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Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.

Webb et al. (2020) propose a novel process regarding how to prioritize the allocation of COVID-19 drugs via emergency use authorization (EUA) and pre-approval access (PAA) pathways such as Expanded...

Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units within an Academic Medical Center (AMC), including those part of the Clinical and Translational Science Award (CTSA) consortium, have provided support for clinicians in navigating these options prior to the pandemic. As such, they were positioned to be a resource for accessing therapies during the COVID-19 public health emergency. Methods: A small survey and a follow-on poll of the national Investigational New Drug (IND)/Investigational Device Exemption (IDE) Workgroup were conducted in October and December 2020 to determine whether CTSA regulatory units assisted in facilitating access to COVID-19 therapies and the extent of pandemic-related challenges these units faced. Results: Fifteen survey and 21 poll responses were received, which provided insights into the demands placed on these regulatory support units due to the pandemic and the changes required to provide critical support during this and future crises. Key changes and lessons learned included the importance of regulatory knowledge to support the institutional response, the critical need for electronic submission capacity for Food and Drug Administration (FDA) documents, and the nimble reallocation of regulatory and legal resources to support patient access to investigational agents and/or medical devices during the pandemic. Conclusion: AMC- and CTSA-based regulatory units played a meaningful role in the COVID-19 pandemic but further unit modifications are needed for enabling more robust regulatory support in the future.

Objectives This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). Background Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. Methods A cleaning and sterilization protocol was developed that includes washing CIEDs in an enzymatic detergent, screw cap and set screw replacement, brushing, inspection, and sterilization in ethylene oxide. Validation testing was performed to assure compliance with accepted standards. Results With cleaning, the total mean bioburden for each of 3 batches of 10 randomly chosen devices was reduced from 754 to 10.1 colony-forming units. After sterilization with ethylene oxide, with 3 half-cycle and 3 full-cycle processes, none of the 90 biological indicator testers exhibited growth after 7 days. Through cleaning and sterilization, protein and hemoglobin concentrations were reduced from 99.2 to 1.42 μg/cm 2 and from 21.4 to 1.03 μg/cm 2 , respectively. Mean total organic carbon residual was 1.44 parts per million (range 0.36 to 2.9 parts per million). Endotoxin concentration was not detectable at the threshold of Conclusions CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10 –6 .

The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration's expanded access pathway and the pathway created by the more recent Right to Try Act. In this issue of the Hastings Center Report, with a critical focus on patients, industry, and the research enterprise, Kelly Folkers and colleagues frame the inherent challenges that these pathways are meant to solve and have also inadvertently created. But an additional key focus is how the relevant situations should be managed at the bedside and how the system risks both inefficient and inequitable access to options at the institutional level. Although either pathway could be helpful to patients, the challenges of having the pathways coexist are greater than the sum of their parts. Individual clinicians represent the front line of the regulatory and eligibility challenges of expanded access and right to try, making clinical education a critical component of a comprehensive approach to using them well. But it is medical institutions that must take the lead on supporting access to investigational options in the most equitable and effective manner possible.

Pacemaker therapy is inaccessible to most patients with bradycardia in Africa. Use of reconditioned pacemakers has been proposed as a safe, efficacious, and ethical means of delivering this therapy. A collaboration between PASCAR, Pace4Life, and Project My Heart Your Heart is working to address this deficit in health care in Africa.

Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D-printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D-printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D-printed bioresorbable implantable device.

Purpose The Food and Drug Administration Expanded Access (EA) program and “Right-to-Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right-to-Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements.

Sleep apnea affects more than half of patients with acute ischemic stroke and is associated with poor stroke outcome. This pilot study assessed the feasibility of a randomized, sham-controlled continuous positive airway pressure (CPAP) trial in subjects with acute ischemic stroke. Subjects identified with sleep apnea based on an apnea-hypopnea index ≥5 on overnight polysomnography or portable respiratory monitoring within 7 days of onset of stroke symptoms were randomized to receive active or sham CPAP for a 3-month period. Objective usage was ascertained by compliance data cards. Subjects, treating physicians, and outcome assessors were masked to intervention allocation. Among 87 subjects who provided consent, 74 were able to complete sleep apnea screening, 54 (73%) of whom had sleep apnea. Thirty-two subjects agreed to randomization. Of the 15 subjects who commenced active titration, 11 (73%) took the device home, and 8 (53%) completed the 3-month follow-up. Of the 17 subjects who commenced sham titration, 11 (65%) took the sham device home and completed the 3-month follow-up. The median cumulative usage hours over the 90 days were similar in the active group (53 hours; interquartile range, 22-173 hours) and the sham group (74 hours; interquartile range, 17-94 hours), and blinding to subject condition was successfully maintained. This first-ever randomized, sham-controlled trial of CPAP in patients with recent stroke and sleep apnea demonstrates that sham treatment can be an effective placebo.

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

OBJECTIVES/SPECIFIC AIMS: Expanded Access is an avenue for patients with no available treatment options to access investigational drugs and devices for clinical therapy. This process requires physicians treating these patients to submit requests to the FDA and the local IRB, processes which are typically unfamiliar to clinicians. METHODS/STUDY POPULATION: With the goal of reducing burden and ensuring access to investigational products, Michigan Medicine established the Expanded Access Oversight Committee in January 2015. This committee brought together key stakeholders to develop appropriate policy and infrastructure to support these requests. RESULTS/ANTICIPATED RESULTS: Outcomes from this committee have resulted in a uniform process with a single point of entry for interested physicians and patients. With standardized policy implemented across the institution, a revised IRB application has been developed that is more tailored to Expanded Access and an informed consent document has been developed specific to the clinical use of investigational therapies. To ensure timely execution of these agreements, the contracts office has streamlined the process for negotiating Expanded Access agreements with manufacturing companies. Further development has begun with the Michigan Clinical Research Unit to provide space for clinical visits in Expanded Access cases, allowing for initiation of outpatient therapy. These changes have allowed Michigan Medicine to support triple the number of Expanded Access requests, including more than 45 Expanded Access requests in fiscal year 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Institutional support for Expanded Access requests within a large academic medical center is feasible and can increase access to investigational therapies bfor patients.

Background A high prevalence of obstructive sleep apnea (OSA) symptoms was reported in patients with asthma. Our goal was to evaluate factors associated with habitual snoring and OSA risk in these patients. Methods Patients with asthma were surveyed at specialty clinics with the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ) and questions about the frequency of asthma symptoms (National Asthma Education and Prevention Program guidelines), followed by medical record review. SA-SDQ scores ≥ 36 for men and ≥ 32 for women defined high OSA risk. Logistic regression was used to model associations with habitual snoring and high OSA risk. Results Among 244 patients, 37% snored habitually and 40% demonstrated high OSA risk. Independent predictors of habitual snoring included gastroesophageal reflux disease (GERD) [odds ratio (OR), 2.19; 95% confidence interval (CI), 1.19 to 4.02] and use of an inhaled corticosteroid (ICS) [OR, 2.66; 95% CI, 1.05 to 6.72]. High OSA risk was predicted by asthma severity step (OR, 1.59; 95% CI, 1.23 to 2.06), GERD (OR, 2.70; 95% CI, 1.51 to 4.83), and ICS use (OR, 4.05; 95% CI, 1.56 to 10.53). Linear, dose-dependent relationships of ICS with habitual snoring and high OSA risk were seen (p = 0.004 and p = 0.0006, respectively). Women demonstrated a 2.11 times greater odds for high OSA risk (95% CI, 1.10 to 4.09) when controlling for the above covariates. Conclusions Symptoms of OSA in patients with asthma are predicted by asthma severity, coexistent GERD, and use of an ICS in a dose-dependent fashion. The well-recognized male gender predominance for OSA symptoms is not apparent in these patients. Further exploration of these relationships may help to explain the increased prevalence of OSA in asthma and provide new insights into the reported female predominance of asthma morbidity.

Three‐dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D‐printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D‐printed bioresorbable implantable device.

Background and purpose Patients with asthma often complain of daytime sleepiness, which is usually attributed to a direct effect of asthma on nocturnal sleep quality. We investigated this and other potential explanations for daytime sleepiness among asthmatics. Patients and methods One hundred fifteen adult asthmatics were assessed for perceived daytime sleepiness (one question item), subjective sleepiness (Epworth Sleepiness Scale score, ESS), obstructive sleep apnea risk (Sleep Apnea scale score within Sleep Disorders Questionnaire, SA-SDQ), asthma severity step, relevant comorbid conditions, and current asthma medications. Results Among all subjects, 55% perceived excessive daytime sleepiness and 47% had ESS>10. Most subjects reported snoring ( n =99, or 86%) and many snored habitually ( n =44, 38%). The ESS correlated with SA-SDQ ( P P =0.01), and asthma severity step ( P =0.04). In a multiple regression model, the ESS was independently associated with SA-SDQ ( P =0.0003) and male gender ( P =0.02), but not with asthma severity step ( P =0.51). There were no correlations between ESS and age, body mass index (BMI), forced expiratory volume in one second as percent of predicted value (FEV 1 %), comorbidities, or medication used to treat asthma. Conclusions Sleepiness is common in asthmatics and may reflect occult obstructive sleep apnea more often than effects of asthma itself, other comorbid conditions, or asthma medications.

Non-invasive positive pressure ventilation (NIV) treatment of advanced respiratory insufficiency prolongs survival in ALS. To investigate the critical question of whether earlier initiation of NIV might provide additional benefit, a randomized trial with an appropriate placebo is needed. This study evaluated sub-therapeutic (sham) continuous positive airway pressure as a potential placebo. In a single-blind design, 40 ALS patients with forced vital capacity>50% were randomized to receive 30 seconds (s) of either active NIV, with 8 cm H2O inspiratory and 4 cm H2O expiratory pressure, or sham NIV with

Objective To determine useful cutoffs on the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ) in an epilepsy population. Background Epilepsy and obstructive sleep apnea (OSA) frequently coexist, and treating OSA in epilepsy patients may reduce seizure frequency and improve daytime sleepiness. The SA-SDQ, a 12-item validated measure of sleep-related breathing disorders, may be a useful tool to screen epilepsy patients for OSA, although appropriate cutoff points have not been established in this population. Previously suggested SA-SDQ cutoff points for OSA in a non-epilepsy population were 32 for women and 36 for men. Patients and methods One hundred twenty-five subjects with epilepsy undergoing polysomnography completed a survey about their sleep, including the 12-item SA-SDQ scale. Receiver-operating characteristics curves were constructed to determine optimal sensitivity and specificity. Results Sixty-nine of the 125 subjects (45%) had apnea–hypopnea indices greater than five, indicating OSA. The area under the curve was 0.744 for men and 0.788 for women. For men, an SA-SDQ score of 29 provided a sensitivity of 75% and a specificity of 65%. For women, an SA-SDQ score of 26 provided a sensitivity of 80% and a specificity of 67%. Conclusions The SA-SDQ is a useful screening instrument for OSA in an epilepsy population. Our results indicate that the previously suggested cutoffs for OSA (36 for men and 32 for women) may be too high for this specific population. We suggest screening cutoffs of 29 for men and 26 for women.

The Prescription Drug User Fee Act (PDUFA) has undergone authorization five times, most recently as part of the FDA Safety and Innovation Act (FDASIA) signed into law on July 9, 2012. PDUFA V covers fiscal years 2013–2017 beginning on October 1, 2012. Section 1136 of FDASIA includes a requirement that submissions to FDA be in electronic format. To implement this requirement, FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) issued a Draft Guidance (January 2013) on the standards and format of electronic submissions including electronic Common Technical Document (eCTD) format.1 FDA will issue the Final Guidance no later than 12 months from the close of the 60‐day public comment period upon the Draft Guidance. The Final Guidance and subsequent revisions will be binding on sponsors, applicants, and manufacturers no earlier than 24 months (36 months for Investigational New Drug [IND] submissions) after issuance of the Final Guidance. In short, the transition to mandatory eCTD compliance for drugs and biologic submissions is swiftly approaching. The Center for Devices and Radiologic Health (CDRH) has already issued its Final Guidance for “eCopy” standards in December 2012.2 For drugs and biologics, PDUFA V electronic submission mandates for eCTD do not apply to noncommercial research conducted by academic sponsor‐investigators. However, academics are required to comply with the eCopy guidelines of CDRH. One could then question if eCTD capability for academia is even desirable given that transition from paper can be a resource‐intensive process. The fact is that with PDUFAV mandates, the FDA submission practices of eCTD‐compliant industry and academia will continue to diverge. On a number of levels, this divergence can complicate the translation of academic discoveries into private sector opportunities and biomedical advances. Clinical research at academic medical centers significantly and increasingly contributes to discovery, development, and repurposing of FDA‐approved products. In addition to Institutional Review Board approval, such studies commonly require FDA oversight through IND or Investigational Device Exemption (IDE) submissions to FDA. An increasing number of academic medical centers offer regulatory support for their academic sponsor‐investigators who hold these INDs and IDEs. First described by Dr. Harvey Arbit, these support units offer significant value to investigators and the university; they can reduce regulatory compliance risk while accelerating biomedical advances.3 We propose that like industry, academic regulatory affairs units, technology transfer offices, and the university research enterprise could benefit from the efficiencies and benefits of “eSub” capability. Presently, we describe one high‐volume regulatory support program at a large academic health center and its acquisition of eSub capability for drugs (paper IND to eCTD) and devices (paper IDE to eCopy). We describe the steps involved and their challenges, some of which are likely unique to a non‐industry setting. We also discuss our use of expert technical consulting and software solutions. Finally, we postulate how eSubmissions will impact our regulatory operations metrics, our agency interaction, and our industry interaction. It is our hope that sharing this information will assist other academic health centers that are thoughtfully considering an investment in this technology.

Objective: Small uncontrolled series suggest that treatment of obstructive sleep apnea (OSA) in patients with epilepsy may improve seizure control. Prior to conducting a definitive randomized controlled trial, we addressed critical design issues in a pilot study. Methods: We identified a cohort of adult patients with medically refractory epilepsy and coexisting OSA, documented by polysomnography (PSG). After an 8-week baseline period, subjects with OSA were randomized to therapeutic or sham continuous positive airway pressure (CPAP) for 10 weeks. Subjects maintained seizure calendars and antiepileptic drug dosages were held constant. Results: Sixty-eight subjects with suspected OSA were enrolled and 35 subjects randomized to therapeutic CPAP (22 subjects) or sham (13 subjects) CPAP. Male gender and an elevated sleep apnea questionnaire score were predictive of OSA on PSG. Nineteen subjects in the therapeutic group and all 13 subjects in the sham group completed the trial. Baseline apnea-hypopnea index (AHI) and CPAP adherence were comparable between groups. A significant reduction in AHI was observed in the therapeutic CPAP group as compared to the sham group. Subjects, study coordinators, and principal investigators were unable to predict treatment allocation. Conclusions: This pilot study provided critical information related to study design and feasibility for planning a comprehensive trial to test the hypothesis that treating obstructive sleep apnea in patients with epilepsy improves seizure control.

We performed this analysis of possible first night effects (FNEs) on sleep and respiratory parameters in order to evaluate the need for two serial night polysomnograms (PSGs) to diagnose obstructive sleep apnea (OSA) in epilepsy patients.As part of a pilot multicenter clinical trial investigating the effects of treating sleep apnea in epilepsy, two nights of PSG recording were performed for 40 patients with refractory epilepsy and OSA symptoms. Sleep architecture was examined in detail, along with respiratory parameters including apnea/hypopnea index (AHI) and minimum oxygen saturation. Analysis included two-tailed t-tests, Wilcox sign rank analysis, and Bland Altman measures of agreement.Total sleep time differed between the two nights (night 1,363.8 min + 59.4 vs. 386.3 min + 68.6, p = 0.05). Rapid eye movement (REM) sleep and percentage of REM sleep were increased during night two (night 1: 12.3% + 5.9 vs. night 2: 15.5% + 6.2, p = 0.007), and the total minutes of slow-wave sleep (SWS) were increased (night 1: 35.6 + 60.7 vs. night 2: 46.4 + 68.1, p = 0.01). No other sleep or respiratory variables differed between the two nights. Given an AHI inclusion criterion of five apneas per hour, the first PSG identified all but one patient with OSA.Respiratory parameters showed little variability between the first and second nights. Sleep architecture was mildly different between the first and second PSG night. Performing two consecutive baseline PSGs to diagnose OSA may not be routinely necessary in this population.

Objective To determine the effect of treating obstructive sleep apnea (OSA) on seizure frequency in adults and children with epilepsy in a prospective study. Several case series documented an improvement in seizure control with treatment of coexisting OSA, but published series did not sample a clinic population, were not prospective in design, and did not account for concurrent changes in antiepileptic drug (AED) doses or levels. Patients and methods Adult patients and the parents of pediatric patients seen in the University of Michigan Epilepsy and Pediatric Neurology Clinics were given validated questionnaires. Thirteen adults (aged 20–56) and 5 children (aged 14–17) were selected for polysomnography (PSG) based on frequency of seizures and risk for OSA. Seizure frequency was compared during 8-week baseline and treatment phases and AED levels were done to document stability in medication levels. Results Six of 13 adults and 3 of 5 children met PSG criteria for OSA. Three adults and 1 child were treated with continuous positive airway pressure (CPAP), were tolerant of the device, and had no change in AED doses; all four had at least a 45% reduction in seizure frequency during CPAP treatment. One adult was treated with an oral appliance with a reduction in nocturnal seizures only, and 2 adults and 2 children were intolerant of CPAP. Conclusions Treatment of OSA in patients with epilepsy may improve seizure control and a large randomized placebo-controlled trial appear warranted.

Significance Since its emergence in China in December 2019, SARS-CoV-2 has caused a global pandemic. Repurposing of FDA-approved drugs is a promising strategy for identifying rapidly deployable treatments for COVID-19. Herein, we developed a pipeline for quantitative, high-throughput, image-based screening of SARS-CoV-2 infection in human cells that led to the identification of several FDA-approved drugs and clinical candidates with in vitro antiviral activity., The global spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the associated disease COVID-19, requires therapeutic interventions that can be rapidly identified and translated to clinical care. Traditional drug discovery methods have a >90% failure rate and can take 10 to 15 y from target identification to clinical use. In contrast, drug repurposing can significantly accelerate translation. We developed a quantitative high-throughput screen to identify efficacious agents against SARS-CoV-2. From a library of 1,425 US Food and Drug Administration (FDA)-approved compounds and clinical candidates, we identified 17 hits that inhibited SARS-CoV-2 infection and analyzed their antiviral activity across multiple cell lines, including lymph node carcinoma of the prostate (LNCaP) cells and a physiologically relevant model of alveolar epithelial type 2 cells (iAEC2s). Additionally, we found that inhibitors of the Ras/Raf/MEK/ERK signaling pathway exacerbate SARS-CoV-2 infection in vitro. Notably, we discovered that lactoferrin, a glycoprotein found in secretory fluids including mammalian milk, inhibits SARS-CoV-2 infection in the nanomolar range in all cell models with multiple modes of action, including blockage of virus attachment to cellular heparan sulfate and enhancement of interferon responses. Given its safety profile, lactoferrin is a readily translatable therapeutic option for the management of COVID-19.