Anti–SARS-CoV-2 Antibody Responses in Convalescent Plasma Donors Are Increased in Hospitalized Patients; Subanalyses of a Phase 2 Clinical Study

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Abstract

We evaluated the antibody responses in 259 potential convalescent plasma donors for Covid-19 patients. Different assays were used: a commercial ELISA detecting antibodies against the recombinant spike protein (S1); a multiplex assay detecting total and specific antibody isotypes against three SARS-CoV-2 antigens (S1, basic nucleocapsid (N) protein and receptor-binding domain (RBD)); and an in-house ELISA detecting antibodies to complete spike, RBD and N in 60 of these donors. Neutralizing antibodies (NAb) were also evaluated in these 60 donors. Analyzed samples were collected at a median time of 62 (14–104) days from the day of first symptoms or positive PCR (for asymptomatic patients). Anti-SARS-CoV-2 antibodies were detected in 88% and 87.8% of donors using the ELISA and the multiplex assay, respectively. The multivariate analysis showed that age ≥50 years ( p < 0.001) and need for hospitalization ( p < 0.001) correlated with higher antibody titers, while asymptomatic status ( p < 0.001) and testing >60 days after symptom onset ( p = 0.001) correlated with lower titers. Interestingly, pseudotype virus-neutralizing antibodies (PsNAbs) significantly correlated with spike and with RBD antibodies by ELISA. Sera with high PsNAb also showed a strong ability to neutralize active SARS-CoV-2 virus, with hospitalized patients showing higher titers. Therefore, convalescent plasma donors can be selected based on the presence of high RBD antibody titers.

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Clinical Characteristics of Coronavirus Disease 2019 in China

Wei-jie Guan, Zheng-yi Ni, Yu Hu … (2020)

Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)

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Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Mark Peters (2020)

Abstract Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. Results A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Conclusions In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)

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Remdesivir for the Treatment of Covid-19 — Final Report

John H. Beigel, Kay Tomashek, Lori Dodd … (2022)

Abstract Background Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. Methods We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. Results A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). Conclusions Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.)

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Author and article information

Journal

Journal ID (nlm-ta): Microorganisms

Journal ID (iso-abbrev): Microorganisms

Journal ID (publisher-id): microorganisms

Title: Microorganisms

Publisher: MDPI

ISSN (Electronic): 2076-2607

Publication date (Electronic): 28 November 2020

Publication date Collection: December 2020

Volume: 8

Issue: 12

Electronic Location Identifier: 1885

Affiliations

[1 ]Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, Greece; tsergentanis@ 123456yahoo.gr (T.N.S.); j.charitaki@ 123456gmail.com (I.C.); johnntanasis@ 123456med.uoa.gr (I.N.-S.); e.korompoki@ 123456imperial.ac.uk (E.K.); tbagratuni@ 123456hotmail.co.uk (T.B.); mdimop@ 123456med.uoa.gr (M.A.D.)

[2 ]Hematology Laboratory Blood Bank, Aretaieion Hospital, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, Greece; mpolitou@ 123456med.uoa.gr

[3 ]Public Health Laboratories, Hellenic Pasteur Institute, 11521 Athens, Greece; mentis@ 123456pasteur.gr (A.M.); vlabropoulou@ 123456pasteur.gr (S.L.)

[4 ]Human Retrovirus Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute, Frederick, MD 21702-1201, USA; margherita.rosati@ 123456nih.gov (M.R.); Dimitrios.stellas@ 123456nih.gov (D.S.); george.pavlakis@ 123456nih.gov (G.N.P.)

[5 ]Institute of Chemical Biology, National Hellenic Research Foundation, 48 Vassileos Constantinou Ave., 11635 Athens, Greece

[6 ]Human Retrovirus Pathogenesis Section, Vaccine Branch, Center for Cancer Research, National Cancer Institute, Frederick, MD 21702-1201, USA; jenifer.bear@ 123456nih.gov (J.B.); xintao.hu@ 123456nih.gov (X.H.); barbara.Felber@ 123456nih.gov (B.K.F.)

[7 ]Hematology Unit, Second Department of Internal Medicine, Attikon University General Hospital, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, Greece; vas_pappa@ 123456yahoo.com (V.P.); ampouchla@ 123456med.uoa.gr (A.B.); sotirispapageorgiou@ 123456hotmail.com (S.P.)

[8 ]BMT Unit, Department of Hematology and Lymphomas, Evangelismos General Hospital, 10676 Athens, Greece; marianpagoni@ 123456yahoo.com (M.P.); xgiatra@ 123456gmail.com (C.G.)

[9 ]Department of Transfusion Service and Clinical Hemostasis, “Saint Savvas” Oncology Hospital, 11522 Athens, Greece; egrouzi@ 123456otenet.gr (E.G.); dimitramos@ 123456gmail.com (D.M.)

[10 ]Blood Bank, Evangelismos General Hospital, 10442 Athens, Greece; ssaridak@ 123456gmail.com

[11 ]Department of Internal Medicine, Sotiria General Hospital of Chest Diseases, 11527 Athens, Greece; pefan1@ 123456otenet.gr

[12 ]BMT Unit, University Hospital of Patras, School of Medicine, University of Patras, 26500 Patras, Greece; spyridonidis@ 123456upatras.gr

[13 ]Fourth Department of Internal Medicine, Attikon University General Hospital, School of Medicine, National and Kapodistrian University of Athens, 11527 Athens, Greece; ananto@ 123456med.uoa.gr (A.A.); tsiodras@ 123456med.uoa.gr (S.T.)

[14 ]First Department of Critical Care Medicine and Pulmonary Services, Evangelismos General Hospital, School of Medicine, National and Kapodistrian University of Athens, 11527 Athens, Greece; akotanid@ 123456gmail.com

[15 ]Oncology Unit, Third Department of Medicine, School of Medicine, National and Kapodistrian University of Athens, 11527 Athens, Greece; ksyrigos@ 123456med.uoa.gr

[16 ]Hellenic National Blood Transfusion Center, 13678 Athens, Greece; kostas.stamoulis@ 123456gmail.com

[17 ]Pharmacology Laboratory, School of Medicine, University of Patras, 26500 Patras, Greece; gpanayiotakopoulos@ 123456hotmail.com

[18 ]National Public Health Organization, 15123 Athens, Greece

[19 ]Biomedical Systems Laboratory, National Technical University of Athens, 11527 Athens, Greece; leo@ 123456mail.ntua.gr

Author notes

[* ]Correspondence: eterpos@ 123456med.uoa.gr or eterpos@ 123456hotmail.com ; Tel.: +30-213-2162846; Fax: +30-213-2162511

[†]

Equal contribution as first authors.

[‡]

Equal contribution as last authors.

Author information

Evangelos Terpos https://orcid.org/0000-0001-5133-1422

Dimitris Stellas https://orcid.org/0000-0002-7787-3921

Jenifer Bear https://orcid.org/0000-0001-5065-6081

Meletios A. Dimopoulos https://orcid.org/0000-0001-8990-3254

George N. Pavlakis https://orcid.org/0000-0002-4027-4036

Article

Publisher ID: microorganisms-08-01885

DOI: 10.3390/microorganisms8121885

PMC ID: 7760522

PubMed ID: 33260775

SO-VID: 896de81b-fcd0-4a50-bf48-9cfd145be2d2

License:

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

History

Date received : 29 October 2020

Date accepted : 27 November 2020

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Anti–SARS-CoV-2 Antibody Responses in Convalescent Plasma Donors Are Increased in Hospitalized Patients; Subanalyses of a Phase 2 Clinical Study

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Novel Coronavirus Disease COVID-19

Most cited references 33

Clinical Characteristics of Coronavirus Disease 2019 in China

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Remdesivir for the Treatment of Covid-19 — Final Report

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