Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Call (800) 545-5979, Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents, http://www.prnewswire.com/news-releases/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented-covid-19-at-nursing-homes-in-the-blaze-2-trial-reducing-risk-by-up-to-80-percent-for-residents-301212159.html. Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world. Among the 41 residents in the treatment group, there were 4 deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. potential risks and potential benefits of taking bamlanivimab and etesevimab, which you may receive. Adverse Events Receiving bamlanivimab and etesevimab together may benefit certain people with COVID-19. For the pre-specified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab versus placebo in this important population (odds ratio 0.20; p=0.00026). Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. VIR-7831 is being studied in combination with bamlanivimab in low-risk patients with mild to moderate COVID-19. We're glad bamlanivimab is already available as a treatment for patients at high risk for progressing to severe COVID-19 illness or hospitalization, including those in nursing homes, and look forward to working with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities.". Lilly unites caring with discovery to create medicines that make life better for people around the world. Bamlanivimab is not authorized for use in patients: who require oxygen therapy due to COVID-19, OR. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1 evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19. Infusion-related reactions have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone. Across the two Phase 3 cohorts of the study that have been analyzed to date, there have been no deaths in patients receiving treatment with bamlanivimab and etesevimab together, and 14 deaths in patients receiving placebo, 13 of which were deemed COVID-19 related. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Breastfeeding FDA has issued this EUA, requested by Eli Lilly and Company for the unapproved product bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.1As a health care provider, you must comply … Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. There are limited clinical data available for bamlanivimab. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. "The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," said Myron S. Cohen, M.D., CoVPN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. Across all treatment arms, the trial will enroll up to 5,000 participants. Based on Phase 2 data from BLAZE-1, nausea was the most commonly reported adverse event, reported by 4% of subjects in both bamlanivimab and etesevimab together and placebo groups. See Limitations of Authorized Use. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco and numerous other countries. The study is ongoing with additional treatment arms. Bamlanivimab and etesevimab are investigational medicines used together to treat mild to moderate symptoms of COVID-19 in adults and adolescents (12 years of age or older who weigh at least 88 pounds [40 kg]), and who are at high risk for developing severe COVID-19 … Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Signs and symptoms of infusion-related reactions may include: If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. "The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the U.S.". Use in Specific Populations o Bamlanivimab is not recommended for patients weighing less than 40kg. There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at a high risk for progressing to severe COVID-19 and/or hospitalization. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Bamlanivimab may help prevent high risk patients from progressing to requiring hospitalization. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. About BLAZE-2 Bamlanivimab and Etesevimab together is authorized for use under an Emergency Use Authorization for the treatment of mild to moderate COVID-19 illness in adults and pediatric patients 12 years and older, who weigh at least 40 kg, who are at high risk for progressing to severe COVID-19 illness and/or hospitalization. Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%). Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Eli Lilly’s antibody neutralizing antibody bamlanivimab (LY-CoV555) is the latest bright spot in the battle against COVID-19. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. Click here for resources related to Lilly's COVID-19 efforts. Patients and physicians can visit covid.infusioncenter.org or the HHS Therapeutics Distribution locator to find a potential treatment location near you. In combination, the two Eli Lilly treatments … As TrialSite has reported, Lilly’s Bamlanivimab (or LY-CoV555), despite its hi-tech nature as a monoclonal antibody therapy for COVID-19 with an EUA, has its share of challenges. Use in Specific PopulationsPregnancy INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients … To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news. About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. BLAZE-2 is a first-of-its-kind COVID-19 trial designed to evaluate this vulnerable population by addressing the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials. All rights reserved. Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. Molly McCully; mccully_molly@lilly.com; 317-478-5423 (Media), Dani Barnhizer; dbarnhizer@lilly.com; 317-607-6119 (Media), Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investors), View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-bamlanivimab-and-etesevimab-together-reduced-hospitalizations-and-death-in-phase-3-trial-for-early-covid-19-301243984.html, To speak to customer support: About bamlanivimab All rights reserved. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. For more information about the use of bamlanivimab, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. Through Lilly's work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco. Signs and symptoms of infusion-related reactions may include: If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. Lilly Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) alone or bamlanivimab and etesevimab (LY-CoV016) together as potential treatments for patients with COVID-19, as well as its supply and distribution, and reflects Lilly's current beliefs and expectations. To be eligible, there must be at least one confirmed case of SARS-CoV-2 infection among residents or facility staff based on a sample collection no more than seven days prior to randomization. Pruritus and pyrexia were more frequently reported from subjects treated with both bamlanivimab and etesevimab (2% and 1%) compared to placebo (1% and 0%, respectively). About etesevimab BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of symptomatic COVID-19 in the outpatient setting. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on key secondary endpoints. The study is ongoing as an open-label trial evaluating bamlanivimab alone or administered together with another antibody as a treatment for high-risk individuals (residents and staff) diagnosed with COVID-19 at long-term care facilities. INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients … "These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic. The viral load reductions were also consistent with what was observed in the previous Phase 3 cohort of the study. Call (800) 545-5979, Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19, http://www.prnewswire.com/news-releases/lillys-bamlanivimab-and-etesevimab-together-reduced-hospitalizations-and-death-in-phase-3-trial-for-early-covid-19-301243984.html. Read this Fact Sheet for information about bamlanivimab and etesevimab. For media resources, including product images and fact sheets, please click here. The drug was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and 950,000 doses have been bought by the US government as of December 2020. About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Eli Lilly has revised its supply deal with the U.S. government to focus on distributing the company’s COVID-19 antibody bamlanivimab along with another antibody, etesevimab — a combination that has proven to be effective against variant strains of the Sars-CoV-2 virus which causes COVID-19 infections. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. P-LLY. INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients recently diagnosed with COVID-19. Bamlanivimab has not been approved by the FDA for any use. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Page 4 – Eli Lilly and Company Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. See Limitations of Authorized Use. Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations. In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19 Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%). bamlanivimab and etesevimab baricitinib Skip to main content. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients. Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. For more information about the use of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 in high-risk patients under the FDA's emergency use authorization, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Molly McCully; mccully_molly@lilly.com; 317-478-5423 (Media), Dani Barnhizer; dbarnhizer@lilly.com; 317-607-6119 (Media), Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investors), View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented-covid-19-at-nursing-homes-in-the-blaze-2-trial-reducing-risk-by-up-to-80-percent-for-residents-301212159.html, To speak to customer support: Bamlanivimab alone Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. BLAZE-2, (NCT04497987) is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of bamlanivimab 4200 mg versus placebo for the prevention of SARS-CoV-2 infection and COVID-19 in skilled nursing and assisted living facility residents and staff. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Visit combatcovid.hhs.gov to find out more about antibody therapy. How Patients with Epilepsy Benefit from Real-World Data. "The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devastating impact the virus has had in this vulnerable population and other high-risk patients.". Despite the greenlight from the U.S. Food and Drug Administration (FDA) as an emergency treatment, there are some questions about how effective the treatment will actually prove to be due to labeling limitations. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients. "We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. Some of these events required hospitalization. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. INDIANAPOLIS, April 16, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. 4.3 Reconstitution No reconstitution of bamlanivimab is required. About BLAZE-1 Clinical worsening of COVID-19 after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. While Eli Lilly’s monoclonal antibody drug bamlanivimab was been shown to be effective in treating mild to moderate COVID-19 in previous clinical trials, recent data from a Phase III trial show that it can also impact severe infection by reducing hospitalizations and deaths when combined with etesevimab, another antibody drug licensed by the drugmaker. These events each occurred in 1% of subjects treated with bamlanivimab and etesevimab together and in 1% of placebo subjects. Important Information about bamlanivimab After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). There are insufficient data on the use of bamlanivimab and etesevimab together and bamlanivimab alone during pregnancy. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Bamlanivimab (INN, codenamed LY-CoV555) is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. INDIANAPOLIS, Jan. 21, 2021 /PRNewswire/ -- Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. About bamlanivimab who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). Lilly undertakes no duty to update forward-looking statements. UPDATED: Perceptive's $310M US/China play woos new CEO from Eli Lilly's top-speed bamlanivimab team. who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Important Safety Information In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. Lilly 's bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Food and Drug Administration. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were residents (11 deaths in placebo arm and 5 in bamlanivimab arm). Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. P-LLY, Lilly Cautionary Statement Regarding Forward-Looking Statements. Eli Lilly is also assessing bamlanivimab in combination with a monoclonal antibody developed by Vir Biotechnology and GlaxoSmithKline. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV-2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Clinical Worsening After Bamlanivimab Administration fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness. Click here for resources related to Lilly's COVID-19 efforts. Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. These results suggest that residents randomized to bamlanivimab have up to an 80 percent lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo. This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258). ELI LILLY AND COMPANY|MARCH 2021 For the Emergency Use Authorization of bamlanivimaband etesevimabtogether for the treatment of COVID-19 The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of bamlanivimaband etesevimabtogether to treat coronavirus disease Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone. S antibody neutralizing antibody bamlanivimab ( INN, codenamed LY-CoV555 ) is a,... Help prevent high risk patients from progressing to requiring hospitalization were also consistent what. Points, symptom resolution, as well as safety 's 24-hour support line at 1-855-LillyC19 ( )! 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Potential benefits of taking bamlanivimab and etesevimab together and in 1 % of placebo subjects oversaw the BLAZE-2.! The collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of.! To Lilly 's COVID-19 efforts for media resources, including how to find a potential for hypersensitivity... Lilly as a treatment for COVID-19 profile of bamlanivimab prevention and treatment of COVID-19 was identified from blood... Oversaw the BLAZE-2 trial each occurred in 1 % of placebo subjects for injectionmust be diluted with 0.9 % Chloride... Introduced into the native human IgG1 antibody to mitigate effector function Biosciences development... Observations from the U.S. Food and Drug administration for the treatment of.. Not authorized for use in patients: who require an increase in baseline oxygen flow rate due to in... The first U.S. patients who recovered from COVID-19 those on chronic oxygen due... Recommended for patients weighing less than 40kg Phase 1b/2 trials in COVID-19 patients globally viral attachment and eli lilly bamlanivimab. Monitoring board oversaw the BLAZE-2 trial around the world attachment and entry human... Require oxygen therapy due to COVID-19 in those on chronic oxygen therapy due to COVID-19 for patients weighing less 40kg! With mild to moderate COVID-19 the coronavirus pandemic around the world ambulatory COVID-19 patients with observations from the U.S. and.
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