دورية أكاديمية
A multi centre randomized open label trial of chloroquine for the treatment of adults with SARS-CoV-2 infection in Vietnam.
| العنوان: | A multi centre randomized open label trial of chloroquine for the treatment of adults with SARS-CoV-2 infection in Vietnam. |
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| المؤلفون: | Kestelyn E; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Dung NTP; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam., Lam Minh Y; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam., Hung LM; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Quan NM; Thu Duc Hospital, Ho Chi Minh City, Vietnam., Dung NT; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Minh NNQ; Children's Hospital 1, Ho Chi Minh City, Vietnam., Xuan TC; Cu Chi field hospital, Cu Chi, Vietnam., Phong NT; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Ninh Thi Thanh V; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam., Donovan J; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Tu TNH; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Nhat LTH; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam., Truong NT; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Man DNH; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Thao HP; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Ngoc NM; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Lam VT; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Phat HH; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Phuong PM; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam., Geskus RB; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Ha VTN; Administration of Science, Technology and Training (ASTT), Ministry of Health, Hanoi, Vietnam., Quang NN; Administration of Science, Technology and Training (ASTT), Ministry of Health, Hanoi, Vietnam., Tran Tinh H; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Tan LV; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam., Thwaites GE; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Day JN; Oxford University Clinical Research Unit, University of Oxford, Ho Chi Minh City, Vietnam.; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK., Chau NVV; Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam. |
| مؤلفون مشاركون: | OUCRU COVID-19 Research Group |
| المصدر: | Wellcome open research [Wellcome Open Res] 2020 Jun 12; Vol. 5, pp. 141. Date of Electronic Publication: 2020 Jun 12 (Print Publication: 2020). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wellcome Trust Country of Publication: England NLM ID: 101696457 Publication Model: eCollection Cited Medium: Print ISSN: 2398-502X (Print) Linking ISSN: 2398502X NLM ISO Abbreviation: Wellcome Open Res Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : Wellcome Trust, [2016]- |
| مستخلص: | Background : COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19. We hypothesise that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid decline of viral load in throat/nose swabs. This viral attenuation should be associated with improved patient outcomes. Method : The study will start with a 10-patient prospective observational pilot study following the same entry and exclusion criteria as for the randomized trial and undergoing the same procedures. The main study is an open label, randomised, controlled trial with two parallel arms of standard of care (control arm) versus standard of care with 10 days of chloroquine (intervention arm) with a loading dose over the first 24 hours, followed by 300mg base orally once daily for nine days. The study will recruit patients in three sites in Ho Chi Minh City, Vietnam: the Hospital for Tropical Diseases, the Cu Chi Field Hospital, and the Can Gio COVID hospital. The primary endpoint is the time to viral clearance from throat/nose swab, defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs. Viral presence will be determined using RT-PCR to detect SARS-CoV-2 RNA. Discussion: The results of the study will add to the evidence-based guidelines for management of COVID-19. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. Trial registration: Clinicaltrials.gov NCT04328493 31/03/2020. Competing Interests: No competing interests were disclosed. (Copyright: © 2020 Kestelyn E et al.) |
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| معلومات مُعتمدة: | United Kingdom WT_ Wellcome Trust; 204904/Z/16/Z United Kingdom WT_ Wellcome Trust |
| فهرسة مساهمة: | Keywords: COVID-19; Chloroquine; Randomised Clinical Trial; SARS-CoV-2; Vietnam; coronaviruses |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04328493 |
| تواريخ الأحداث: | Date Created: 20201028 Latest Revision: 20240429 |
| رمز التحديث: | 20240429 |
| مُعرف محوري في PubMed: | PMC7573712 |
| DOI: | 10.12688/wellcomeopenres.15936.1 |
| PMID: | 33110944 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2398-502X |
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| DOI: | 10.12688/wellcomeopenres.15936.1 |