Nguồn: NEWS RELEASES, NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19 | Nation Institutes Health (NIH). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health,
Tiến sĩ Anthony Fauci, giám đốc Viện Dị ứng và Bệnh Truyền nhiễm Quốc gia đang phát biểu tại Nhà Trắng về việc thử nghiệm lâm sàng thuốc chống lại COVID-19. (Ảnh: qua Getty Image)
Thử nghiệm giai đoạn hai sẽ bao gồm khoảng 2.000 người trưởng thành mắc bệnh nhẹ hoặc trung bình do căn bệnh mới gây ra bởi virus Corona Vũ Hán.
Nhiều người trong số các bệnh nhân COVID-19 sẽ từ 60 tuổi trở lên hoặc những bệnh nhân hiện đang có sẵn các bệnh như bệnh tiểu đường hoặc bệnh thận, các nhà nghiên cứu cho biết.
Thử nghiệm đang được thực hiện bởi Nhóm thử nghiệm lâm sàng AIDS, nhận được tài trợ từ Viện Dị ứng và Bệnh truyền nhiễm Quốc gia (NIAID).
“Chúng ta đang rất cần một liệu pháp điều trị an toàn và hiệu quả cho COVID-19. Cải tổ mục đích các loại thuốc hiện có là một lựa chọn hấp dẫn bởi vì các loại thuốc này đã trải qua thử nghiệm rộng rãi, cho phép chúng nhanh chóng chuyển sang thử nghiệm lâm sàng và đẩy nhanh sự chấp thuận tiềm năng của chúng đối với điều trị COVID-19’’, tiến sĩ Anthony Fauci, người đứng đầu NIAID, cho biết trong một tuyên bố.
Những bằng chứng lâm sàng đã cho thấy hydroxychloroquine, một loại thuốc thường được sử dụng để điều trị bệnh sốt rét và azithromycin, một loại kháng sinh phổ biến, có thể có tác dụng cho bệnh nhân bị mắc căn bệnh mới, Fauci nói. Một thử nghiệm đủ lớn, ngẫu nhiên, có kiểm soát và tập hợp thành dữ liệu để chứng minh hiệu quả hoạt động của loại thuốc đó.
Mục tiêu chính của nghiên cứu là xác định xem các loại thuốc này có thể ngăn ngừa nhập viện và tử vong do COVID-19 hay không. Kết quả chính là xác định tỷ lệ những người tham gia bị tử vong vì bất kỳ nguyên nhân nào hoặc phải nhập viện.
Các nhà khoa học cũng sẽ điều tra xem các loại thuốc này có an toàn cho những người bị lây nhiễm virus Corona Vũ Hán hay không.
Cả hai loại thuốc này đều có tác dụng phụ từ đau đầu đến nhịp tim không đều. Hydroxychloroquine được chấp thuận cho sử dụng khẩn cấp chống lại COVID-19, nhưng, theo Cục Quản lý Thực phẩm và Dược phẩm, nên được giới hạn sử dụng ở các bệnh viện và thử nghiệm lâm sàng.
Các bệnh nhân tình nguyện tham gia nghiên cứu sẽ nhận được thuốc uống ở nhà. Nhóm điều trị thử nghiệm sẽ nhận được 800 miligam hydroxychloroquine trong ngày đầu tiên và 200 miligam trong sáu ngày tiếp theo. Họ cũng sẽ nhận được 500 miligam azithromycin vào ngày đầu tiên, sau đó là 250 miligam trong bốn ngày tiếp theo.
Nhóm bệnh nhân đối chứng sẽ nhận được liều thuốc giả dược tương đương.
Các chai thuốc hydroxychloroquine đang được đóng gói để mang đi thử nghiệm lâm sàng. (Ảnh qua Getty Image)
Những người tham gia sẽ không biết họ nhận được giả dược hay nhận được thuốc. Kể cả các nhà nghiên cứu cũng sẽ không biết.
Bệnh nhân sẽ ghi lại các triệu chứng của họ, việc họ tuân thủ chế độ phác thảo như thế nào và các sự kiện lớn như nhập viện vào nhật ký trong vòng 20 ngày. Nhân viên nghiên cứu sẽ liên lạc với họ qua điện thoại trong khoảng thời gian đó.
Các cuộc gọi điện thoại tiếp theo sẽ diễn ra trong ba và sáu tháng sau khi bắt đầu điều trị.
Theo danh sách thử nghiệm, ngày hoàn thành chính được dự kiến vào ngày 9 tháng 10 năm 2020. Nghiên cứu đầy đủ được ước tính sẽ hoàn thành vào ngày 5 tháng 3 năm 2021.
Các bệnh nhân đang nhận được mời đăng ký tình nguyên tham gia ở bảy tiểu bang, bao gồm Alabama, California, Ohio và Texas.
Thử nghiệm mới là một trong những thử nghiệm hydroxychloroquine hoặc dược phẩm liên quan gần với chloroquine để chống lại COVID-19.
Một thử nghiệm khác được tài trợ bởi NIAID đã bắt đầu vào tháng trước. Thử nghiệm đó liên quan đến những bệnh nhân nhập viện do COVID-19.
NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19
Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.NIAID
A clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from coronavirus disease 2019 (COVID-19). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating medications for the study.
The Phase 2b trial will enroll approximately 2,000 adults at participating ACTG sites(link is external) across the United States. Study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19, and be experiencing fever, cough and/or shortness of breath. The investigators anticipate that many of those enrolled will be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. Participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos. People living with HIV and pregnant and breastfeeding women also are eligible to participate in the study. The first participant enrolled today in San Diego, California.
“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment,” said NIAID Director Anthony S. Fauci, M.D. “Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”
As of May 13, the World Health Organization (WHO)(link is external) has reported 4.17 million cases of and 287,399 deaths from COVID-19 worldwide. In the United States, 1.36 million confirmed COVID-19 cases and 82,246 deaths have been reported as of May 13, according to the Centers for Disease Control and Prevention (CDC)(link is external).
Currently, there are no specific therapeutics approved by the U.S. Food and Drug Administration to treat people with COVID-19. Hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus. Some preliminary reports have suggested that hydroxychloroquine, alone or in combination with the FDA-approved antibiotic azithromycin, may benefit people with COVID-19. Numerous clinical trials are planned or underway, including a recently launched study supported by NIH’s National Heart, Lung and Blood Institute evaluating the safety and effectiveness of hydroxychloroquine for treatment of adults hospitalized with COVID-19. On March 28, FDA issued an Emergency Use Authorization(link is external) (EUA) to allow hydroxychloroquine and medical-grade chloroquine to be distributed from the Strategic National Stockpile and prescribed by doctors to hospitalized adolescents and adults with COVID-19, as appropriate, when a clinical trial is not available or feasible.
Participants in the ACTG study, called A5395, will receive oral medications to take at home. Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four days. The control group will receive equivalent numbers of placebo pills. Neither the participants nor the study team will know who received experimental treatment or placebo until the end of the trial.
Participants will record their symptoms, adherence to treatment, and major events such as hospitalizations in a diary for 20 days. Study staff will follow up with participants by telephone during this period. When possible, participants will come to the clinical research site for an in-person visit at day 20. Additional follow-ups will be conducted by telephone three and six months after treatment starts.
The main objective of the study is to determine whether hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19. Additionally, investigators will evaluate the safety and tolerability of the experimental treatment for people with SARS-CoV-2 infection. While hydroxychloroquine and azithromycin are both considered safe in most people, they can cause side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening. Because of the risk of heart problems when hydroxychloroquine is used alone or combined with azithromycin, FDA cautions that use of hydroxychloroquine for COVID-19 should be limited to clinical trials or for treating certain hospitalized patients under EUA(link is external) so clinicians can monitor patients for adverse effects.
“This study will provide key data to aid responses to the COVID-19 pandemic,” said ACTG Chair Judith Currier, M.D., of the University of California, Los Angeles. “We are pleased to be able to leverage ACTG’s existing infrastructure for HIV treatment clinical trials to quickly implement this important study.”
The study team is led by Protocol Chair Davey Smith, M.D., of the University of California, San Diego. David Wohl, M.D., of the University of North Carolina at Chapel Hill, and Kara W. Chew, M.D., and Eric S. Daar, M.D., both of the University of California, Los Angeles, serve as protocol vice-chairs. The trial is expected to enroll quickly given the high incidence of COVID-19, and initial results may be available later this year.
For more information about A5395, visit ClinicalTrials.gov and search identifier NCT04358068. Adults interested in participating in the study should email actg.communications@fstrf.org(link sends e-mail).
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.NIAID
The Phase 2b trial will enroll approximately 2,000 adults at participating ACTG sites(link is external) across the United States. Study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19, and be experiencing fever, cough and/or shortness of breath. The investigators anticipate that many of those enrolled will be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. Participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos. People living with HIV and pregnant and breastfeeding women also are eligible to participate in the study. The first participant enrolled today in San Diego, California.
“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment,” said NIAID Director Anthony S. Fauci, M.D. “Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”
As of May 13, the World Health Organization (WHO)(link is external) has reported 4.17 million cases of and 287,399 deaths from COVID-19 worldwide. In the United States, 1.36 million confirmed COVID-19 cases and 82,246 deaths have been reported as of May 13, according to the Centers for Disease Control and Prevention (CDC)(link is external).
Currently, there are no specific therapeutics approved by the U.S. Food and Drug Administration to treat people with COVID-19. Hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus. Some preliminary reports have suggested that hydroxychloroquine, alone or in combination with the FDA-approved antibiotic azithromycin, may benefit people with COVID-19. Numerous clinical trials are planned or underway, including a recently launched study supported by NIH’s National Heart, Lung and Blood Institute evaluating the safety and effectiveness of hydroxychloroquine for treatment of adults hospitalized with COVID-19. On March 28, FDA issued an Emergency Use Authorization(link is external) (EUA) to allow hydroxychloroquine and medical-grade chloroquine to be distributed from the Strategic National Stockpile and prescribed by doctors to hospitalized adolescents and adults with COVID-19, as appropriate, when a clinical trial is not available or feasible.
Participants in the ACTG study, called A5395, will receive oral medications to take at home. Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four days. The control group will receive equivalent numbers of placebo pills. Neither the participants nor the study team will know who received experimental treatment or placebo until the end of the trial.
Participants will record their symptoms, adherence to treatment, and major events such as hospitalizations in a diary for 20 days. Study staff will follow up with participants by telephone during this period. When possible, participants will come to the clinical research site for an in-person visit at day 20. Additional follow-ups will be conducted by telephone three and six months after treatment starts.
The main objective of the study is to determine whether hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19. Additionally, investigators will evaluate the safety and tolerability of the experimental treatment for people with SARS-CoV-2 infection. While hydroxychloroquine and azithromycin are both considered safe in most people, they can cause side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening. Because of the risk of heart problems when hydroxychloroquine is used alone or combined with azithromycin, FDA cautions that use of hydroxychloroquine for COVID-19 should be limited to clinical trials or for treating certain hospitalized patients under EUA(link is external) so clinicians can monitor patients for adverse effects.
“This study will provide key data to aid responses to the COVID-19 pandemic,” said ACTG Chair Judith Currier, M.D., of the University of California, Los Angeles. “We are pleased to be able to leverage ACTG’s existing infrastructure for HIV treatment clinical trials to quickly implement this important study.”
The study team is led by Protocol Chair Davey Smith, M.D., of the University of California, San Diego. David Wohl, M.D., of the University of North Carolina at Chapel Hill, and Kara W. Chew, M.D., and Eric S. Daar, M.D., both of the University of California, Los Angeles, serve as protocol vice-chairs. The trial is expected to enroll quickly given the high incidence of COVID-19, and initial results may be available later this year.
For more information about A5395, visit ClinicalTrials.gov and search identifier NCT04358068. Adults interested in participating in the study should email actg.communications@fstrf.org(link sends e-mail).
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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Nguồn: News Release, NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19 | Nation Institutes Health (NIH). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health,
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