Outpatient treatment with concomitant vaccine-boosted convalescent plasma for patients with immunosuppression and COVID-19
ABSTRACT Although severe coronavirus disease 2019 (COVID-19) and hospitalization associated with COVID-19 are generally preventable among healthy vaccine recipients, patients with immunosuppression have poor immunogenic responses to COVID-19 vaccines and remain at high risk of infection with SARS-CoV-2 and hospitalization. Additionally, monoclonal antibody therapy is limited by the emergence of novel SARS-CoV-2 variants that have serially escaped neutralization. In this context, there is interest in understanding the clinical benefit associated with COVID-19 convalescent plasma collected from persons who have been both naturally infected with SARS-CoV-2 and vaccinated against SARS-CoV-2 (“vax-plasma”). Thus, we report the clinical outcome of 386 immunocompromised outpatients who were diagnosed with COVID-19 and who received contemporary COVID-19 specific therapeutics (standard of care group) and a subgroup who also received concomitant treatment with very high titer COVID-19 convalescent plasma (vax-plasma group) with a specific focus on hospitalization rates. The overall hospitalization rate was 2.2% (5 of 225 patients) in the vax-plasma group and 6.2% (10 of 161 patients) in the standard of care group, which corresponded to a relative risk reduction of 65% (P=0.046). Evidence of efficacy in nonvaccinated patients cannot be inferred from these data because 94% (361 of 386 patients) of patients were vaccinated. In vaccinated patients with immunosuppression and COVID-19, the addition of vax-plasma or very high titer COVID-19 convalescent plasma to COVID-19 specific therapies reduced the risk of disease progression leading to hospitalization.IMPORTANCE As SARS-CoV-2 evolves, new variants of concern (VOCs) have emerged which evade available anti-spike monoclonal antibodies, particularly among immunosuppressed patients. However, high-titer COVID-19 convalescent plasma continues to be effective against VOCs because of its broad-spectrum immunomodulatory properties. Thus, we report clinical outcomes of 386 immunocompromised outpatients who were treated with COVID-19 specific therapeutics and a subgroup also treated with vaccine-boosted convalescent plasma. We found that administration of vaccine-boosted convalescent plasma was associated with a significantly decreased incidence of hospitalization among immunocompromised COVID-19 outpatients. Our data add to the contemporary data providing evidence to support the clinical utility of high-titer convalescent plasma as antibody replacement therapy in immunocompromised patients..
Medienart: |
Preprint |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
bioRxiv.org - (2024) vom: 23. Apr. Zur Gesamtaufnahme - year:2024 |
---|
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Ripoll, Juan G. [VerfasserIn] |
---|
Links: |
---|
Themen: |
---|
doi: |
10.1101/2023.08.29.23293790 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
XBI040702677 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | XBI040702677 | ||
003 | DE-627 | ||
005 | 20240424105325.0 | ||
007 | cr uuu---uuuuu | ||
008 | 230901s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1101/2023.08.29.23293790 |2 doi | |
035 | |a (DE-627)XBI040702677 | ||
035 | |a (biorXiv)10.1101/2023.08.29.23293790 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Ripoll, Juan G. |e verfasserin |0 (orcid)0000-0003-4908-9774 |4 aut | |
245 | 1 | 0 | |a Outpatient treatment with concomitant vaccine-boosted convalescent plasma for patients with immunosuppression and COVID-19 |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
520 | |a ABSTRACT Although severe coronavirus disease 2019 (COVID-19) and hospitalization associated with COVID-19 are generally preventable among healthy vaccine recipients, patients with immunosuppression have poor immunogenic responses to COVID-19 vaccines and remain at high risk of infection with SARS-CoV-2 and hospitalization. Additionally, monoclonal antibody therapy is limited by the emergence of novel SARS-CoV-2 variants that have serially escaped neutralization. In this context, there is interest in understanding the clinical benefit associated with COVID-19 convalescent plasma collected from persons who have been both naturally infected with SARS-CoV-2 and vaccinated against SARS-CoV-2 (“vax-plasma”). Thus, we report the clinical outcome of 386 immunocompromised outpatients who were diagnosed with COVID-19 and who received contemporary COVID-19 specific therapeutics (standard of care group) and a subgroup who also received concomitant treatment with very high titer COVID-19 convalescent plasma (vax-plasma group) with a specific focus on hospitalization rates. The overall hospitalization rate was 2.2% (5 of 225 patients) in the vax-plasma group and 6.2% (10 of 161 patients) in the standard of care group, which corresponded to a relative risk reduction of 65% (P=0.046). Evidence of efficacy in nonvaccinated patients cannot be inferred from these data because 94% (361 of 386 patients) of patients were vaccinated. In vaccinated patients with immunosuppression and COVID-19, the addition of vax-plasma or very high titer COVID-19 convalescent plasma to COVID-19 specific therapies reduced the risk of disease progression leading to hospitalization.IMPORTANCE As SARS-CoV-2 evolves, new variants of concern (VOCs) have emerged which evade available anti-spike monoclonal antibodies, particularly among immunosuppressed patients. However, high-titer COVID-19 convalescent plasma continues to be effective against VOCs because of its broad-spectrum immunomodulatory properties. Thus, we report clinical outcomes of 386 immunocompromised outpatients who were treated with COVID-19 specific therapeutics and a subgroup also treated with vaccine-boosted convalescent plasma. We found that administration of vaccine-boosted convalescent plasma was associated with a significantly decreased incidence of hospitalization among immunocompromised COVID-19 outpatients. Our data add to the contemporary data providing evidence to support the clinical utility of high-titer convalescent plasma as antibody replacement therapy in immunocompromised patients. | ||
650 | 4 | |a Biology |7 (dpeaa)DE-84 | |
650 | 4 | |a 570 |7 (dpeaa)DE-84 | |
700 | 1 | |a Tulledge-Scheitel, Sidna M. |e verfasserin |4 aut | |
700 | 1 | |a Stephenson, Anthony A. |e verfasserin |4 aut | |
700 | 1 | |a Ford, Shane |e verfasserin |0 (orcid)0000-0003-2776-9023 |4 aut | |
700 | 1 | |a Pike, Marsha L. |e verfasserin |4 aut | |
700 | 1 | |a Gorman, Ellen K. |e verfasserin |0 (orcid)0000-0003-2989-547X |4 aut | |
700 | 1 | |a Hanson, Sara N. |e verfasserin |4 aut | |
700 | 1 | |a Juskewitch, Justin E. |e verfasserin |0 (orcid)0000-0002-7868-2852 |4 aut | |
700 | 1 | |a Miller, Alex J. |e verfasserin |0 (orcid)0009-0006-2814-5561 |4 aut | |
700 | 1 | |a Zaremba, Solomiia |e verfasserin |0 (orcid)0009-0006-3030-7232 |4 aut | |
700 | 1 | |a Ovrom, Erik A. |e verfasserin |0 (orcid)0000-0002-5661-0698 |4 aut | |
700 | 1 | |a Razonable, Raymund R. |e verfasserin |0 (orcid)0000-0001-5248-0227 |4 aut | |
700 | 1 | |a Ganesh, Ravindra |e verfasserin |0 (orcid)0000-0002-6877-1712 |4 aut | |
700 | 1 | |a Hurt, Ryan T. |e verfasserin |4 aut | |
700 | 1 | |a Fischer, Erin N. |e verfasserin |4 aut | |
700 | 1 | |a Derr, Amber N. |e verfasserin |4 aut | |
700 | 1 | |a Eberle, Michele R. |e verfasserin |4 aut | |
700 | 1 | |a Larsen, Jennifer J. |e verfasserin |4 aut | |
700 | 1 | |a Carney, Christina M. |e verfasserin |4 aut | |
700 | 1 | |a Theel, Elitza S. |e verfasserin |0 (orcid)0000-0002-6886-2294 |4 aut | |
700 | 1 | |a Parikh, Sameer A. |e verfasserin |0 (orcid)0000-0002-3221-7314 |4 aut | |
700 | 1 | |a Kay, Neil E. |e verfasserin |0 (orcid)0000-0002-5951-5055 |4 aut | |
700 | 1 | |a Joyner, Michael J. |e verfasserin |0 (orcid)0000-0002-7135-7643 |4 aut | |
700 | 1 | |a Senefeld, Jonathon W. |e verfasserin |0 (orcid)0000-0001-8116-3538 |4 aut | |
773 | 0 | 8 | |i Enthalten in |t bioRxiv.org |g (2024) vom: 23. Apr. |
773 | 1 | 8 | |g year:2024 |g day:23 |g month:04 |
856 | 4 | 0 | |u https://doi.org/10.1128/mbio.00400-24 |x 0 |z lizenzpflichtig |3 Volltext |
856 | 4 | 0 | |u http://dx.doi.org/10.1101/2023.08.29.23293790 |x 0 |z kostenfrei |3 Volltext |
912 | |a GBV_XBI | ||
951 | |a AR | ||
952 | |j 2024 |b 23 |c 04 |