Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
Caleb P Skipper,Katelyn A Pastick,Nicole S Engen,Ananta S Bangdiwala,Mahsa Abassi,Sarah M Lofgren,Darlisha A. Williams,Elizabeth C Okafor,Matthew F Pullen,Melanie R. Nicol,Alanna A Nascene,Katherine Huppler Hullsiek,Matthew P. Cheng,Darlette Luke,Sylvain A. Lother,Lauren J. MacKenzie,Glen Drobot,Lauren E. Kelly,Ilan S. Schwartz,Ryan Zarychanski,Emily G. McDonald,Todd C. Lee,Radha Rajasingham,David R. Boulware +23 more
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TLDR
This randomized, double-blind, placebo-controlled trial evaluated effects of oral hydroxychloroquine on symptoms and disease severity in adult outpatients with early COVID-19.Abstract:
BACKGROUND: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668). SETTING: Internet-based trial across the United States and Canada (40 states and 3 provinces). PARTICIPANTS: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. INTERVENTION: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. MEASUREMENTS: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. RESULTS: Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). LIMITATION: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. CONCLUSION: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. PRIMARY FUNDING SOURCE: Private donors.read more
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Drug treatments for covid-19: living systematic review and network meta-analysis.
Reed A C Siemieniuk,Jessica J Bartoszko,Long Ge,Dena Zeraatkar,Ariel Izcovich,Elena Kum,Hector Pardo-Hernandez,Anila Qasim,Juan Pablo Diaz Martinez,Bram Rochwerg,Francois Lamontagne,Mi Ah Han,Qin Liu,Arnav Agarwal,Arnav Agarwal,Thomas Agoritsas,Derek K. Chu,Rachel Couban,Ellen Cusano,Andrea Darzi,Tahira Devji,Bo Fang,Carmen Fang,Signe Flottorp,Signe Flottorp,Farid Foroutan,Farid Foroutan,Maryam Ghadimi,Diane Heels-Ansdell,Kimia Honarmand,Liangying Hou,Xiaorong Hou,Quazi Ibrahim,Assem M. Khamis,Bonnie Lam,Mark Loeb,Maura Marcucci,Shelley McLeod,Sharhzad Motaghi,Srinivas Murthy,Reem A. Mustafa,Reem A. Mustafa,John Neary,Gabriel Rada,Irbaz Bin Riaz,Behnam Sadeghirad,Nigar Sekercioglu,Lulu Sheng,Ashwini Sreekanta,Charlotte Switzer,Britta Tendal,Lehana Thabane,George Tomlinson,Tari Turner,Per Olav Vandvik,Robin W.M. Vernooij,Andrés Viteri-García,Ying Wang,Liang Yao,Zhikang Ye,Gordon H Guyatt,Romina Brignardello-Petersen +61 more
TL;DR: Glucocorticoids probably reduce mortality and mechanical ventilation in patients with covid-19 compared with standard care and the effectiveness of most interventions is uncertain because most of the randomised controlled trials so far have been small and have important study limitations.
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The first 12 months of COVID-19: a timeline of immunological insights.
TL;DR: A timeline of the major scientific discoveries during the first year of the COVID-19 pandemic showcases the collaborative efforts that enabled the key aspects of the immune response to SARS-CoV-2 to be reported at unprecedented speed.
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Effect of hydroxychloroquine with or without azithromycin on the mortality of coronavirus disease 2019 (COVID-19) patients: a systematic review and meta-analysis.
Thibault Fiolet,Thibault Fiolet,Anthony Guihur,Mathieu E. Rebeaud,Matthieu Mulot,Nathan Peiffer-Smadja,Nathan Peiffer-Smadja,Yahya Mahamat-Saleh,Yahya Mahamat-Saleh +8 more
TL;DR: The aim of this systematic review and meta-analysis was to assess whether chloroquine or hydroxychloroquine with or without azithromycin decreased COVID-19 mortality compared to the standard of care.
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COVID-19 and Solid Organ Transplantation: A Review Article.
TL;DR: Several aspects of COVID-19 in transplantation are summarized, including the immune response to SARS-CoV-2, Sars-Co V-2 diagnostics, clinical outcomes in SOT recipients and end stage kidney disease patients, transplant activity during the pandemic and treatment options for CO VID-19 disease.
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Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.
Christopher C Butler,Jienchi Dorward,Ly-Mee Yu,Oghenekome Gbinigie,Gail Hayward,Benjamin R. Saville,Oliver van Hecke,Nick Berry,Michelle A. Detry,Christina Saunders,Mark Fitzgerald,Victoria Harris,Mahendra Patel,Simon de Lusignan,Emma Ogburn,Philip Evans,Nicholas P B Thomas,FD Richard Hobbs +17 more
TL;DR: In this paper, the effectiveness of azithromycin to treat suspected COVID-19 among people in the community who had an increased risk of complications was evaluated in a randomized trial.
References
More filters
Journal ArticleDOI
The REDCap consortium: Building an international community of software platform partners.
Paul A. Harris,Paul A. Harris,Robert Taylor,Brenda L. Minor,Veida Elliott,Michelle Fernandez,Lindsay O'Neal,Laura McLeod,Giovanni Delacqua,Francesco Delacqua,Jacqueline Kirby,Stephany N. Duda +11 more
TL;DR: The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006, and a broader consortium sharing and support model was created.
Journal ArticleDOI
Remdesivir for the Treatment of Covid-19 - Final Report.
John H. Beigel,Kay M. Tomashek,Lori E. Dodd,Aneesh K. Mehta,Barry S. Zingman,Andre C. Kalil,Elizabeth L. Hohmann,Helen Y. Chu,Annie Luetkemeyer,Susan Kline,Diego Lopez de Castilla,Robert W. Finberg,Kerry Dierberg,Victor F. Tapson,Lanny Hsieh,Thomas F. Patterson,Roger Paredes,Daniel A. Sweeney,William R. Short,Giota Touloumi,David Chien Lye,Norio Ohmagari,Myoung-don Oh,Guillermo M. Ruiz-Palacios,Thomas Benfield,Gerd Fätkenheuer,Mark G. Kortepeter,Robert L. Atmar,C. Buddy Creech,JD Lundgren,Abdel G. Babiker,Sarah Pett,James D. Neaton,Timothy Burgess,Tyler Bonnett,Michelle Green,Mat Makowski,Anu Osinusi,Seema U Nayak,H. Clifford Lane +39 more
TL;DR: The data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection.
Journal ArticleDOI
Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.
Yeming Wang,Yeming Wang,Dingyu Zhang,Guanhua Du,Ronghui Du,Jianping Zhao,Yang Jin,Shouzhi Fu,Ling Gao,Zhenshun Cheng,Qiaofa Lu,Yi Hu,Guangwei Luo,Ke Wang,Yang Lu,Huadong Li,Shuzhen Wang,Shunan Ruan,Chengqing Yang,Chunlin Mei,Yi Wang,Dan Ding,Feng Wu,Xin Tang,Xianzhi Ye,Yingchun Ye,Bing Liu,Jie Yang,Wen Yin,Aili Wang,Guohui Fan,Fei Zhou,Zhibo Liu,Xiaoying Gu,Jiuyang Xu,Lianhan Shang,Lianhan Shang,Yi Zhang,Lianjun Cao,Guo Tingting,Yan Wan,Hong Qin,Yushen Jiang,Thomas Jaki,Thomas Jaki,Frederick G. Hayden,Peter Horby,Bin Cao,Chen Wang +48 more
TL;DR: In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits, however, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
Journal ArticleDOI
In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Xueting Yao,Fei Ye,Miao Zhang,Cheng Cui,Baoying Huang,Peihua Niu,Xu Liu,Li Zhao,Erdan Dong,Chunli Song,Siyan Zhan,Roujian Lu,Haiyan Li,Wenjie Tan,Dongyang Liu +14 more
TL;DR: It is proposed that the immunomodulatory effect of hydroxychloroquine also may be useful in controlling the cytokine storm that occurs late-phase in critically ill SARS-CoV-2 infected patients.
Journal ArticleDOI
Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.
Joshua Geleris,Yifei Sun,Jonathan Platt,Jason Zucker,Matthew R. Baldwin,George Hripcsak,Angelena Labella,Daniel K. Manson,Christine J. Kubin,R. Graham Barr,Magdalena E. Sobieszczyk,Neil W. Schluger +11 more
TL;DR: In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death.
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