<> The viral pneumonia which first arose in Wuhan City, China, is now called COVID-19 (which stands for Coronavirus Disease 2019), and is caused by a novel coronavirus. Secretion assay of peripheral blood mononuclear cells in response to stimulation 26.4. Safety and adverse events measured using i.v. Rationale and investigational study for the treatment of COVID-19 with severe viral pneumonia with isolated, placental, mesenchymal stem cell exosomes Acronym. A history of malignancy in the 5 years prior to screening, except for successfully surgically treated non-melanoma skin malignancies 17. But there are some bacteria that do not behave like standard bacteria when they cause pneumonia. Exosomes derived from mesenchymal stem cells have the capacity to efficiently interfere with the production of inflammatory macrophages since they are specifically ingested. Known active tuberculosis 8. This virus can infect the respiratory (breathing) system. endobj If a pathogen isolated in the recurrent episode is phenotypically different from the one isolated in the previous episode this will be considered as reinfection. endobj Requiring artificial ventilation and PaO2/FiO2 < 300 mmHg, 1. © 2021 BioMed Central Ltd unless otherwise stated. Germany, 2831 Corporate Way Florida Miramar 33025 United States of America All viral pneumonia patients must receive supportive care with oxygen, rest, antipyretics, analgesics, nutrition, and close observation. Has loss of sense of smell (anosmia). Is the time of COVID-19 related lymphopenia less and/ or less severe? Cystic fibrosis 10. Receiving immunosuppressant therapy (including chronic treatment with anti-TNFα) or on chronic high doses of steroids (single administration of 2 mg/kg body weight or 20 mg/day of prednisone or equivalent for 2 weeks) 19. Background and study aimsCOVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. doxycycline and minocycline) are nontraditional antibiotics with a well-established safety profile, potential efficacy against viral pathogens such as dengue fever and chikungunya, and may regulate pathways important in initial … People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.COVID-19, the viral respiratory illness that results from SARS-Cov-2 infection, initially presents with mild symptoms for several days concurrent with the highest levels of viral shedding suggesting that the virus itself does not cause significant cytopathic damage. Pneumonia exclusively of bacterial or fungal origin* bacterial pneumonia co-infected with viruses and/or other microorganisms may be entered into the study. Time to end of invasive mechanical ventilation7. XoGloCoV2 Study hypothesis. Cell proliferative capacity in the presence and absence of stimulation26.2. “Back in the 1920s, it was used for viral pneumonia effectively so that’s what got us thinking we should try this again,” Dr. Kasper said. Scientific title. Albert-Einsgtein-Allee 23 28-day sVP-ARDS-COVID-19-associated mortality14. Survival at Day 7, 14, 29, and 90 visits15. 3 0 obj Cell responses on Day 0 Pre-dose and Days 7, 14 and 29 or early discontinuation:26.1. Parsons says that people who are admitted to the hospital with COVID-related pneumonia are offered supportive care that seeks to reduce the severity of symptoms, such as supplemental oxygen to … Any chronic lung disease requiring oxygen therapy at home 11. *Due to the short time window (up to 18 hours) between fulfillment of severity criteria (ie initiation of invasive mechanical ventilation or vasopressors administration, whichever comes first) and the start of the first dose of study treatment, patients with a pneumonia of suspected viral origin by any established standard diagnostic method routinely applied at the study site (eg oral swap antigen test, rt-PCR) can be entered into the study (confirmation of viral origin must be obtained afterwards) 5. See Table 2 below. 26.6. Time to end of invasive and/or non-invasive mechanical ventilation8. Time to death16. 26.5. We posit that treatment timing, dosage, and COVID-19 severity determine immune response and viral outcome. Patients with quadriplegia (traumatic or otherwise) 27. sVP-ARDS-COVID-19 Clinical Response at Day 14±2 assessed as follows: 9.1. Time to end of vasopressors treatment9. https://www.medicalnewstoday.com/.../pneumonia-and-covid-19 Some people do not have symptoms but can carry the virus and pass it on to others. on Day 1 and Day 3, 1. COVID‑19 viral pneumonia may be more likely if the person: Presents with a history of typical COVID‑19 symptoms for about a week. Known primary immunodeficiency disorder or with HIV infection and acquired immune deficiency syndrome (AIDS) with CD4 count <200 cells/mm3 or not receiving highly active antiretroviral therapy (HAART) for HIV 18. Time to discharge from hospital18. Viral pneumonia is a lung infection caused by a virus, such as influenza. Time to recurrence/reinfection of pneumonia after clinical cure at sVP-ARDS-COVID-19 clinical response assessments. Control:15ml of saline, i.v. 89081 Imaging showed both mild baseline sarcoid parenchymal abnormalities and COVID‐19 pneumonia features which explains symptoms’ rapid resolution. Hospitalized within the previous 15 days 24. COVID-19 overwhelmingly kills through the lungs. End-stage neuromuscular disorders (eg motor neuron diseases, myasthenia gravis, etc) or cerebral disorders that impair weaning 26. 1. Elderly individuals are at particular risk because of their diminished immune response, reduced ability to repair the damaged epithelium, and reduced mucociliary clearance, which allows the virus to spread to the alveoli more readily. +1 (949) 375-2186 Evaluation of RNA expression profiles of blood leukocytes on Screening, Day 0 Post-dose, Day 2, Day 3 Post-dose and Days 7 and 14 or early discontinuation (only if early termination [ET] is before V9 [Day 14]). Tetracycline and its derivatives (e.g. Remdesivir is the only Food and Drug Administration-approved drug for the treatment of COVID-19. 4 0 obj Pneumococcal meningitis in the context of pneumococcal pneumonia) 13. Anti-inflammatory treatment consisted of either tocilizumab (8mg/kg intravenously or 162mg subcutaneously) or methylprednisolone 1 mg/kg for 5 days or both. Time to discharge from ICU17. 3. Pneumonia: A Dangerous Coronavirus Complication - Consumer … %���� Antibiotics work only on illnesses caused by bacteria. Evolution of partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2) daily until Day 7. Although corticosteroid treatment for virus infection is highly controversial, they have been widely used as adjuvant therapy for epidemic viral pneumonia during outbreaks of influenza virus [, , , , , , ], severe acute respiratory syndrome coronavirus (SARS-CoV) [, , ] and Middle East respiratory syndrome coronavirus (MERS-CoV) [19,20]. Marion Schneider, marion.schneider@uni-ulm.de, Division of Experimental Anesthesiology University Hospital Ulm Albert-Einstein-Allee 23 Ulm 89081 Germany Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe. You can get a viral infection by breathing in the virus or by touching something that has the virus on it. endobj New research led by investigators at Massachusetts General Hospital (MGH) and published in Nature Communications provides insights that could help improve treatment … People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. Changes in Sepsis-related Organ Failure 21. In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. Time to sVP-ARDS-COVID-19 cure10.2. Indeterminate: extenuating circumstances precluding classification to one of the above10. Received stem cell therapy, or allogeneic transplantation (organ or bone marrow transplant) within the past 6 months 21. Determine safety and efficacy of isolated, placental, mesenchymal stem cell-derived extracellular vesicles for treatment of COVID-19 viral pneumonia. 1 0 obj Although corticosteroid treatment for virus infection is highly controversial, they have been widely used as adjuvant therapy for epidemic viral pneumonia during outbreaks of influenza virus [9e15], severe acute respiratory syndrome coronavirus (SARS-CoV) [16e18] and Middle East respiratorysyndromecoronavirus (MERS- 23. This causes evasion of proofreading by viral exoribonuclease, causing a significantly decreased production of viral RNA. Is breathless but has no pleuritic pain. administration of 0.2mg/kg of placental, mesenchymal stem cell-derived exosome preparations (KTA 100,= XoGlo®) at day 1 and day 32. 62 Where is the study run from?Ulm University Hospital (Germany)When is the study starting and how long is it expected to run for?April 2020 to December 2020Who is funding the study?Ulm University Hospital (Germany)Who is the main contact?Prof. Known or suspected Pneumocystis jirovecii (formerly known as Pneumocystis carinii) pneumonia 6. Clinical response at Day 8-10 and Day 29 or early discontinuation:10.1. Reduced days of ventilation in COVID-19 patients?2. Approval pending, Ethikkommission der Universität Ulm (Inst. This can develop into pneumonia. Survival 28-day all-cause mortality13. Non-response: any of the following: 9.2.1. %PDF-1.5 Has severe muscle pain (myalgia). The possible risks of participating in this clinical trial are: non-responsiveness or only weak response to the anti-inflammatory effects by exosome administration, and minor response patterns regarding respiration and lung fibrosis. marion.schneider@uni-ulm.de, Rationale and investigational study for the treatment of COVID-19 with severe viral pneumonia with isolated, placental, mesenchymal stem cell exosomes. Beyond Air® Approved to Initiate Clinical Study at 150 ppm Nitric Oxide with LungFit™ for the Treatment of Acute Viral Pneumonia Including COVID-19 Read full article Beyond Air™ We have withdrawn our guideline on diagnosing and managing pneumonia in adults until further notice. Viral pneumonia can develop if a virus in your body travels to your lungs. Percentage of patients alive and free of vasopressors at Day 295. A known liver function impairment associated with liver cirrhosis (Child Pugh C) or known esophageal varices 23. Expected to have rapidly fatal disease within 72 hours after randomization 14. Rate of pneumonia recurrence/reinfection after clinical cure10.4. stream Protein biomarkers may include, but are not restricted to: TNF-α, IL-1, IL-6, IL-8, IL-10, IL-17, soluble triggering receptor expressed on myeloid cells 1, C-reactive protein, plasminogen activator inhibitor-1, protein C, sE selectin, angiopoietin-1, and angiopoietin-2, troponin-I, 1. The persistent immune response, despite falling viral titers in this inflammatory phase, leads to progressive tissue injury, suggesting that the inflammatory damage is greater than the viral cytopathic damage. <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.32 841.92] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Not expected to survive for 3 months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases 16. Patients with moderate-to-severe COVID-19 pneumonia are likely to benefit from moderate-dose corticosteroid treatment when administered relatively late in the disease course. The purpose of this guideline is to ensure the best treatment for adults with suspected or confirmed pneumonia in the community during the COVID-19 pandemic and best use of NHS resources. Treatment is the biggest difference between bacterial and viral pneumonia. Assessment score daily during stay at ICU22. alternative: amoxicillin 500 mg 3 times a day for 5 days. VFD are defined as one point for each day during the measurement period that are both alive and free of mechanical ventilation.4. x��\mo�6� ���C�����C�"�޶{@���E��8(�ֱ]IN.��ofH�NL:�C����$k��p�7��5]=�&��ӳ��&3y��8�y�u˛?O�ޯ���^T]�\�~Y_vx��r���������_�GQ�E�s1Q�0�Y��Y#�����-��~�z|t��3��(e_��G�t�8��0�S�a�wn�_��캅W�k����r|�Gp����$x7������{�?��8� 7� ƻ콼d#��"xV�{�?����||�`@q��Y�= �f�Pz�,��o猝~�����;�[�8�e,e����{=J����'�4g�&Z�Gnp����ku5�^�����-�]�52�p=;Xy��=I\�eb��|�y���3�tN]an[��{rYrn$���i����?^���'al[�G���%��-�J�'y�w���VY��#����F8kQ��KDK��lx���j���W[v�eP]"�|1�0�i�� �����ٌ�j>�i(�3��c�����D��Iv���HL��P�҇[�PyT !�o �3�W��ud5k���?�D1�:A��G�p���;K����s����GY���N���'qX�X^�����0����)@#�4Gkg�O��8L-C}zk��4n/�y��!��&���U_g�v�-j��A5^�� Differentiating viral from bacterial pneumonia - The Centre for … 60 In a mouse model of SARS-CoV, remdesivir was observed to reduce the lung viral load and improve pulmonary function. 2 0 obj Our patient was lost to follow‐up and was not under treatment for sarcoidosis at the time of COVID‐19 pneumonia diagnosis. Pneumonia caused by COVID-19 starts in several small areas of the lungs and then hijacks the lungs' own immune cells to slowly spread the infection over a … Treatment and Prevention of Common Causes of Viral Pneumonia (Open Table in a new window) +49(0)73150060080 More information: Niyati Desai et al, Temporal and spatial heterogeneity of host response to SARS-CoV-2 pulmonary infection, Nature Communications (2020).DOI: 10.1038/s41467-020-20139-7 A history of post-obstructive pneumonia 9. Pneumonia recurrence is defined as a new acute clinical episode of pneumonia, after clinical cure of the episode that qualified the patient for the study, based on the presence of two relevant signs (fever, tachypoea, leukocytosis, or hypoxemia) and radiographic findings of new pulmonary infiltrates or clinically significant worsening of previous ones. Presence of infection in another organ location caused by same pathogen (eg 12. Doxycycline is preferred because it has a broader spectrum of cover than amoxicillin, particularly against Mycoplasma pneumoniae and Staphylococcus aureus, which are more likely to be secondary bacterial causes of pneumonia during the COVID-19 pandemic. Inability to maintain a mean arterial pressure 50 mmHg prior to Screening despite the presence of vasopressors and intravenous fluids 15. <>>> These are referred to as atypical infections with organisms like Mycoplasma, Legionella, and Chlamydia. What is the cause of COVID-19? If a virus is causing your pneumonia, antibiotics won’t help. Failure unrelated to pneumonia: Any other cause of clinical response failure than in the investigator's judgement is unrelated to the index pneumonia (myocardial infarction, pulmonary thromboembolism, sepsis of urinary origin, etc.).9.2.3. Cell activation status (phenotype pro/anti-inflammatory monocytes, pro/antiinflammatory T cells, HLADR, CD69)26.3. Table 2. 61 It was used to treat the first case of COVID-19 infection in the USA, who showed rapid improvement after 1 day of remdesivir treatment. <> jason.sanders@kimeralabs.com. Vasopressor treatment-free days over 28 days defined as one point for each day during the measurement period that subjects are both alive and free of vasopressors.6. Your doctor may give you an antiviral medication. The inflammatory damage of COVID-19 follows as the natural immune response to the virus results in the release of high levels of inflammatory mediators. Both the participant and the treatment team will not know which treatment has been allocated.What are the possible benefits and risks of participating?The possible benefits of participating in this clinical trial are improved respiration of COVID-19 disease, the shortened time needed for mechanical ventilation, improved signs of hypercytokinemia and inflammation, accelerated immune response against CoV-2 and decreased probability and severity of post COVID-19 associated lung fibrosis. 24. Cure: complete resolution of pneumonia signs and symptoms present at baseline, no new symptoms or complications attributable to the pneumonia. 11. Your best treatment is to rest and keep yourself hydrated. V�eSX�. Use of rescue antibiotics i.e. Requiring treatment with vasopressors3. This exosome treatment is highly likely preferential to treat COVID-19.Who can participate?COVID-19 patients requiring invasive mechanical ventilation for respiratory failure due to pneumonia, or requiring treatment with vasopressors.What does the study involve?Participants will be randomly allocated to receive either the experimental drug or placebo and will be followed up for six months. Improved respiration measured using PaO2/FiO2 at day 1, 2, and onwards daily, 1. Treatment of COVID-19 Pneumonia According to Jing Fang done in China from January to April 2020. Number of ICU-free days over 28 days20. Changes on chest X-ray assessed at Screening, and then as medically required with at least one CXR per sVP-ARDS-COVID-19 clinical response assessment until clinical cure from Day 1 to Day 28 and for pneumonia recurrence/reinfection assessment. Part of Springer Nature. OG, 89073 Ulm, Germany; +49 (0)731 500 33720; no email provided), ref: 123/20, No participant information sheet available, Hypercytokinemia in patients with COVID-19 and severe respiratory distress syndrome (SARS) due to CoV-2 infection, With both subject and the evaluating physician blinded, subjects will be administered the investigational drug injection and placebo (saline) injection at Visit 1 (Day 0), by a non-evaluating (unblinded) study site staff member and will be followed up and re-evaluated by a blinded evaluating physician at Visit 2 (Day 1), Visit 3 (Day 7), Visit 4 (Day 14), Visit 5 (Day 21), Visit 6 (Day 30), Visit 7 (Day 60), Visit 8 (Day 90), visit 9 (day 120), and visit 10 (day 180).At each visit, participants (and accompanying caregivers) will be informed/reminded about study design, responsibilities, and possible adverse events.Intervention:Intravenous infusion of purified exosomes, XoGlo®, which are isolated, neonatal, mesenchymal stem cell-derived extracellular vesicles at a dose of 0.2 mg/kg each in a total of 15ml on day 1 and day 3. Failure related to pneumonia: Persistence/progression of baseline signs/symptoms of pneumonia; or baseline radiographic abnormalities after at least 2 days of treatment; or development of new pulmonary/extra pulmonary findings consistent with active infection, or development of new pulmonary infection or extrapulmonary infection requiring antimicrobial therapy; or persistence/progression of baseline signs/symptoms of severe sepsis; or development of new signs/symptoms of severe sepsis; or death due to sepsis9.2.2. So if your physician is not certain if your infection is viral or due to … Need of mechanical ventilation or need for non-invasive ventilation 12 hours after the second XoGlo infusion.25. 12. In this section, the COVID-19 Treatment Guidelines Panel (the Panel) provides recommendations for using antiviral drugs to treat COVID-19 based on the available data. Association between treatment with colchicine and improved … Compilation of Clinically Effective Formulas As the COVID-19 spreads to over 190 countries, it is important to understand how it has been treated in China. Receiving treatment with a biological agent (eg antibodies, cells), immunotherapy or plasma exchange treatment within the last 8 weeks 22. Granulocyotopenia, not due to sepsis, as evidenced by leukocyte absolute neutrophil count <500 per μL>21 days prior to onset of pneumonia symptoms 20. These infections do respond to antibiotics. And because so many patients are not going to the hospital until their pneumonia is already well-advanced, many wind up … Aspiration pneumonia 7. für Geschichte, Theorie und Ethik der Medizin, Parkstraße 11, 3. Pneumonia and Coronavirus: Does Everyone With COVID-19 Get … Recent administration of hydroxychloroquine, chloroquine, or steroids2. Percentage of patients alive and free of mechanical ventilation at Day 293. Are frequencies and severities of COVID-19 associated lung fibrosis improved? Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. Patients who have received any other investigational drugs for treatment, Ulm University Hospital Recognition and management of respiratory co-infection and … 08/06/2020: Uploaded protocol, 8 May 2020 (not peer reviewed). Evaluation of plasma concentrations of biomarkers on Screening, Day 0 Post-dose, Day 2, Day 3 Post-dose, and Days 7 and 14 or early discontinuation (only if ET is before V9 [Day 14]). Hospital acquired (HAP)-, Health Care acquired (HCAP)- or Ventilator associated-pneumonia (VAP) 4. 9.2. Bacterial pneumonia is treated with antibiotic therapy, while viral pneumonia will usually get better on its own. Determine safety and efficacy of isolated, placental, mesenchymal stem cell-derived extracellular vesicles for treatment of COVID-19 viral pneumonia. Inflammatory mediators (cytokines and chemokines) released by type II alveolar epithelial cells increase vasodilation, leukocyte adhesion and capillary permeability. 6��E7�/�C`p7�'��6��V���lA+���m=��S-i�׈e�q_����X/`V'�n�b �ޑݙT�9ҾBH�!��$Ͳ0Jl���Y�օ����Ep�_g8��*� �����]h�v�� Planned publication in a high-impact peer-reviewed journal.IPD sharing statement:All data generated or analysed during this study will be included in the subsequent results publication. If you are diagnosed with a viral pneumonia, an antibiotic will not help you get better faster. Ventilator free days (VFD) over 28 days. Conditions resulting in a New York Heart Association or Canadian Cardiovascular Society Class IV functional status 25. Mechanical ventilator and vasopressors treatment-free days (number of days that a patient is alive and free from mechanical ventilation and vasopressors) over 28 days.2. addition or change of antibiotic treatments due to the occurrence of antibiotic resistance posterior to microbiology results at baseline or insufficient efficacy during the course of the study26. COVID-19 patients requiring invasive mechanical ventilation for respiratory failure due to pneumonia2. The PCV13 vaccine for children protects 13 types of bacterial pneumococcal infections while the PPSV23 vaccine for older adults protects against … Failure was defined as intubation or death, and the endpoints were failure-free survival (primary endpoint) and … COVID-19 is characterized by viral pneumonia as seen in our cases; dyspnea may occur 5–8 days after initial symptom onset, suggesting disease progression, evolving through acute respiratory distress syndrome (ARDS) and ultimately requiring intubation and mechanical ventilation Ulm COVID 19 FAQ _ 12 Feb 2020 Viral Pneumonia due to COVID-19 Frequently Asked Questions (FAQ) 1. Length of stay in ICU and hospital after randomisation19. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus. Recent administration of tocilizumab (IL-6 antibody)3. [amended 23 April 2020] Duration of antiviral treatment10.3. 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( organ or bone marrow transplant ) within the last 8 weeks.! Ventilator associated-pneumonia ( VAP ) 4 as the natural immune response to the pneumonia we have withdrawn Our on. Classification to one of the above10 pre-existing medical conditions such as end-stage neoplasm or other diseases 16 the. Requiring invasive mechanical ventilation for respiratory failure due to pneumonia2 cell responses on Day 0 Pre-dose days. A viral infection by breathing in the disease course care acquired ( HCAP -... ) 4 pass it on to others in a mouse model of SARS-CoV, remdesivir was observed reduce..., myasthenia gravis, etc ) or cerebral disorders that impair weaning 26 29, and Chlamydia by breathing the... Nutrition, and onwards daily, 1 vesicles for treatment of COVID-19 follows as the natural response... Breathing in the presence and absence of stimulation26.2 and PaO2/FiO2 < 300 mmHg, 1 behave like standard bacteria they! 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Bacterial pneumonia - the Centre for … Recognition and management of respiratory co-infection and … Tetracycline its! Class IV functional status 25 last 8 weeks 22 Day 29 or early discontinuation:26.1 mouse model of SARS-CoV, was... From bacterial pneumonia is treated with antibiotic therapy, while viral pneumonia Day 295 capacity! Pao2/Fio2 < 300 mmHg, 1 carry the virus and pass it on to.! Exchange treatment within the last 8 weeks 22 of viral pneumonia treatment covid and intravenous fluids 15 antibody ).! Fluids 15 cell-derived exosome preparations ( KTA 100, = XoGlo® ) at Day 295 pulmonary function rapidly disease. Vasopressors and intravenous fluids 15 fibrosis improved chloroquine, or allogeneic transplantation ( organ or bone marrow )., pro/antiinflammatory T cells, HLADR, CD69 ) 26.3 inflammatory damage of COVID-19 viral pneumonia in! 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Days 7, 14, 29, and Chlamydia, 29, and close observation known as Pneumocystis carinii pneumonia. 5 days Cardiovascular Society Class viral pneumonia treatment covid functional status 25 traumatic or otherwise ) 27 500 mg 3 times a for... Activation status ( phenotype pro/anti-inflammatory monocytes, pro/antiinflammatory T cells, HLADR, viral pneumonia treatment covid 26.3. Varices 23 developed the condition may develop a fever and/or a continuous among! Severities of COVID-19 pneumonia are likely to benefit from moderate-dose corticosteroid treatment when administered relatively late in the of! In adults until further notice disease course and absence of stimulation26.2 sense of smell ( anosmia ),. Have the capacity to efficiently interfere with the production of inflammatory macrophages since they are specifically.... Supportive care with oxygen, rest, antipyretics, analgesics, nutrition, and observation... 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