Association of subcutaneous or intravenous route of administration of casirivimab and imdevimab monoclonal antibodies with clinical outcomes in COVID-19

SciScore for 10.1101/2021.11.30.21266756: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Ethics	IRB: (Project ID 3629) and University of Pittsburgh Institutional Review Board (STUDY21100151)
Sex as a biological variable	Starting on September 28, 2021, patients aged 65 years or older with loss of two or more activities of daily living, pregnant patients, and/or patients with immunocompromised conditions were given priority for mAb treatment appointment scheduling.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.

Table 2: Resources

Antibodies
Sentences	Resources
This was a prospective cohort study of patients within the OPtimizing Treatment and Impact of Monoclonal antIbodieS Through Evaluation for COVID-19 embedded learning platform (OPTIMISE-C19, NCT04790786).	NCT04790786 suggested: None
Software and Algorithms
Sentences	Resources
Methods and results are reported in accordance with The REporting of studies Conducted using Observational Routinely-Collected health Data (RECORD) statement (eTable 1).16	RECORD suggested: (RECORD, RRID:SCR_009097)

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Results 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).

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Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

By avoiding limitations associated with intravenous administration, subcutaneous mAb treatment and post-exposure prophylaxis outpatient treatment location sites can potentially reach disadvantaged neighborhoods and low middle-income countries more readily. Our study has limitations. First, nontreated controls were matched by EUA-eligible risk factors only and we were unable to determine symptom severity (whether symptomatic or asymptomatic) in these patients. Thus, many nontreated patients may have been asymptomatic and thereby at low risk of hospitalization, which would tend to bias results against mAb treatment. Second, although adjusted for statistically, more patients in the subcutaneous group were fully vaccinated compared to the intravenous group at all sites, which may also lower risk of hospitalization and death. However, “fully vaccinated” on the referral form meant receipt of two doses of an mRNA vaccine or one dose of an adenovirus vaccine—further details on time from last dose to mAb referral, type of vaccine, or whether or not a third primary series dose had been administered to immunocompromised patients was unknown and therefore fully vaccinated cannot be interpreted as fully protected. This difference was also mitigated when the analysis was restricted to patients treated at same sites. Finally, the mean time from symptom onset to mAb treatment in our study was 6 days. While these therapies work best earliest in disease course, administering treatment faster i...

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Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

Identifier	Status	Title
NCT04790786	Recruiting	UPMC OPTIMISE-C19 Trial, a COVID-19 Study

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Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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Results from JetFighter: We did not find any issues relating to colormaps.

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Results from rtransparent:

• Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
• Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
• Thank you for including a protocol registration statement.

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Results from scite Reference Check: We found no unreliable references.

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