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Anti–Ebola Virus Antibody Levels in Convalescent Plasma and Viral Load After Plasma Infusion in Patients With Ebola Virus Disease

Brown, Jerry F ; Dye, John M ; Tozay, Sam ; [et al.]

Oxford University Press (OUP) ; 2018

In: The Journal of Infectious Diseases Vol. 218, No. 4 ( 2018-07-13), p. 555-562

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In: The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 218, No. 4 ( 2018-07-13), p. 555-562

Abstract: Enzyme-linked immunosorbent and microneutralization assays of 180 Ebola convalescent plasma specimens were highly concordant and predictive for detection of antibody by 50% plaque reduction neutralization test. Viral load decreased following infusion of antibody-containing plasma in 2 Ebola virus disease patients.

Type of Medium: Online Resource

ISSN: 0022-1899 , 1537-6613

URL: Article

DOI: 10.1093/infdis/jiy199

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XA 10000

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2018

detail.hit.zdb_id: 1473843-0

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878. Association between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death for Non-Hospitalized Adults with Mild-to-Moderate COVID-19

Giganti, Mark ; Chew, Kara W ; Eron, Joseph J ; [et al.]

Oxford University Press (OUP) ; 2022

In: Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)

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In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)

Abstract: Data are currently limited on the performance of SARS-CoV-2 RNA levels as predictors or surrogate markers for clinical outcomes in outpatients with mild-to-moderate COVID-19. Methods This exploratory analysis used data from 2205 non-hospitalized adults who enrolled between August 2020 and July 2021 and participated in placebo-controlled evaluations of two monoclonal antibody (mAb) agents (bamlanivimab [n=317] or amubarvimab/romlusevimab [n=837] ), and an open-label cohort of bamlanivimab recipients [n=1051] as part of the ACTIV-2/A5401 platform trial. SARS-CoV-2 RNA levels were measured in anterior nasal (AN) swabs and plasma at day 0 (pre-treatment) and AN at day 3. We fit regression models to estimate the association between RNA level or detection and subsequent hospitalization/death within 28 days of enrollment. Results One-hundred four participants (53/571 [9%] on placebo and 51/1634 [3%] on mAb) died or were hospitalized through day 28. Median AN RNA levels were lower at day 3 compared to day 0 in both placebo (2.5 vs 4.0 log10 copies/mL [cp/mL]) and mAb (2.3 vs 4.9) groups. For placebo recipients, higher Day 0 AN RNA was associated with an increasing risk of hospitalization/death, ranging from 3% to 16% for & lt; 2 and ≥ 6 log10 cp/mL, respectively. Although only 1% had quantifiable plasma SARS-CoV-2 RNA, there was a similar trend for day 0 plasma RNA: 5% hospitalizations/death for undetectable RNA, 16% for detectable but not quantifiable RNA, and 80% for ≥ 2 log10 cp/mL. Among 485 placebo recipients with days 0 and 3 AN RNA results, the risk of subsequent hospitalization/death was highest among those with ≥ 5.0 log10 cp/mL at both days [8/78; 10%] and lowest for those with unquantifiable levels at both days [0/124; 0%] . Higher AN RNA at day 3 (adjusted for day 0 RNA) was associated with subsequent hospitalization/death among placebo recipients (relative risk (RR): 1.4 per log10 cp/mL; 95%CI: 1.0, 2.1), but not mAb recipients (RR: 1.0; 95%CI: 0.7, 1.6). Conclusion These findings suggest that AN and plasma SARS-CoV-2 RNA levels are predictive of hospitalization/death in the natural history setting. However, different associations for mAb and placebo recipients raises concerns for using AN RNA as a surrogate for clinical outcomes in mAb trials. Disclosures Kara W. Chew, M.D., M.S., Merck Sharp & Dohme: Grant/Research Support|Pardes Bioscences: Advisor/Consultant Joseph J. Eron, MD, GSK: Advisor/Consultant|Merck: Advisor/Consultant Jonathan Z. Li, MD, MMSc, Abbvie: Advisor/Consultant|Merck: Grant/Research Support William A. Fischer, II, MD, Janssen: Adjudication Committee (Influenza)|Merck: Advisor/Consultant|Ridgeback Biopharmaceuticals: Research funding provided to the University of North Carolina|Roche: Advisor/Consultant|Syneos: Adjudication committee (Influenza) Paul Klekotka, MD, PhD, Eli Lilly: Employee|Eli Lilly: Stocks/Bonds David A. Margolis, MD MPH, Brii Biosciences: Stocks/Bonds David A. Wohl, M.D., Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Lilly: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Eric S. Daar, M.D., Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Merck: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Davey M. Smith, M.D., M.A.S., Arena Pharmaceuticals: Advisor/Consultant|Bayer Pharmaceuticals: Advisor/Consultant|Brio Clinical.: Advisor/Consultant|Fluxergy: Advisor/Consultant|Kiadis: Advisor/Consultant|Linear Therapies: Advisor/Consultant|Matrix BioMed: Advisor/Consultant|Model Medicines: Advisor/Consultant|Signant Health: Advisor/Consultant|VxBiosciences: Advisor/Consultant Judith S. Currier, M.D., MSc, Merck: Advisor/Consultant.

Type of Medium: Online Resource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofac492.071

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2022

detail.hit.zdb_id: 2757767-3

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One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial

Jilg, Nikolaus ; Chew, Kara W ; Giganti, Mark J ; [et al.]

Oxford University Press (OUP) ; 2023

In: Clinical Infectious Diseases Vol. 77, No. 7 ( 2023-10-05), p. 941-949

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In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 77, No. 7 ( 2023-10-05), p. 941-949

Abstract: Camostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of camostat in ACTIV-2/A5401, a phase 2/3 platform trial of therapeutics for COVID-19 in nonhospitalized adults. Methods We conducted a phase 2 study in adults with mild-to-moderate COVID-19 randomized to oral camostat for 7 days or a pooled placebo arm. Primary outcomes were time to improvement in COVID-19 symptoms through day 28, proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal swabs through day 14, and grade ≥3 treatment-emergent adverse events (TEAEs) through day 28. Results Of 216 participants (109 randomized to camostat, 107 to placebo) who initiated study intervention, 45% reported ≤5 days of symptoms at study entry and 26% met the protocol definition of higher risk of progression to severe COVID-19. Median age was 37 years. Median time to symptom improvement was 9 days in both arms (P = .99). There were no significant differences in the proportion of participants with SARS-CoV-2 RNA & lt;LLoQ on days 3, 7, and 14. Through day 28, 6 (5.6%) participants in the camostat arm and 5 (4.7%) in the placebo arm were hospitalized; 1 participant in the camostat arm subsequently died. Grade ≥3 TEAEs occurred in 10.1% of camostat versus 6.5% of placebo participants (P = .35). Conclusions In a phase 2 study of nonhospitalized adults with mild-to-moderate COVID-19, oral camostat did not accelerate viral clearance or time to symptom improvement, or reduce hospitalizations or deaths. Clinical Trials Registration. ClinicalTrials.gov identifier: NCT 04518410.

Type of Medium: Online Resource

ISSN: 1058-4838 , 1537-6591

URL: Article

DOI: 10.1093/cid/ciad342

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XA 10000

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2023

detail.hit.zdb_id: 2002229-3

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Simplification to Abacavir/Lamivudine + Atazanavir Maintains Viral Suppression and Improves Bone and Renal Biomarkers in ASSURE, a Randomized, Open Label, Non-Inferiority Trial

Wohl, David A. ; Bhatti, Laveeza ; Small, Catherine B. ; [et al.]

Public Library of Science (PLoS) ; 2014

In: PLoS ONE Vol. 9, No. 5 ( 2014-5-13), p. e96187-

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In: PLoS ONE, Public Library of Science (PLoS), Vol. 9, No. 5 ( 2014-5-13), p. e96187-

Type of Medium: Online Resource

ISSN: 1932-6203

URL: Article

DOI: 10.1371/journal.pone.0096187

DOI: 10.1371/journal.pone.0096187.g001

DOI: 10.1371/journal.pone.0096187.g002

DOI: 10.1371/journal.pone.0096187.g003

DOI: 10.1371/journal.pone.0096187.t001

DOI: 10.1371/journal.pone.0096187.t002

DOI: 10.1371/journal.pone.0096187.s001

DOI: 10.1371/journal.pone.0096187.s002

Language: English

Publisher: Public Library of Science (PLoS)

Publication Date: 2014

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Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial

Jagannathan, Prasanna ; Chew, Kara W. ; Giganti, Mark J. ; [et al.]

Elsevier BV ; 2023

In: eClinicalMedicine Vol. 65 ( 2023-11), p. 102250-

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In: eClinicalMedicine, Elsevier BV, Vol. 65 ( 2023-11), p. 102250-

Type of Medium: Online Resource

ISSN: 2589-5370

URL: Article

DOI: 10.1016/j.eclinm.2023.102250

Language: English

Publisher: Elsevier BV

Publication Date: 2023

detail.hit.zdb_id: 2946413-4

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The evolving SARS-CoV-2 epidemic in Africa: Insights from rapidly expanding genomic surveillance

Tegally, Houriiyah ; San, James E. ; Cotten, Matthew ; [et al.]

American Association for the Advancement of Science (AAAS) ; 2022

In: Science Vol. 378, No. 6615 ( 2022-10-07)

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In: Science, American Association for the Advancement of Science (AAAS), Vol. 378, No. 6615 ( 2022-10-07)

Abstract: Investment in Africa over the past year with regard to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sequencing has led to a massive increase in the number of sequences, which, to date, exceeds 100,000 sequences generated to track the pandemic on the continent. These sequences have profoundly affected how public health officials in Africa have navigated the COVID-19 pandemic. RATIONALE We demonstrate how the first 100,000 SARS-CoV-2 sequences from Africa have helped monitor the epidemic on the continent, how genomic surveillance expanded over the course of the pandemic, and how we adapted our sequencing methods to deal with an evolving virus. Finally, we also examine how viral lineages have spread across the continent in a phylogeographic framework to gain insights into the underlying temporal and spatial transmission dynamics for several variants of concern (VOCs). RESULTS Our results indicate that the number of countries in Africa that can sequence the virus within their own borders is growing and that this is coupled with a shorter turnaround time from the time of sampling to sequence submission. Ongoing evolution necessitated the continual updating of primer sets, and, as a result, eight primer sets were designed in tandem with viral evolution and used to ensure effective sequencing of the virus. The pandemic unfolded through multiple waves of infection that were each driven by distinct genetic lineages, with B.1-like ancestral strains associated with the first pandemic wave of infections in 2020. Successive waves on the continent were fueled by different VOCs, with Alpha and Beta cocirculating in distinct spatial patterns during the second wave and Delta and Omicron affecting the whole continent during the third and fourth waves, respectively. Phylogeographic reconstruction points toward distinct differences in viral importation and exportation patterns associated with the Alpha, Beta, Delta, and Omicron variants and subvariants, when considering both Africa versus the rest of the world and viral dissemination within the continent. Our epidemiological and phylogenetic inferences therefore underscore the heterogeneous nature of the pandemic on the continent and highlight key insights and challenges, for instance, recognizing the limitations of low testing proportions. We also highlight the early warning capacity that genomic surveillance in Africa has had for the rest of the world with the detection of new lineages and variants, the most recent being the characterization of various Omicron subvariants. CONCLUSION Sustained investment for diagnostics and genomic surveillance in Africa is needed as the virus continues to evolve. This is important not only to help combat SARS-CoV-2 on the continent but also because it can be used as a platform to help address the many emerging and reemerging infectious disease threats in Africa. In particular, capacity building for local sequencing within countries or within the continent should be prioritized because this is generally associated with shorter turnaround times, providing the most benefit to local public health authorities tasked with pandemic response and mitigation and allowing for the fastest reaction to localized outbreaks. These investments are crucial for pandemic preparedness and response and will serve the health of the continent well into the 21st century. Expanse of SARS-CoV-2 sequencing capacity in Africa. ( A ) African countries (shaded in gray) and institutions (red circles) with on-site sequencing facilities that are capable of producing SARS-CoV-2 whole genomes locally. ( B ) The number of SARS-CoV-2 genomes produced per country and the proportion of those genomes that were produced locally, regionally within Africa, or abroad. ( C ) Decreased turnaround time of sequencing output in Africa to an almost real-time release of genomic data.

Type of Medium: Online Resource

ISSN: 0036-8075 , 1095-9203

URL: Article

DOI: 10.1126/science.abq5358

RVK:

TA 1000

RVK:

WA 15000

Language: English

Publisher: American Association for the Advancement of Science (AAAS)

Publication Date: 2022

detail.hit.zdb_id: 128410-1

detail.hit.zdb_id: 2066996-3

detail.hit.zdb_id: 2060783-0

SSG: 11

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Current and Past Immunodeficiency Are Associated With Higher Hospitalization Rates Among Persons on Virologically Suppressive Antiretroviral Therapy for up to 11 Years

Davy-Mendez, Thibaut ; Napravnik, Sonia ; Eron, Joseph J ; [et al.]

Oxford University Press (OUP) ; 2021

In: The Journal of Infectious Diseases Vol. 224, No. 4 ( 2021-08-16), p. 657-666

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In: The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 224, No. 4 ( 2021-08-16), p. 657-666

Abstract: Persons with human immunodeficiency virus (PWH) with persistently low CD4 counts despite efficacious antiretroviral therapy could have higher hospitalization risk. Methods In 6 US and Canadian clinical cohorts, PWH with virologic suppression for ≥1 year in 2005–2015 were followed until virologic failure, loss to follow-up, death, or study end. Stratified by early (years 2–5) and long-term (years 6–11) suppression and lowest presuppression CD4 count & lt;200 and ≥200 cells/µL, Poisson regression models estimated hospitalization incidence rate ratios (aIRRs) comparing patients by time-updated CD4 count category, adjusted for cohort, age, gender, calendar year, suppression duration, and lowest presuppression CD4 count. Results The 6997 included patients (19 980 person-years) were 81% cisgender men and 40% white. Among patients with lowest presuppression CD4 count & lt;200 cells/μL (44%), patients with current CD4 count 200–350 vs & gt;500 cells/μL had aIRRs of 1.44 during early suppression (95% confidence interval [CI], 1.01–2.06), and 1.67 (95% CI, 1.03–2.72) during long-term suppression. Among patients with lowest presuppression CD4 count ≥200 (56%), patients with current CD4 351–500 vs & gt;500 cells/μL had an aIRR of 1.22 (95% CI, .93–1.60) during early suppression and 2.09 (95% CI, 1.18–3.70) during long-term suppression. Conclusions Virologically suppressed patients with lower CD4 counts experienced higher hospitalization rates and could potentially benefit from targeted clinical management strategies.

Type of Medium: Online Resource

ISSN: 0022-1899 , 1537-6613

URL: Article

DOI: 10.1093/infdis/jiaa786

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XA 10000

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2021

detail.hit.zdb_id: 1473843-0

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Hospitalization Rates and Causes Among Persons With HIV in the United States and Canada, 2005–2015

Davy-Mendez, Thibaut ; Napravnik, Sonia ; Hogan, Brenna C ; [et al.]

Oxford University Press (OUP) ; 2021

In: The Journal of Infectious Diseases Vol. 223, No. 12 ( 2021-06-15), p. 2113-2123

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In: The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 223, No. 12 ( 2021-06-15), p. 2113-2123

Abstract: To assess the possible impact of antiretroviral therapy improvements, aging, and comorbidities, we examined trends in all-cause and cause-specific hospitalization rates among persons with HIV (PWH) from 2005 to 2015. Methods In 6 clinical cohorts, we followed PWH in care (≥1 outpatient CD4 count or HIV load [VL] every 12 months) and categorized ICD codes of primary discharge diagnoses using modified Clinical Classifications Software. Poisson regression estimated hospitalization rate ratios for calendar time trends, adjusted for demographics, HIV risk factor, and annually updated age, CD4, and VL. Results Among 28 057 patients (125 724 person-years), from 2005 to 2015, the median CD4 increased from 389 to 580 cells/µL and virologic suppression from 55% to 85% of patients. Unadjusted all-cause hospitalization rates decreased from 22.3 per 100 person-years in 2005 (95% confidence interval [CI], 20.6–24.1) to 13.0 in 2015 (95% CI, 12.2–14.0). Unadjusted rates decreased for almost all diagnostic categories. Adjusted rates decreased for all-cause, cardiovascular, and AIDS-defining conditions, increased for non-AIDS–defining infection, and were stable for most other categories. Conclusions Among PWH with increasing CD4 counts and viral suppression, unadjusted hospitalization rates decreased for all-cause and most cause-specific hospitalizations, despite the potential effects of aging, comorbidities, and cumulative exposure to HIV and antiretrovirals.

Type of Medium: Online Resource

ISSN: 0022-1899 , 1537-6613

URL: Article

DOI: 10.1093/infdis/jiaa661

RVK:

XA 10000

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2021

detail.hit.zdb_id: 1473843-0

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Evaluation of a COVID-19 convalescent plasma program at a U.S. academic medical center

Root, Heather B. ; Gilleskie, Matt ; Lu, Chih-Huan ; [et al.]

Public Library of Science (PLoS) ; 2022

In: PLOS ONE Vol. 17, No. 12 ( 2022-12-8), p. e0277707-

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In: PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 12 ( 2022-12-8), p. e0277707-

Abstract: Amidst the therapeutic void at the onset of the COVID-19 pandemic, a critical mass of scientific and clinical interest coalesced around COVID-19 convalescent plasma (CCP). To date, the CCP literature has focused largely on safety and efficacy outcomes, but little on implementation outcomes or experience. Expert opinion suggests that if CCP has a role in COVID-19 treatment, it is early in the disease course, and it must deliver a sufficiently high titer of neutralizing antibodies (nAb). Missing in the literature are comprehensive evaluations of how local CCP programs were implemented as part of pandemic preparedness and response, including considerations of the core components and personnel required to meet demand with adequately qualified CCP in a timely and sustained manner. To address this gap, we conducted an evaluation of a local CCP program at a large U.S. academic medical center, the University of North Carolina Medical Center (UNCMC), and patterned our evaluation around the dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to systematically describe key implementation-relevant metrics. We aligned our evaluation with program goals of reaching the target population with severe or critical COVID-19, integrating into the structure of the hospital-wide pandemic response, adapting to shifting landscapes, and sustaining the program over time during a compassionate use expanded access program (EAP) era and a randomized controlled trial (RCT) era. During the EAP era, the UNCMC CCP program was associated with faster CCP infusion after admission compared with contemporaneous affiliate hospitals without a local program: median 29.6 hours (interquartile range, IQR: 21.2–48.1) for the UNCMC CCP program versus 47.6 hours (IQR 32.6–71.6) for affiliate hospitals; (P 〈 0.0001). Sixty-eight of 87 CCP recipients in the EAP (78.2%) received CCP containing the FDA recommended minimum nAb titer of ≥1:160. CCP delivery to hospitalized patients operated with equal efficiency regardless of receiving treatment via a RCT or a compassionate-use mechanism. It was found that in a highly resourced academic medical center, rapid implementation of a local CCP collection, treatment, and clinical trial program could be achieved through re-deployment of highly trained laboratory and clinical personnel. These data provide important pragmatic considerations critical for health systems considering the use of CCP as part of an integrated pandemic response.

Type of Medium: Online Resource

ISSN: 1932-6203

URL: Article

DOI: 10.1371/journal.pone.0277707

DOI: 10.1371/journal.pone.0277707.g001

DOI: 10.1371/journal.pone.0277707.g002

DOI: 10.1371/journal.pone.0277707.g003

DOI: 10.1371/journal.pone.0277707.g004

DOI: 10.1371/journal.pone.0277707.g005

DOI: 10.1371/journal.pone.0277707.t001

DOI: 10.1371/journal.pone.0277707.t002

DOI: 10.1371/journal.pone.0277707.t003

DOI: 10.1371/journal.pone.0277707.s001

DOI: 10.1371/journal.pone.0277707.s002

DOI: 10.1371/journal.pone.0277707.s003

DOI: 10.1371/journal.pone.0277707.s004

DOI: 10.1371/journal.pone.0277707.s005

DOI: 10.1371/journal.pone.0277707.s006

DOI: 10.1371/journal.pone.0277707.r001

DOI: 10.1371/journal.pone.0277707.r002

DOI: 10.1371/journal.pone.0277707.r003

DOI: 10.1371/journal.pone.0277707.r004

DOI: 10.1371/journal.pone.0277707.r005

DOI: 10.1371/journal.pone.0277707.r006

Language: English

Publisher: Public Library of Science (PLoS)

Publication Date: 2022

detail.hit.zdb_id: 2267670-3

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New filovirus disease classification and nomenclature

Kuhn, Jens H. ; Adachi, Takuya ; Adhikari, Neill K. J. ; [et al.]

Springer Science and Business Media LLC ; 2019

In: Nature Reviews Microbiology Vol. 17, No. 5 ( 2019-5), p. 261-263

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In: Nature Reviews Microbiology, Springer Science and Business Media LLC, Vol. 17, No. 5 ( 2019-5), p. 261-263

Type of Medium: Online Resource

ISSN: 1740-1526 , 1740-1534

URL: Article

DOI: 10.1038/s41579-019-0187-4

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2019

detail.hit.zdb_id: 2121463-3

SSG: 12

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