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Article: Effectiveness of Different Antimicrobial Strategies for Staphylococcal Prosthetic Joint Infection: Results From a Large Prospective Registry-Based Cohort Study.

Scheper, Henk / van der Wal, Robert J P / Mahdad, Rachid / Keizer, Stefan / Delfos, Nathalie M / van der Lugt, Joris C T / Veldkamp, Karin Ellen / Nolte, Peter A / Leendertse, Masja / Gelinck, Luc B S / Mollema, Femke P N / Schippers, Emile F / Wattel-Louis, Hanke G / Visser, Leo G / Nelissen, Rob G H H / de Boer, Mark G J

Open forum infectious diseases

2022 Volume 9, Issue 10, Page(s) ofac474

Abstract: Background: Treatment of staphylococcal prosthetic joint infection (PJI) usually consists of surgical debridement and prolonged rifampicin combination therapy. Tailored antimicrobial treatment alternatives are needed due to frequent side effects and ... ...

Abstract	Background: Treatment of staphylococcal prosthetic joint infection (PJI) usually consists of surgical debridement and prolonged rifampicin combination therapy. Tailored antimicrobial treatment alternatives are needed due to frequent side effects and drug-drug interactions with rifampicin combination therapy. We aimed to assess the effectiveness of several alternative antibiotic strategies in patients with staphylococcal PJI. Methods: In this prospective, multicenter registry-based study, all consecutive patients with a staphylococcal PJI, treated with debridement, antibiotics and implant retention (DAIR) or 1-stage revision surgery between January 1, 2015 and November 3, 2020, were included. Patients were treated with a long-term rifampicin combination strategy (in 2 centers) or a short-term rifampicin combination strategy (in 3 centers). Antimicrobial treatment strategies in these centers were defined before the start of the registry. Patients were stratified in different groups, depending on the used antimicrobial strategy. Cox proportional hazards models were used to compare outcome between the groups. Results: Two hundred patients were included and stratified in 1 long-term rifampicin group (traditional rifampicin combination therapy) or 1 of 3 short-term rifampicin groups (clindamycin or flucloxacillin or vancomycin monotherapy, including rifampicin for only 5 postoperative days). Adjusted hazard ratios (aHRs) for failure in patients treated with short-term rifampicin and either flucloxacillin or clindamycin were almost equal to patients treated with long-term rifampicin combination therapy (aHR = 1.21; 95% confidence interval, .34-4.40). Conclusions: A short-term rifampicin strategy with either clindamycin or flucloxacillin and only 5 days of rifampicin was found to be as effective as traditional long-term rifampicin combination therapy. A randomized controlled trial is needed to further address efficacy and safety of alternative treatment strategies for staphylococcal PJI.
Language	English
Publishing date	2022-09-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac474
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Article ; Online: Under-vaccinated groups in Europe and their beliefs, attitudes and reasons for non-vaccination; two systematic reviews.

Fournet, N / Mollema, L / Ruijs, W L / Harmsen, I A / Keck, F / Durand, J Y / Cunha, M P / Wamsiedel, M / Reis, R / French, J / Smit, E G / Kitching, A / van Steenbergen, J E

BMC public health

2018 Volume 18, Issue 1, Page(s) 196

Abstract: Background: Despite effective national immunisation programmes in Europe, some groups remain incompletely or un-vaccinated ('under-vaccinated'), with underserved minorities and certain religious/ideological groups repeatedly being involved in outbreaks ... ...

Abstract	Background: Despite effective national immunisation programmes in Europe, some groups remain incompletely or un-vaccinated ('under-vaccinated'), with underserved minorities and certain religious/ideological groups repeatedly being involved in outbreaks of vaccine preventable diseases (VPD). Gaining insight into factors regarding acceptance of vaccination of 'under-vaccinated groups' (UVGs) might give opportunities to communicate with them in a trusty and reliable manner that respects their belief system and that, maybe, increase vaccination uptake. We aimed to identify and describe UVGs in Europe and to describe beliefs, attitudes and reasons for non-vaccination in the identified UVGs. Methods: We defined a UVG as a group of persons who share the same beliefs and/or live in socially close-knit communities in Europe and who have/had historically low vaccination coverage and/or experienced outbreaks of VPDs since 1950. We searched MEDLINE, EMBASE and PsycINFO databases using specific search term combinations. For the first systematic review, studies that described a group in Europe with an outbreak or low vaccination coverage for a VPD were selected and for the second systematic review, studies that described possible factors that are associated with non-vaccination in these groups were selected. Results: We selected 48 articles out of 606 and 13 articles out of 406 from the first and second search, respectively. Five UVGs were identified in the literature: Orthodox Protestant communities, Anthroposophists, Roma, Irish Travellers, and Orthodox Jewish communities. The main reported factors regarding vaccination were perceived non-severity of traditional "childhood" diseases, fear of vaccine side-effects, and need for more information about for example risk of vaccination. Conclusions: Within each UVG identified, there are a variety of health beliefs and objections to vaccination. In addition, similar factors are shared by several of these groups. Communication strategies regarding these similar factors such as educating people about the risks associated with being vaccinated versus not being vaccinated, addressing their concerns, and countering vaccination myths present among members of a specific UVG through a trusted source, can establish a reliable relationship with these groups and increase their vaccination uptake. Furthermore, other interventions such as improving access to health care could certainly increase vaccination uptake in Roma and Irish travellers.
MeSH term(s)	Europe ; Health Knowledge, Attitudes, Practice ; Humans ; Treatment Refusal/psychology ; Vaccination/statistics & numerical data
Language	English
Publishing date	2018-01-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	2041338-5
ISSN	1471-2458 ; 1471-2458
ISSN (online)	1471-2458
ISSN	1471-2458
DOI	10.1186/s12889-018-5103-8
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Article ; Online: Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial)

N Roescher / JM Prins / JTM van der Meer / HI Bax / R Soetekouw / MGJ de Boer / LBS Gelinck / JJ Oosterheert / MA van Agtmael / M Berrevoets / DTP Buis / CH van Werkhoven / MJM Bonten / JE Bosmans / J Branger / S Douiyeb / E Jong / AJJ Lammers / E Sieswerda /

BMJ Open, Vol 13, Iss

protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment

2023 Volume 4

Abstract: Introduction A major knowledge gap in the treatment of complicated Staphylococcus aureus bacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of ... ...

Abstract	Introduction A major knowledge gap in the treatment of complicated Staphylococcus aureus bacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of hospital stay and costs. The objective of the SAFE trial is to evaluate whether 4 weeks of antibiotic therapy is non-inferior to 6 weeks in patients with complicated SAB.Methods and analysis The SAFE-trial is a multicentre, non-inferiority, open-label, parallel group, randomised controlled trial evaluating 4 versus 6 weeks of antibiotic therapy for complicated SAB. The study is performed in 15 university hospitals and general hospitals in the Netherlands. Eligible patients are adults with methicillin-susceptible SAB with evidence of deep-seated or metastatic infection and/or predictors of complicated SAB. Only patients with a satisfactory clinical response to initial antibiotic treatment are included. Patients with infected prosthetic material or an undrained abscess of 5 cm or more at day 14 of adequate antibiotic treatment are excluded. Primary outcome is success of therapy after 180 days, a combined endpoint of survival without evidence of microbiologically confirmed disease relapse. Assuming a primary endpoint occurrence of 90% in the 6 weeks group, a non-inferiority margin of 7.5% is used. Enrolment of 396 patients in total is required to demonstrate non-inferiority of shorter antibiotic therapy with a power of 80%. Currently, 152 patients are enrolled in the study.Ethics and dissemination This is the first randomised controlled trial evaluating duration of antibiotic therapy for complicated SAB. Non-inferiority of 4 weeks of treatment would allow shortening of treatment duration in selected patients with complicated SAB. This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). Results of the study will be published in a peer-reviewed journal.Trial registration number ...
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Convalescent Plasma for COVID-19. A randomized clinical trial

Gharbharan, A. / Jordans, C. C. E. / GeurtsvanKessel, C. / den Hollander, J. G. / Karim, F. / Mollema, F. P. N. / Stalenhoef, J. E. / Dofferhoff, A. / Ludwig, I. / Koster, A. / Hassing, R.-J. / Bos, J. C. / van Pottelberge, G. R. / Vlasveld, I. N. / Ammerlaan, H. S. M. / Segarceanu, E. / Miedema, J. / van der Eerden, M. / Papageorgiou, G. /

te Broekhorst, P. / Swaneveld, F. H. / Katsikis, P. D. / Mueller, Y. / Okba, N. M. A. / Koopmans, M. P. G. / Haagmans, B. L. / Rokx, C. / Rijnders, B.

Abstract: ... to the 115 donors (1:160 vs 1:160, p=0.40). These observations caused concerns about the potential benefit ... the study was discontinued. No difference in mortality (p=0.95), hospital stay (p=0.68) or day-15 disease ... severity (p=0.58) was observed between plasma treated patients and patients on standard of care. Conclusion ...

Abstract	Background After recovery from COVID-19, most patients have anti-SARS-CoV-2 neutralizing antibodies. Their convalescent plasma could be an inexpensive and widely available treatment for COVID-19. Methods The Convalescent-plasma-for-COVID (ConCOVID) study was a randomized trial comparing convalescent plasma with standard of care therapy in patients hospitalized for COVID-19 in the Netherlands. Patients were randomized 1:1 and received 300ml of plasma with anti-SARS-CoV-2 neutralizing antibody titers of at least 1:80. The primary endpoint was day-60 mortality and key secondary endpoints were hospital stay and WHO 8-point disease severity scale improvement on day 15. Results The trial was halted prematurely after 86 patients were enrolled. Although symptomatic for only 10 days (IQR 6-15) at the time of inclusion, 53 of 66 patients tested had anti-SARS-CoV-2 antibodies at baseline. A SARS-CoV-2 plaque reduction neutralization test showed neutralizing antibodies in 44 of the 56 (79%) patients tested with median titers comparable to the 115 donors (1:160 vs 1:160, p=0.40). These observations caused concerns about the potential benefit of convalescent plasma in the study population and after discussion with the data safety monitoring board, the study was discontinued. No difference in mortality (p=0.95), hospital stay (p=0.68) or day-15 disease severity (p=0.58) was observed between plasma treated patients and patients on standard of care. Conclusion Most COVID-19 patients already have high neutralizing antibody titers at hospital admission. Screening for antibodies and prioritizing convalescent plasma to risk groups with recent symptom onset will be key to identify patients that may benefit from convalescent plasma. Clinicaltrials.gov: NCT04342182
Keywords	covid19
Publisher	MedRxiv; WHO
Document type	Article ; Online
DOI	10.1101/2020.07.01.20139857
Database	COVID19

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Article ; Online: Transmission of methicillin-resistant Staphylococcus aureus to household contacts.

Mollema, F P N / Richardus, J H / Behrendt, M / Vaessen, N / Lodder, W / Hendriks, W / Verbrugh, H A / Vos, M C

Journal of clinical microbiology

2009 Volume 48, Issue 1, Page(s) 202–207

Abstract: ... from an index person to household contacts occurred in nearly half of the cases (47%; n = 29). These 29 index ... persons together had 84 household contacts, of which two-thirds (67%; n = 56) became MRSA positive ...

Abstract	The frequency of and risk factors for methicillin-resistant Staphylococcus aureus (MRSA) transmission from a MRSA index person to household contacts were assessed in this prospective study. Between January 2005 and December 2007, 62 newly diagnosed MRSA index persons (46 patients and 16 health care workers) and their 160 household contacts were included in the study analysis. Transmission of MRSA from an index person to household contacts occurred in nearly half of the cases (47%; n = 29). These 29 index persons together had 84 household contacts, of which two-thirds (67%; n = 56) became MRSA positive. Prolonged exposure time to MRSA at home was a significant risk factor for MRSA transmission to household contacts. In addition, MRSA colonization at least in the throat, younger age, and eczema in index persons were significantly associated with MRSA transmission; the presence of wounds was negatively associated with MRSA transmission. Furthermore, an increased number of household contacts and being the partner of a MRSA index person were household-related risk factors for MRSA acquisition from the index person. No predominant pulsed-field gel electrophoresis (PFGE) type was observed to be transmitted more frequently than other PFGE types. To date, screening household contacts and providing MRSA eradication therapy to those found positive simultaneously with the index person is not included in the "search-and-destroy" policy. We suggest including both in MRSA prevention guidelines, as this may reduce further spread of MRSA.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Bacterial Typing Techniques ; Child ; Child, Preschool ; Cluster Analysis ; DNA Fingerprinting ; Electrophoresis, Gel, Pulsed-Field ; Family Characteristics ; Family Health ; Female ; Genotype ; Humans ; Infant ; Infant, Newborn ; Male ; Methicillin-Resistant Staphylococcus aureus/classification ; Methicillin-Resistant Staphylococcus aureus/genetics ; Methicillin-Resistant Staphylococcus aureus/isolation & purification ; Middle Aged ; Prospective Studies ; Risk Factors ; Staphylococcal Infections/epidemiology ; Staphylococcal Infections/microbiology ; Staphylococcal Infections/transmission ; Young Adult
Language	English
Publishing date	2009-11-18
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01499-09
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Article ; Online: Successful treatment for carriage of methicillin-resistant Staphylococcus aureus and importance of follow-up.

Mollema, F P N / Severin, J A / Nouwen, J L / Ott, A / Verbrugh, H A / Vos, M C

Antimicrobial agents and chemotherapy

2010 Volume 54, Issue 9, Page(s) 4020–4025

Abstract: With this prospective observational follow-up study of 165 methicillin-resistant Staphylococcus aureus (MRSA)-positive individuals (23 health care workers and 142 patients), we determined that our MRSA eradication therapy protocol results in a high ... ...

Abstract	With this prospective observational follow-up study of 165 methicillin-resistant Staphylococcus aureus (MRSA)-positive individuals (23 health care workers and 142 patients), we determined that our MRSA eradication therapy protocol results in a high success rate (81%). Five or more negative culture sets give a predictive value for MRSA eradication therapy success of >90%. Furthermore, MRSA colonization, at least in the throat, and the presence of wounds just before the start of MRSA eradication therapy are associated with MRSA eradication therapy failure.
MeSH term(s)	Adolescent ; Adult ; Anti-Bacterial Agents/therapeutic use ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Methicillin-Resistant Staphylococcus aureus/drug effects ; Methicillin-Resistant Staphylococcus aureus/pathogenicity ; Middle Aged ; Prospective Studies ; Staphylococcal Infections/drug therapy ; Staphylococcal Infections/microbiology ; Young Adult
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2010-06-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/AAC.01240-09
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Article ; Online: Vaccine confidence among parents: Large scale study in eighteen European countries.

Hadjipanayis, Adamos / van Esso, Diego / Del Torso, Stefano / Dornbusch, Hans Jürgen / Michailidou, Kyriaki / Minicuci, Nadia / Pancheva, Ruzha / Mujkic, Aida / Geitmann, Karin / Syridou, Garyfallia / Altorjai, Peter / Pasinato, Angela / Valiulis, Arunas / Soler, Paul / Cirstea, Olga / Illy, Károly / Mollema, Liesbeth / Mazur, Artur / Neves, Ana /

Zavrsnik, Jernej / Lapii, Fedir / Efstathiou, Elisavet / Kamphuis, Mascha / Grossman, Zachi

Vaccine

2019 Volume 38, Issue 6, Page(s) 1505–1512

Abstract: ... who consulted pediatricians (p < 0.05). Consultation with homeopathists was associated with the highest reported ... hesitancy (p < 0.05). Vaccine confidence was highest in Portugal and Cyprus, and lowest in Bulgaria and ...

Abstract	Background: Despite the fact that vaccines save 2-3 million lives worldwide every year, a percentage of children are not getting appropriately vaccinated, thus leading to disease outbreaks. One of the major reasons of low vaccine uptake in Europe is vaccine hesitancy, contributing to the recent measles outbreaks. Monitoring of vaccine hesitancy is valuable in early identification of vaccine concerns. Methods: We performed an eighteen country European survey on parents' attitudes and behaviors regarding their children's immunization. Parents having at least one child 1-4 years old were mostly recruited by primary care paediatricians to reply to a web-based questionnaire. The questionnaire was developed by the European Academy of Paediatrics Research in Ambulatory Setting Network steering committee, based on similar surveys. An individual level hesitancy score was constructed using the answers to 21 questions, and correlations of the score with socio-demographic characteristics and types of providers were explored. To assess inter country differences, a country level self -reported confidence was defined. Results: Fifty six percent and 24% of 5736 respondents defined themselves as "not at all hesitant", and "somewhat hesitant", respectively. Parents who consulted general practitioners were more hesitant than parents who consulted pediatricians (p < 0.05). Consultation with homeopathists was associated with the highest reported hesitancy (p < 0.05). Vaccine confidence was highest in Portugal and Cyprus, and lowest in Bulgaria and Poland. Conclusion: The majority of parents in Europe believe in the importance of childhood vaccination. However, significant lack of confidence was found in certain European countries, highlighting the need for continuous monitoring, awareness and response plans. The possible influence of different types of healthcare providers on parental decisions demonstrated for the first time in our survey, calls for further research. Monitoring and continuous medical education efforts aimed mostly at those professionals who might not be likely to recommend vaccination are suggested.
MeSH term(s)	Bulgaria ; Child, Preschool ; Cyprus ; Europe ; Health Knowledge, Attitudes, Practice ; Humans ; Infant ; Parents/psychology ; Poland ; Portugal ; Surveys and Questionnaires ; Vaccination/psychology ; Vaccines
Chemical Substances	Vaccines
Language	English
Publishing date	2019-12-14
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.11.068
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Article: Transmission of Methicillin-Resistant Staphylococcus aureus to Household Contacts

Mollema, F.P.N / Richardus, J.H / Behrendt, M / Vaessen, N / Lodder, W / Hendriks, W / Verbrugh, H.A / Vos, M.C

Journal of clinical microbiology JCM. 2010 Jan., v. 48, no. 1

2010

Abstract	The frequency of and risk factors for methicillin-resistant Staphylococcus aureus (MRSA) transmission from a MRSA index person to household contacts were assessed in this prospective study. Between January 2005 and December 2007, 62 newly diagnosed MRSA index persons (46 patients and 16 health care workers) and their 160 household contacts were included in the study analysis. Transmission of MRSA from an index person to household contacts occurred in nearly half of the cases (47%; n = 29). These 29 index persons together had 84 household contacts, of which two-thirds (67%; n = 56) became MRSA positive. Prolonged exposure time to MRSA at home was a significant risk factor for MRSA transmission to household contacts. In addition, MRSA colonization at least in the throat, younger age, and eczema in index persons were significantly associated with MRSA transmission; the presence of wounds was negatively associated with MRSA transmission. Furthermore, an increased number of household contacts and being the partner of a MRSA index person were household-related risk factors for MRSA acquisition from the index person. No predominant pulsed-field gel electrophoresis (PFGE) type was observed to be transmitted more frequently than other PFGE types. To date, screening household contacts and providing MRSA eradication therapy to those found positive simultaneously with the index person is not included in the "search-and-destroy" policy. We suggest including both in MRSA prevention guidelines, as this may reduce further spread of MRSA.
Language	English
Dates of publication	2010-01
Size	p. 202-207.
Publishing place	American Society for Microbiology
Document type	Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection.

Gharbharan, Arvind / Jordans, Carlijn C E / GeurtsvanKessel, Corine / den Hollander, Jan G / Karim, Faiz / Mollema, Femke P N / Stalenhoef-Schukken, Janneke E / Dofferhoff, Anthonius / Ludwig, Inge / Koster, Adrianus / Hassing, Robert-Jan / Bos, Jeannet C / van Pottelberge, Geert R / Vlasveld, Imro N / Ammerlaan, Heidi S M / van Leeuwen-Segarceanu, Elena M / Miedema, Jelle / van der Eerden, Menno / Schrama, Thijs J /

Papageorgiou, Grigorios / Te Boekhorst, Peter / Swaneveld, Francis H / Mueller, Yvonne M / Schreurs, Marco W J / van Kampen, Jeroen J A / Rockx, Barry / Okba, Nisreen M A / Katsikis, Peter D / Koopmans, Marion P G / Haagmans, Bart L / Rokx, Casper / Rijnders, Bart J A

Nature communications

2021 Volume 12, Issue 1, Page(s) 3189

Abstract: In a randomized clinical trial of 86 hospitalized COVID-19 patients comparing standard care to treatment with 300mL convalescent plasma containing high titers of neutralizing SARS-CoV-2 antibodies, no overall clinical benefit was observed. Using a ... ...

Abstract	In a randomized clinical trial of 86 hospitalized COVID-19 patients comparing standard care to treatment with 300mL convalescent plasma containing high titers of neutralizing SARS-CoV-2 antibodies, no overall clinical benefit was observed. Using a comprehensive translational approach, we unravel the virological and immunological responses following treatment to disentangle which COVID-19 patients may benefit and should be the focus of future studies. Convalescent plasma is safe, does not improve survival, has no effect on the disease course, nor does plasma enhance viral clearance in the respiratory tract, influence SARS-CoV-2 antibody development or serum proinflammatory cytokines levels. Here, we show that the vast majority of patients already had potent neutralizing SARS-CoV-2 antibodies at hospital admission and with comparable titers to carefully selected plasma donors. This resulted in the decision to terminate the trial prematurely. Treatment with convalescent plasma should be studied early in the disease course or at least preceding autologous humoral response development.
MeSH term(s)	Aged ; Antibodies, Neutralizing/blood ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; Blood Donors ; COVID-19/blood ; COVID-19/immunology ; COVID-19/therapy ; COVID-19/virology ; Cytokines/blood ; Disease Progression ; Female ; Hospitalization ; Humans ; Immunization, Passive ; Immunoglobulin G/blood ; Kaplan-Meier Estimate ; Male ; Middle Aged ; SARS-CoV-2/immunology ; Spike Glycoprotein, Coronavirus/immunology ; Treatment Outcome ; COVID-19 Serotherapy
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Cytokines ; Immunoglobulin G ; Spike Glycoprotein, Coronavirus
Language	English
Publishing date	2021-05-27
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-021-23469-2
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Article ; Online: Convalescent Plasma for COVID-19. A randomized clinical trial

Gharbharan, Arvind / Jordans, Carlijn C.E. / GeurtsvanKessel, Corine / den Hollander, Jan G. / Karim, Faiz / Mollema, Femke P.N. / Stalenhoef, Janneke E. / Dofferhoff, Anton / Ludwig, Inge / Koster, Ad / Hassing, Robert-Jan / Bos, Jeannet C. / van Pottelberge, Geert R. / Vlasveld, Imro N. / Ammerlaan, Heidi S.M. / Segarceanu, Elena / Miedema, Jelle / van der Eerden, Menno / Papageorgiou, Grigorios /

te Broekhorst, Peter / Swaneveld, Francis H. / Katsikis, Peter D. / Mueller, Yvonne / Okba, Nisreen M.A. / Koopmans, Marion P.G. / Haagmans, Bart L. / Rokx, Casper / Rijnders, Bart

medRxiv

Abstract	Background After recovery from COVID-19, most patients have anti-SARS-CoV-2 neutralizing antibodies. Their convalescent plasma could be an inexpensive and widely available treatment for COVID-19. Methods The Convalescent-plasma-for-COVID (ConCOVID) study was a randomized trial comparing convalescent plasma with standard of care therapy in patients hospitalized for COVID-19 in the Netherlands. Patients were randomized 1:1 and received 300ml of plasma with anti-SARS-CoV-2 neutralizing antibody titers of at least 1:80. The primary endpoint was day-60 mortality and key secondary endpoints were hospital stay and WHO 8-point disease severity scale improvement on day 15. Results The trial was halted prematurely after 86 patients were enrolled. Although symptomatic for only 10 days (IQR 6-15) at the time of inclusion, 53 of 66 patients tested had anti-SARS-CoV-2 antibodies at baseline. A SARS-CoV-2 plaque reduction neutralization test showed neutralizing antibodies in 44 of the 56 (79%) patients tested with median titers comparable to the 115 donors (1:160 vs 1:160, p=0.40). These observations caused concerns about the potential benefit of convalescent plasma in the study population and after discussion with the data safety monitoring board, the study was discontinued. No difference in mortality (p=0.95), hospital stay (p=0.68) or day-15 disease severity (p=0.58) was observed between plasma treated patients and patients on standard of care. Conclusion Most COVID-19 patients already have high neutralizing antibody titers at hospital admission. Screening for antibodies and prioritizing convalescent plasma to risk groups with recent symptom onset will be key to identify patients that may benefit from convalescent plasma. Clinicaltrials.gov: NCT04342182
Keywords	covid19
Language	English
Publishing date	2020-07-03
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2020.07.01.20139857
Database	COVID19

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