achieved or exceeded the target concentration of REGEN-COV in serum (20 µg/mL) at the end of each 4-week dosing interval, and immunogenicity (measured by anti-drug antibodies [ADAs]) to REGEN-COV. anti-drugsuggested: NoneExploratory efficacy endpoints assessed the incidence and severity of symptomatic SARS-CoV-2 infection (ie, COVID-19) during the treatment and follow-up periods and the proportion of baseline anti-SARS-CoV-2 seronegative subjects who converted to seropositive for SARS-COV-2 anti-nucleocapsid IgG antibodies post-baseline; seroconversion from negative to positive for SARS-COV-2 anti-nucleocapsid IgG antibodies was considered indicative of an incident SARS-CoV-2 infection. anti-SARS-CoV-2suggested: Noneanti-nucleocapsid IgGsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A potential limitation of this study was that regular RT-PCR testing was not performed in all participants who presented with a clinical syndrome compatible with COVID-19. However, when only considering laboratory confirmed SARS-CoV-2 infection, REGEN-COV showed a 100% RRR in the development of COVID-19. The discrepancy could imply that these subjects had illnesses that were not due to SARS-CoV-2, or that sample collection was not close enough to symptom onset. An additional limitation of this study is that it was conducted before the emergence of several SARS-CoV-2 variants. However, extensive non-clinical testing has demonstrated that REGEN-COV retains its neutralization capacity against all clinically relevant viral variants tested to date, including beta, gamma, epsilon, and delta variants.10,13 Although it should not be deemed an appropriate substitute for vaccination in immunocompetent individuals, the efficacy and safety profile of REGEN-COV demonstrated in this study strongly support that REGEN-COV should be used for chronic prevention of COVID-19 in individuals not expected to mount a sufficient immune response to vaccination.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04519437 Active, not recruiting Study Assessing the Safety, Tolerability, Pharmacokinetics, … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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