Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study
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Abstract
We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in coronavirus disease 2019 (COVID-19)-related moderate pneumonia. The objective was to evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia.
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SciScore for 10.1101/2021.04.15.21255549: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was reviewed and approved by the Ethics Committee OUEST VI (20.06.15.31306).
Consent: All patients provided written informed consent before the entry in the study.Sex as a biological variable , known allergy, hypersensitivity or intolerance to the study drug or to any of its components, life expectancy estimated to be less than 6 months patient under guardianship or trusteeship, pregnancy or lack of effective contraception in women of childbearing potential. Randomization Study design and participants: This is an ongoing multicenter, randomized, double-blind, placebo-controlled, phase IIa-III clinical trial involving hospitalized patients with COVID-19-related moderate … SciScore for 10.1101/2021.04.15.21255549: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study protocol was reviewed and approved by the Ethics Committee OUEST VI (20.06.15.31306).
Consent: All patients provided written informed consent before the entry in the study.Sex as a biological variable , known allergy, hypersensitivity or intolerance to the study drug or to any of its components, life expectancy estimated to be less than 6 months patient under guardianship or trusteeship, pregnancy or lack of effective contraception in women of childbearing potential. Randomization Study design and participants: This is an ongoing multicenter, randomized, double-blind, placebo-controlled, phase IIa-III clinical trial involving hospitalized patients with COVID-19-related moderate pneumonia requiring low-flow oxygen supplementation[10]. Blinding Following blinded analysis of the first cohort (0.5mg/kg at D1 and D5) and of the first two patients (one active and one placebo) of the second cohort (2mg/kg at D1 and D5), the remaining patients of the second cohort received a single infusion of 2 mg/kg of XAV-19 at day 1. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources This SOC included use of dexamethasone and other treatments per local practice and national guidelines at time of the study, which may include, not exclusively, antibiotics, antiviral treatment, immune therapies not based on antibodies administration and anticoagulants. antibiotics ,suggested: Noneanticoagulantssuggested: 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:An important limitation of this phase IIa portion of our trial is the small sample size, that did not allow to determine if XAV-19 was associated with improved outcomes. This question will be rigorously tested in the analysis of the phase III part of this ongoing trial. Even if the number of patients who received XAV-19 was low, there were no safety concerns. Second, higher doses of XAV-19 were not explored. However, the 2 mg/kg dose achieved sustained active concentrations. In conclusion, XAV-19 was well tolerated in patients admitted to hospital for COVID-related moderate pneumonia requiring low-flow oxygen supplementation. The pharmacokinetic results of a single infusion of 2 mg/kg suggest that this dose has the potential to successfully block viral diffusion in humans and supports the selection of this regimen for the ongoing multicentre randomized (1:1), double-blind, placebo-controlled phase III trial (ClinicalTrial.gov, NCT04453384) involving 400 patients.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04453384 Recruiting Study to Evaluate the Safety and Efficacy of XAV-19 in Patie… 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.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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