Transplant recipients or individuals with malignancy present indeed an increased susceptibility to infections associated with a higher risk for progression to severe COVID-19 and a lower response to vaccination (23C25)

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Transplant recipients or individuals with malignancy present indeed an increased susceptibility to infections associated with a higher risk for progression to severe COVID-19 and a lower response to vaccination (23C25). individuals received either XAV-19 (N = 140) or placebo (N = Mouse monoclonal to CD22.K22 reacts with CD22, a 140 kDa B-cell specific molecule, expressed in the cytoplasm of all B lymphocytes and on the cell surface of only mature B cells. CD22 antigen is present in the most B-cell leukemias and lymphomas but not T-cell leukemias. In contrast with CD10, CD19 and CD20 antigen, CD22 antigen is still present on lymphoplasmacytoid cells but is dininished on the fully mature plasma cells. CD22 is an adhesion molecule and plays a role in B cell activation as a signaling molecule 139). A sluggish enrollment and a low rate of events pressured the termination of the premature trial. XAV-19 was well tolerated. Underpowered statistics did not allow the detection of any difference in the primary endpoint between the two organizations or in stratified organizations. Interestingly, analysis of the time to improvement (secondary endpoint) showed that XAV-19 significantly accelerated the recovery for individuals having a WHO score of 2 or 3 3 (median at 7 days vs. 14 days, p = 0.0159), and even more for individuals having a WHO score of 2 (4 days vs. 14 days, p = 0.0003). The neutralizing activity against Omicron and BA.2, BA.2.12.1, BA.4/5, and BQ.1.1 subvariants was shown. Conversation With this randomized placebo- controlled trial with premature termination, reduction of aggravation by XAV-19 at day time 8 in individuals with COVID-19 was not detectable. However, a significant reduction of the time to improvement for individuals not requiring oxygen was observed. XAV-19 managed a neutralizing activity against SARS-CoV-2 variants. Completely, these data support a possible therapeutic interest for individuals with slight to moderate COVID-19 requiring anti-SARS-CoV-2 neutralizing antibodies. Clinical Trial Sign up: https://clinicaltrials.gov/, identifier Eucalyptol NCT04928430; https://www.clinicaltrialsregister.eu/about.html (EudraCT), identifier 2020-005979-12. Keywords: COVID-19, medical trial, (glyco-humanized) polyclonal antibody, XAV-19, SARS-CoV-2 variants Highlights With this phase II/III randomized placebo-controlled medical trial including 279 individuals hospitalized or not, with slight to moderate COVID-19 (seven-point ordinal WHO score of 2, 3, or 4 at randomization), treatment with XAV-19 significantly accelerated recovery defined by a reduction of one point or more based on the seven-point ordinal level. The advantages of XAV-19 are its affordability and its activity against SARS-CoV-2 variants. Succeeding tests should confirm the restorative interest of XAV-19 for high-risk individuals with slight to moderate COVID-19. Intro Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), mass vaccination campaigns possess dramatically reduced the effect of the pandemic and the number of deaths. Prophylactic or restorative drugs such as antibodies, small molecules, or natural diet compounds are essential matches to vaccines (1C4). They may be particularly needed for Eucalyptol immunocompromised individuals or people who do not respond to the vaccination (5, 6). Several neutralizing monoclonal antibodies (mAbs) have been developed against SARS-CoV-2. Most of them were raised against the original Wuhan-type virus and see their neutralization potential abrogated or reduced against variants. Moreover, mAbs may favor the emergence of SARS-CoV-2-resistant variants in immunocompromised individuals (7). Approved anti-SARS-CoV-2 mAbs are no longer recommended since the end of 2022 because they are unlikely to be effective against growing strains of SARS-CoV-2 (8C10). Passive immunotherapy with convalescent COVID-19 plasma has also been investigated, although many questions remain concerning the medical efficiency of this strategy and its large-scale feasibility, i.e., donor selection, batch-to-batch reproducibility, or security issues (11C13). Owing to their potential to bind multiple target epitopes and maintain their neutralizing activity despite mutations, polyclonal antibodies (pAbs) of animal source represent a encouraging approach against COVID-19 (14, 15). Batch-to-batch reproducibility and viral security are critical points in pAb production. Hyperimmunization of certified and selected animals guarantees large quantities of high-titer and controlled pAb (15), and the purification process ensures less than one viral particle per 6 million doses (16). Therefore, pAbs against SARS-CoV-2 are becoming tested in medical tests (13, 17, 18). XAV-19 is definitely a swine Eucalyptol glyco-humanized polyclonal antibody (GH-pAb) issued from our technological platform as previously explained elsewhere (15, 16). XAV-19 is definitely directed against the Wuhan-type SARS-CoV-2 receptor-binding website (RBD). Thanks to the removal of xeno-antigens, XAV-19 is likely to prevent post-infusion serum sickness and allergies (19, 20). XAV-19 broadly neutralizes variants Eucalyptol and avoids selection of variants (15); it has been introduced in clinics since 2020. No hypersensitivity or.