Faculty Bibliography
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Challenges and opportunities utilizing an existing research network for new protocols during the COVID-19 pandemic: The special pathogens research network experience [Meeting Abstract]
During the 2014-16 W. Africa outbreak of Ebola virus disease, the US had no mechanism to study investigational treatments rapidly, and individual institutions provided investigational products as emergency investigational new drugs (eINDs). Consequently, determining the optimum care for the disease was not achieved. The Special Pathogens Research Network (SPRN) was established to create the infrastructure to conduct multi-center clinical research to improve outcomes for emerging special pathogens. This included establishing a central IRB at the University of Nebraska Medical Center and 10 collaborative sites across the US. As the COVID-19 outbreak began, the SPRN quickly executed three protocols. We share efficiencies and ideas for future improvements. At the onset of the COVID-19 outbreak, the network established three clinical protocols: 1) a "natural history" protocol for collecting discarded specimens and patient data; 2) a NIAID-sponsored randomized placebo controlled trial with the antiviral drug Remdesivir; and 3) a prospective data and sample collection protocol. We evaluated the IRB approval timeline centrally and at partner sites and the rapidity of first subject enrollment. We assessed aspects that facilitated or hindered the adoption of the different protocols across the network. Central and other site IRB approvals occurred expeditiously. Subjects were enrolled within one day of site approval in all three studies. UNMC enrolled the first US patient in the Remdesivir RCT. IRB approval occurred at all 10 sites within 32 days of central IRB approval; however, contracts for data use and material transfer agreements (DUAs and MTAs) lagged. Consequently, some sites developed their own natural history protocols, rather than adopt a network protocol. In conclusion, the SPRN pre-existing network of 10 sites was able to enroll subjects rapidly at the start of the outbreak, functioning as one unit in many respects. Contracting for specimen collection protocols has proved challenging and thus has impacted the ability to organize and deliver. This continues to be addressed
EMBASE:637504578
ISSN: 0002-9637
CID: 5184302
Remdesivir for the Treatment of Covid-19 - Final Report
BACKGROUND:Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS:We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. 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 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS:Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).
PMID: 32445440
ISSN: 1533-4406
CID: 4637302
Marburg Virus Disease: a Summary for Clinicians
OBJECTIVES/OBJECTIVE:This article is a summary of countermeasures for Marburg virus disease focusing on pathogenesis, clinical features, and diagnostics, with an emphasis on therapies and vaccines that have demonstrated potential for use in an emergency situation, through their evaluation in nonhuman primates (NHPs) and/or in humans. METHODS:A standardized literature review was conducted on vaccines and treatments for each pathogen, with a focus on human and nonhuman primate data published in the last five years. More detail on the methods used are summarized in a companion methods paper. RESULTS:We identified six treatments and four vaccine platforms that have demonstrated potential benefit for treating or preventing infection in humans, through their efficacy in NHPs. CONCLUSION/CONCLUSIONS:We provide succinct summaries of Marburg countermeasures to give the busy clinician a head start in reviewing the literature if faced with a patient with Marburg virus disease. We also provide links to other authoritative sources of information.
PMCID:7397931
PMID: 32758690
ISSN: 1878-3511
CID: 4560122
American journal of tropical medicine & hygiene. 2019:Conference:(68th).DOI: 10.4269/ajtmh.abstract2019
Building an accessible evidence base for medical countermeasure use in bioemergencies-the special pathogen research network initiative [Meeting Abstract]
During the 2014-2016 Ebola virus disease (EVD) outbreak, clinicians lacked a readily available resource cataloguing available medical countermeasures (MCMs) to treat EVD patients in West Africa and other regions. Some patients received investigational interventions under uncontrolled compassionate use protocols. Therefore, the Special Pathogens Research Network (SPRN) of the National Ebola Training and Education Center (NETEC) formed the MCMs Working Group (WG) with members from 10 Regional Ebola and other Special Pathogen Treatment Centers (RESPTC) and NETEC partners. The goal of the MCMs WG is to develop an evidence-informed, easily accessible, practical assessment of potential countermeasures for clinicians managing patients with selected highly hazardous communicable diseases. Pathogens were selected based on 1) ability to cause severe disease; 2) potential to cause large outbreaks; 3) paucity of currently available cleared MCMs; 4) occurrence of nosocomial spread to health care providers; and 5) transmissibility requiring specialized care in a biocontainment unit. After a standardized literature review is conducted, an assessment of potentially available countermeasures is performed by 2-4 subject matter experts, followed by peer review. Pathogens selected to date incluDe Marburg, Lassa, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Crimean Congo Hemorrhagic Fever (CCHF), Nipah, Variola (and Monkeypox) and South American Hemorrhagic Fever (Junin, Machupo, etc.) viruses. The list overlaps with the World Health Organization's list of ?Blueprint? priority diseases. Reviews on seven pathogens are in progress. In conclusion, the NETEC SPRN MCM WG was created to proviDe a preemptive compendium of systematic and clinically relevant summaries of available MCMs for selected pathogens based on pre-specified criteria. Challenges will incluDe updating current documents as new scientific evidence becomes available. Plans are in place for regular review and updates, with the most up-todate materials available on the NETEC website for open-source access
EMBASE:630644686
ISSN: 0002-9637
CID: 4285332
A comprehensive district-level laboratory intervention after the Ebola epidemic in Sierra Leone
Background/UNASSIGNED:The 2014-2016 Ebola outbreak exposed the poor laboratory systems in Sierra Leone. Immense needs were recognised across all areas, from facilities, diagnostic capacity, supplies, trained personnel to quality assurance mechanisms. Objective/UNASSIGNED:We aimed to describe the first year of a comprehensive intervention, which started in 2015, in a public hospital's general laboratory serving a population of over 500 000 in a rural district. Methods/UNASSIGNED:The intervention focused on (1) supporting local authorities and healthcare workers in policy implementation and developing procedures to enhance access to services, (2) addressing gaps by investing in infrastructure, supplies, and equipment, (3) development of quality assurance mechanisms via mentorship, bench-side training, and the introduction of quality control and information systems. All work was performed alongside counterparts from the Ministry of Health and Sanitation. Results/UNASSIGNED:We observed a strong increase in patient visits and inpatient and outpatient testing volumes. Novel techniques and procedures were taken up well by staff, leading to improved and expanded service and safety, laying foundations for further improvements. Conclusion/UNASSIGNED:This comprehensive approach was successful and the results suggest an increase in trust from patients and healthcare workers.
PMCID:6852544
PMID: 31745458
ISSN: 2225-2002
CID: 4208962
Strengthening provision of essential medicines to women and children in post-Ebola Sierra Leone
PMCID:6551484
PMID: 31217949
ISSN: 2047-2986
CID: 3939242
Strengthening the Free Healthcare Initiative through a pharmacy and supply chain intervention: Partners in Health's experience in rural Sierra Leone [Meeting Abstract]
ISI:000398363900011
ISSN: 2214-109x
CID: 2674142
Patterns of Ocular Manifestations in Ebola Virus Disease Survivors in the Port Loko, Sierra Leone [Meeting Abstract]
ISI:000394210203414
ISSN: 0146-0404
CID: 2674122
Factors associated with vision impairment in Ebola virus disease uveitis in Sierra Leone [Meeting Abstract]
ISI:000394210204283
ISSN: 0146-0404
CID: 2674132
Improved Detection of Tuberculosis and Multidrug-Resistant Tuberculosis among Tibetan Refugees, India
The incidence of tuberculosis (TB) among Tibetan refugees in India is 431 cases/100,000 persons, compared with 181 cases/100,000 persons overall in India in 2010. More than half of TB cases in these refugees occur among students, monks, and nuns in congregate settings. We sought to increase TB case detection rates for this population through active case finding and rapid molecular diagnostics. We screened 27,714 persons for symptoms of TB and tested 3,830 symptomatic persons by using an algorithm incorporating chest radiography, sputum smear microscopy, culture, and a rapid diagnostic test; 96 (2.5%) cases of TB were detected (prevalence 346 cases/100,000 persons). Of these cases, 5% were multidrug-resistant TB. Use of the rapid diagnostic test and active case finding enabled rapid detection of undiagnosed TB cases in congregate living settings, which would not have otherwise been identified. The burden of TB in the Tibetan exile population in India is extremely high and requires urgent attention.
PMCID:4766920
PMID: 26889728
ISSN: 1080-6059
CID: 2673942
