scholarly journals Feasibility of SARS-CoV-2 Antibody Testing in Remote Outpatient Trials

2021 ◽  
Author(s):  
Sarah M Lofgren ◽  
Elizabeth C Okafor ◽  
Alanna A Colette ◽  
Katelyn A Pastick ◽  
Caleb P Skipper ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Case Definition ◽  
Antibody Detection ◽  
Rapid Testing ◽  
Antibody Testing ◽  
Global Pandemic ◽  
Positive Antibody ◽  
Epidemiological Link ◽  
Serology Testing

Abstract Background During the Covid-19 pandemic, clinical trials necessitated rapid testing to be performed remotely. Dried blood spot (DBS) techniques have enabled remote HIV virologic testing globally and more recently, antibody testing as well. We evaluated DBS testing for SARS-CoV-2 antibody testing in outpatients to assess seropositivity. Methods In 2020, we conducted three internet-based randomized clinical trials and offered serologic testing via self-collected DBS as a voluntary sub-study. COVID-19 diagnosis was based on CDC case definition with epidemiological link to cases. A minority reported PCR testing at an outside facility. We tested for anti-SARS-CoV-2 immunoglobulin via Antibody Detection by Agglutination-PCR (ADAP) and compared with ELISA. Results Of 2727 participants in the primary studies, 60% (1648/2727) consented for serology testing; 56% (931/1648) returned a usable DBS sample. Of those asymptomatic, 5% (33/707) had positive ADAP serology. Of participants with a positive PCR, 67% (36/54) had positive SARS-CoV-2 antibodies. None of those who were PCR-positive and asymptomatic were seropositive (0/7). Of 77 specimens tested for concordance via ELISA, 83% (64/77) were concordant. Challenges of completing a remote testing program during a pandemic included sourcing and assembling collection kits, delivery and return of the kits, and troubleshooting testing. Self-collection was successful for >95% of participants. Delays in US mail with possible sample degradation and timing of DBS collection complicated the analysis. Conclusion We found remote antibody testing during a global pandemic feasible although challenging. We identified an association between symptomatic COVID-19 and positive antibody results at similar prevalence to other outpatient cohorts.

scholarly journals Potential specific therapies in COVID-19

2020 ◽  
Vol 14 ◽  
pp. 175346662092685 ◽  
Author(s):  
Muhammad Hamdan Gul ◽  
Zin Mar Htun ◽  
Nauman Shaukat ◽  
Muhammad Imran ◽  
Ahmad Khan
Keyword(s):  
Clinical Trials ◽  
Severe Acute Respiratory Syndrome ◽  
Randomized Clinical Trials ◽  
Middle Eastern ◽  
The Other ◽  
Potential Treatment ◽  
Blood Products ◽  
Material Section ◽  
Global Pandemic ◽  
The World

COVID-19 has grown into a global pandemic that has strained healthcare throughout the world. There is a sense of urgency in finding a cure for this deadly virus. In this study, we reviewed the empiric options used in common practice for COVID-19, based on the literature available online, with an emphasis on human experiences with these treatments on severe acute respiratory syndrome-associated coronavirus (SARS-COV-1) and other viruses. Convalescent blood products are the most promising potential treatment for use in COVID-19. The use of chloroquine or hydroxychloroquine (HCQ), remdesivir, and tocilizumab are some of the other promising potential therapies; however, they are yet to be tested in randomized clinical trials (RCTs). The use of lopinavir-ritonavir did not prove beneficial in a large RCT. The use of corticosteroids should be avoided in COVID-19 pneumonia unless used for other indications, based on the suggestion of harm in patients with SARS-COV-1 and Middle Eastern Respiratory Syndrome (MERS) infection. The reviews of this paper are available via the supplemental material section.

scholarly journals Lessons Learned from Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic

2020 ◽  
Author(s):  
Matthew F Pullen ◽  
Katelyn A Pastick ◽  
Darlisha A Williams ◽  
Alanna A Nascene ◽  
Ananta S Bangdiwala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Trial Design ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Online Data ◽  
Global Pandemic ◽  
Patient Reported

Abstract As the SARS-CoV-2 pandemic evolved, it was apparent that well designed and rapidly conducted randomized clinical trials were urgently needed. However, traditional clinical trial design presented several challenges. Notably, disease prevalence initially varied by time and region, and the pockets of outbreaks evolved geographically over time. Coupled with an occupational hazard from in-person study visits, timely recruitment would prove difficult in a traditional in-person clinical trial. Thus, our team opted to launch nationwide internet-based clinical trials using patient-reported outcome measures. In total, 2795 participants were recruited using traditional and social media, with screening and enrollment performed via an online data capture system. Follow-up surveys and survey reminders were similarly managed through this online system with manual participant outreach in the event of missing data. Here, we present a narrative of our experience running internet-based clinical trials and provide recommendations for the design of future clinical trials during a world pandemic.

scholarly journals SARS-CoV-2 Serologic Assays in Control and Unknown Populations Demonstrate the Necessity of Virus Neutralization Testing.

2020 ◽  
Author(s):  
Jennifer A Rathe ◽  
Emily A Hemann ◽  
Julie Eggenberger ◽  
Zhaoqi Li ◽  
Megan Knoll ◽  
...  
Keyword(s):  
Antibody Test ◽  
Negative Control ◽  
Virus Neutralization ◽  
Antibody Detection ◽  
Immune Protection ◽  
Antibody Testing ◽  
Viral Neutralization ◽  
Positive Antibody ◽  
Antibody Assays ◽  
Focus Reduction

Background: To determine how serologic antibody testing outcome links with virus neutralization of SARS-CoV-2 to ascertain immune protection status, we evaluated a unique set of individuals for SARS-CoV-2 antibody detection and viral neutralization. Methods: Herein, we compare several analytic platforms with 15 positive and 30 negative SARS-CoV-2 infected controls followed by viral neutralization assessment. We then applied these platforms in a clinically relevant population: 114 individuals with unknown histories of SARS-CoV-2 infection. Results: In control populations, the best performing antibody detection assays were SARS-CoV-2 receptor binding domain (RBD) IgG (specificity 87%, sensitivity 100%, PPV 100%, NPV 93%), spike IgG3 (specificity 93%, sensitivity 97%, PPV 93%, NPV 97%), and nucleocapsid (NP) protein IgG (specificity 93%, sensitivity 97%, PPV 93%, NPV 97%). Neutralization of positive and negative control sera showed 100% agreement. 20 unknown individuals had detectable SARS-CoV-2 antibodies with 16 demonstrating virus neutralization. The antibody assays that best predicted virus neutralization were RBD IgG (misidentified 2), spike IgG3 (misidentified 1), and NP IgG (misidentified 2). Conclusion: These data suggest that meaningful evaluation of antibody assay performance requires testing in an unknown population. Further, these results indicate coupling of virus neutralization analysis to a positive antibody test is required to categorize patients based on SARS-CoV-2 immune protection status following virus exposure or vaccine administration. One of the antibody detection platforms identified in this study followed by the pseudoneutralization or focus reduction assay would provide a practical testing strategy to assess for SARS-CoV-2 antibodies with optimal prediction of correlates to neutralizing immunity.

scholarly journals COVID-19-associated inflammatory syndrome in an adult woman with unexplained multiple organ failure: staying vigilant for COVID-19 complications as the pandemic surges

2021 ◽  
Vol 14 (4) ◽  
pp. e242034
Author(s):  
Maedeh Veyseh ◽  
Patrick Webster ◽  
Irene Blanco
Keyword(s):  
Organ Failure ◽  
Wide Spectrum ◽  
Organ Damage ◽  
Multiple Organ ◽  
Adult Woman ◽  
Antibody Detection ◽  
Antibody Testing ◽  
Positive Antibody ◽  
Control And Prevention ◽  
Inflammatory Syndrome

Since the emergence of SARS-CoV-2, clinicians have been challenged with a wide spectrum of disease severity. One of the serious complications associated with the virus is multisystem inflammatory syndrome in children (MIS-C). It is characterised by inflammation leading to organ damage, in the setting of positive SARS-CoV-2 infection. MIS-C is thought to be a postviral reaction where most children are negative on PCR testing but are positive for SARS-CoV-2 antibodies. The Centers for Disease Control and Prevention recently defined the same phenomenon occurring in adults as multisystem inflammatory syndrome in adults (MIS-A) and emphasised on the use of antibody testing in this population. Here we describe an adult woman with an exposure to SARS-CoV-2 who presented with unexplained organ failure and shock. Positive antibody testing was the only clue to the diagnosis of MIS-A. We stress the importance of SARS-CoV-2 antibody detection in order to identify these cases.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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