TY - JOUR
T1 - Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials
AU - ACTT-4 Study Group
AU - Siempos, Ilias i.
AU - Kalil, Andre c.
AU - Belhadi, Drifa
AU - Veiga, Viviane cordeiro
AU - Cavalcanti, Alexandre biasi
AU - Branch-Elliman, Westyn
AU - Papoutsi, Eleni
AU - Gkirgkiris, Konstantinos
AU - Xixi, Nikoleta a.
AU - Kotanidou, Anastasia
AU - Hermine, Olivier
AU - Porcher, Raphaël
AU - Mariette, Xavier
AU - Hermine, Olivier
AU - Mariette, Xavier
AU - Ravaud, Philippe
AU - Bureau, Serge
AU - Dougados, Maxime
AU - Resche-Rigon, Matthieu
AU - Tharaux, Pierre-Louis
AU - Tibi, Annick
AU - Hermine, Olivier
AU - Azoulay, Elie
AU - Bureau, Serge
AU - Cadranel, Jacques
AU - Dougados, Maxime
AU - Emmerich, Joseph
AU - Fartoukh, Muriel
AU - Guidet, Bertrand
AU - Humbert, Marc
AU - Lacombe, Karine
AU - Mahevas, Matthieu
AU - Mariette, Xavier
AU - Pene, Frédéric
AU - Porcher, Raphaël
AU - Pourchet-Martinez, Valerie
AU - Ravaud, Philippe
AU - Kramer, Laura
AU - Caro, A.
AU - Kline, Susan
AU - Noren, Brooke
AU - Kim, Hyun
AU - Bold, Tyler d.
AU - Walker, Robert
AU - Wang, Jing
AU - Billings, Joanne
AU - Kim, Hyun
AU - Wang, Jing
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/3/1
Y1 - 2024/3/1
N2 - Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of previously immunocompromised patients. We assessed the effect of immunomodulators on outcomes of immunocompromised patients hospitalized for COVID-19. Methods: The protocol was prospectively registered with PROSPERO (CRD42022335397). MEDLINE, Cochrane Central Register of Controlled Trials and references of relevant articles were searched up to 01-06-2022. Authors of potentially eligible randomized controlled trials were contacted to provide data on immunocompromised patients randomized to immunomodulators vs control (i.e., placebo or standard-of-care). Findings: Eleven randomized controlled trials involving 397 immunocompromised patients hospitalized for COVID-19 were included. Ten trials had low risk of bias. There was no difference between immunocompromised patients randomized to immunomodulators vs control regarding mortality [30/182 (16.5%) vs 41/215 (19.1%); RR 0.93, 95% CI 0.61–1.41; p = 0.74], secondary infections (RR 1.00, 95% CI 0.64–1.58; p = 0.99) and change in World Health Organization ordinal scale from baseline to day 15 (weighed mean difference 0.27, 95% CI -0.09–0.63; p = 0.15). In subgroup analyses including only patients with hematologic malignancy, only trials with low risk of bias, only trials administering IL-6 inhibitors, or only trials administering immunosuppressants, there was no difference between comparators regarding mortality. Interpretation: Immunomodulators, compared to control, were not associated with harmful or beneficial outcomes, including mortality, secondary infections, and change in ordinal scale, when administered to immunocompromised patients hospitalized for COVID-19. Funding: Hellenic Foundation for Research and Innovation.
AB - Background: Although immunomodulators have established benefit against the new coronavirus disease (COVID-19) in general, it is uncertain whether such agents improve outcomes without increasing the risk of secondary infections in the specific subgroup of previously immunocompromised patients. We assessed the effect of immunomodulators on outcomes of immunocompromised patients hospitalized for COVID-19. Methods: The protocol was prospectively registered with PROSPERO (CRD42022335397). MEDLINE, Cochrane Central Register of Controlled Trials and references of relevant articles were searched up to 01-06-2022. Authors of potentially eligible randomized controlled trials were contacted to provide data on immunocompromised patients randomized to immunomodulators vs control (i.e., placebo or standard-of-care). Findings: Eleven randomized controlled trials involving 397 immunocompromised patients hospitalized for COVID-19 were included. Ten trials had low risk of bias. There was no difference between immunocompromised patients randomized to immunomodulators vs control regarding mortality [30/182 (16.5%) vs 41/215 (19.1%); RR 0.93, 95% CI 0.61–1.41; p = 0.74], secondary infections (RR 1.00, 95% CI 0.64–1.58; p = 0.99) and change in World Health Organization ordinal scale from baseline to day 15 (weighed mean difference 0.27, 95% CI -0.09–0.63; p = 0.15). In subgroup analyses including only patients with hematologic malignancy, only trials with low risk of bias, only trials administering IL-6 inhibitors, or only trials administering immunosuppressants, there was no difference between comparators regarding mortality. Interpretation: Immunomodulators, compared to control, were not associated with harmful or beneficial outcomes, including mortality, secondary infections, and change in ordinal scale, when administered to immunocompromised patients hospitalized for COVID-19. Funding: Hellenic Foundation for Research and Innovation.
U2 - 10.1016/j.eclinm.2024.102472
DO - 10.1016/j.eclinm.2024.102472
M3 - Article
C2 - 38361992
SN - 2589-5370
VL - 69
SP - 102472
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102472
ER -
