Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection : a double-blind, placebo-controlled, randomised clinical trial
Alemany, Andrea (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Millat-Martinez, Pere (Hospital Clínic i Provincial de Barcelona)
Corbacho-Monné, Marc (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Suñer, Clara (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Galván-Casas, Cristina (Hospital Universitario de Móstoles (Madrid))
Carrera, Caty (Institut Català de la Salut)
Ouchi, Dan (Universitat Autònoma de Barcelona)
Prat, Núria (Institut Català de la Salut)
Ara del Rey, Jordi (Institut Català de la Salut)
Nadal, Nuria (Institut Català de la Salut)
Riel, Ricard (Institut Català de la Salut)
Funollet, Blanca (Institut Català de la Salut)
Ojeda-Ciurana, Carmen (Institut Català de la Salut)
Balague, Lluis Esteve (Institut Català de la Salut)
Salvador-González, Betlem (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Forcada Arcarons, Anna (Institut Català de la Salut)
Vidal-Alaball, Josep (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Del Cura-González, María Isabel (Red de Investigación en Cronicidad, Atención Primaria y Prevención y Promoción de la Salud)
Barrientos, Ricardo Rodríguez (Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud)
Ramos, Rafel (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Bou, Alberto Alum (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Mondou, Elsa (Grifols (Barcelona, Catalunya))
Torres, Mireia (Grifols (Barcelona, Catalunya))
Campins, Neus (Grifols (Barcelona, Catalunya))
Sanz, Ana (Grifols (Barcelona, Catalunya))
Tang, Yonggiang (Grifols (Barcelona, Catalunya))
Rodriguez-Arias, Miquel Àngel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Bassat, Quique (Hospital Clínic i Provincial de Barcelona)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Mitjà, Oriol (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)

Date:	2023
Abstract:	Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. registry: . 461 individuals (mean age 39. 6 years [SD 12. 8]) were randomized and received the intervention within a mean of 3. 1 (SD 1. 27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59. 9% (91/152) of participants receiving 1 g C19-IG20%, 64. 7% (99/153) receiving 2 g, and 63. 5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3. 6%; 95% CI -14. 6% to 7. 3%, p = 0. 53; 2 g C19-IG20% vs placebo, 1. 1%; −9. 6% to 11. 9%, p = 0. 85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. .
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Antibody therapies ; Asymptomatic individuals ; COVID-19 ; Hyperimmune immunoglobulin ; Outpatients ; SARS-CoV-2
Published in:	EClinicalMedicine, Vol. 57 (march 2023) , ISSN 2589-5370

DOI: 10.1016/j.eclinm.2023.101898
PMID: 36936402

13 p, 653.0 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Articles > Research articles
Articles > Published articles