GY48LS6

Кеймбридж
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Хлорохин (Chloroquine)
Международное непатентованное наименование Хлорохин (Chloroquine)
Торговое наименование Делагил
Производитель, страна Meda Pharma GmbH & Co.KG, Germany
Лекарственная форма таблетки, 250 мг
Статус препарата

Статус Emergency use authorization (EUA) FDA отозван 15 июня 2020 г.

Механизм действия

Mechanisms may include inhibition of viral enzymes or processes such as viral DNA and RNA polymerase, viral protein glycosylation, virus assembly, new virus particle transport, and virus release. Other mechanisms may also involve ACE2 cellular receptor inhibition, acidification at the surface of the cell membrane inhibiting fusion of the virus, and immunomodulation of cytokine release.

Опыт использования

Pre-clinical data in vitro suggest chloroquine has activity has activity against SARS-CoV-2.

 

There have been reports of potential benefit in inhibiting the exacerbation of pneumonia patients with SARS-CoV-2 infection; however, specific data are not available.

 

Some protocols include recommendations for use.

 

Additional data regarding clinical efficacy for COVID-19 are being evaluated.

 

Safety Concerns:

  • Risk of cardiac arrhythmias (e.g., QT prolongation)
  • Risk of retinal damage, especially with long term use
  • Caution in patients with G6PD deficiency
  • Caution in diabetics
  • Significant drug interactions
Публикации COVID-19

Mayla Gabriela Silva Borba, Fernando de Almeida Val, et al. Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study). April 16, 2020. DOI: 10.1101/2020.04.07.20056424v2.

 

Kome Gbinigie and Kerstin Frie. Should chloroquine and hydroxychloroquine be used to treat COVID-19? A rapid review. 

 

Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of chloroquine phosphate supplied from the strategic national stockpile for treatment of COVID-19 in certain hospitalized patients.

 

Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 Mar 11:105938. doi: 10.1016/j.ijantimicag.2020.105938. 

 

Cortegiani A, Ingoglia G, Ippolito M, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care 2020 Mar 10. PMID: 32173110.

 

Colson P, Rolain J, Lagier J, et al. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents 2020. PMID: 32145363.

 

Gao J, T Zhenxue, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends 2020;14(1):72-73. PMID: 32074550.

 

Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Research 2020;30:269–271. PMID: 32020029.

 

Italian Society of Infectious and Tropical Diseases. Handbook for the care of people with disease-COVI 19. Edition 2.0, March 13, 2020.

 

Savarino A, Trani LD, Donatelli I, et al. New insights into the antiviral effects of chloroquine. The Lancet 2006;6:67-9. PMID: 16439323.

 

Barnard DL, Day CW, Bailey K, et al. Evaluation of immunomodulators, interferons and known in vitro SARS-coV inhibitors for inhibition of SARS-coV replication in BALB/c mice. Antivir Chem Chemother. 2006;17(5):275-84.

Клинические исследования
1.
Название протокола Multi-centre Randomised Controlled Trial of Chloroquine/Hydroxychloroquine Versus Standard of Care for Treatment of Mild Covid-19 in HIV-positive Outpatients in South Africa
Дата начала и окончания КИ May 1, 2020 - July 31, 2021
Название организации, проводящей КИ University of Cape Town
Страны South Africe
Фаза III
Кол-во пациентов 560
2.
Название протокола The Results of COVID 19 Treatment: A Real-life Experience on Patients With COVID 19
Дата начала и окончания КИ April 30, 2020 - December 2029
Название организации, проводящей КИ Tanta University
Страны Egypt
Фаза II-III
Кол-во пациентов 120
3.
Название протокола Clinical Study Evaluating the Efficacy of Chloroquine in COVID-19 Treatment
Дата начала и окончания КИ April 17, 2020 - December 1, 2030
Название организации, проводящей КИ Tanta University
Страны Egypt
Фаза II-III
Кол-во пациентов 40
4.
Название протокола Clinical Study Evaluating the Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment
Дата начала и окончания КИ April 17, 2020 - December 1, 2030
Название организации, проводящей КИ Tanta University
Страны Egypt
Фаза II-III
Кол-во пациентов 60
5.
Название протокола A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)
Дата начала и окончания КИ April 16, 2020 - December 31, 2020
Название организации, проводящей КИ Medical University of Vienna
Страны Austria
Фаза II-III
Кол-во пациентов 500
6.
Название протокола IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT
Дата начала и окончания КИ April 15, 2020 - April 2021
Название организации, проводящей КИ University of Alberta
Страны Canada
Фаза -
Кол-во пациентов 500
7.
Название протокола Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
Дата начала и окончания КИ April 15, 2020 - May 30, 2020
Название организации, проводящей КИ Beth Israel Deaconess Medical Center
Страны Israel
Фаза IV
Кол-во пациентов 400
8.
Название протокола Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
Дата начала и окончания КИ April 14, 2020 - May 28, 2021
Название организации, проводящей КИ Beth Israel Deaconess Medical Center
Страны Israel
Фаза IV
Кол-во пациентов 400
9.
Название протокола An Open Label Cluster Randomized Controlled Trial of Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19
Дата начала и окончания КИ April 14, 2020 - May 14, 2021
Название организации, проводящей КИ UMC Utrecht
Страны Netherlands
Фаза IV
Кол-во пациентов 950
10.
Название протокола Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Дата начала и окончания КИ April 6, 2020 - April 30, 2021
Название организации, проводящей КИ Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Страны Greece
Фаза II
Кол-во пациентов 60
11.
Название протокола Proactive Prophylaxis With Azithromycin and Chloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19
Дата начала и окончания КИ April 6, 2020 - March 31, 2021
Название организации, проводящей КИ Chronic Obstructive Pulmonary Disease Trial Network
Страны Denmark
Фаза II
Кол-во пациентов 226
12.
Название протокола Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Effectiveness and Safety of Chloroquine Phosphate in Combination With Telemedicine in the Reduction of Risk of Disease-related Hospitalization or Death, in Ambulatory Patients With COVID-19 at Particular Risk of Serious Complications
Дата начала и окончания КИ April 6, 2020 - December 31, 2020
Название организации, проводящей КИ Wroclaw Medical University
Страны Poland
Фаза IV
Кол-во пациентов 400
13.
Название протокола WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection
Дата начала и окончания КИ April 4, 2020 - August 1, 2021
Название организации, проводящей КИ Washington University School of Medicine
Страны USA
Фаза III
Кол-во пациентов 500
14.
Название протокола Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial
Дата начала и окончания КИ April 1, 2020 - December 31, 2020
Название организации, проводящей КИ Population Health Research Institute
Страны Canada
Фаза III
Кол-во пациентов 1500
15.
Название протокола A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam
Дата начала и окончания КИ April 1, 2020 - April 1, 2022
Название организации, проводящей КИ Oxford University Clinical Research Unit
Страны Vietnam
Фаза II
Кол-во пациентов 250
16.
Название протокола A questionnaire investigation of hydroxychloroquine for its potential protective effect against Severe Acute Respiratory Syndromes-coronavirus-2 infection
Дата начала и окончания КИ April 1, 2020 - June 30, 2020
Название организации, проводящей КИ The 2nd Xiangya Hospital of Central South Uinvercity
Страны China
Фаза -
Кол-во пациентов 1200
17.
Название протокола Chloroquine for Mild Symptomatic and Asymptomatic COVID-19 in A Two Staged, Multicenter, Open Label and Randomized Trial
Дата начала и окончания КИ April 2020 - December 2021
Название организации, проводящей КИ HaEmek Medical Center
Страны Israel
Фаза II-III
Кол-во пациентов 210
18.
Название протокола Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
Дата начала и окончания КИ April 2020 - April 2021
Название организации, проводящей КИ Columbia University
Страны USA
Фаза II
Кол-во пациентов 350
19.
Название протокола Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)
Дата начала и окончания КИ April 2020 - April 2021
Название организации, проводящей КИ University of Oxford
Страны Thailand
Кол-во пациентов 40000
20.
Название протокола An International, Multi-site, Bayesian Platform Adaptive,Randomised, Double-blind, Placebo-controlled Trial Assessing the Effectiveness of Varied Doses of Oral Chloroquine in Preventing or Reducing the Severity of COVID-19 Disease in Healthcare Workers
Дата начала и окончания КИ April 2020 - February 2021
Название организации, проводящей КИ Washington University School of Medicine
Страны Australia, Canada, Ireland, South Africa, United Kingdom, USA, Zambia
Фаза III
Кол-во пациентов 55000
21.
Название протокола A Prospective, Controlled, Randomized, Multicenter Study to Compare the Efficacy of a Chloroquine Analog (GNS561), an Anti PD-1 (Nivolumab) and an Anti-interleukine-6 Receptor (Tocilizumab) Versus Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection
Дата начала и окончания КИ April 2020 - August 2020
Название организации, проводящей КИ Centre Leon Berard
Страны France
Фаза II
Кол-во пациентов 273
22.
Название протокола Efficacy and Safety of Chloroquine Diphosphate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV2: a Phase IIb, Double-blind, Randomized Adaptive Clinical Trial
Дата начала и окончания КИ March 23, 2020 - August 31, 2020
Название организации, проводящей КИ Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Страны Brazil
Фаза IIb
Кол-во пациентов 440
23.
Название протокола Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ March 5, 2020 - June 23, 2020
Название организации, проводящей КИ Beijing Chao-yang Hospital, Capital Medical University
Страны China
Фаза II-III
Кол-во пациентов 150
24.
Название протокола Efficacy and safety of chloroquine phosphate inhalation combined with standard therapy in the treatment of novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ March 1, 2020 - June 30, 2020
Название организации, проводящей КИ Harbin infectious diseases hospital
Страны China
Кол-во пациентов 30
25.
Название протокола Single arm study for exploration of chloroquine phosphate aerosol inhalation in the treatment of novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 24, 2020 - May 31, 2020
Название организации, проводящей КИ The First Hospital of Jilin University
Страны China
Фаза IV
Кол-во пациентов 10
26.
Название протокола The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study
Дата начала и окончания КИ February 23, 2020 - February 28, 2021
Название организации, проводящей КИ Beijing YouAn Hospital
Страны China
Фаза IV
Кол-во пациентов 520
27.
Название протокола An open randomized controlled trial for Chloroquine phosphate and Hydroxychloroquine sulfate in the treatment of mild and common novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 22, 2020 - May 21, 2020
Название организации, проводящей КИ Zhongshan Hospital Affiliated to Xiamen University
Страны China
Кол-во пациентов 100
28.
Название протокола A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in mild/common patients with novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 20, 2020 - March 20, 2020
Название организации, проводящей КИ The Sixth Affiliated Hospital of Guangzhou Medical University (Qingyuan People's Hospital)
Страны China
Фаза IV
Кол-во пациентов 120
29.
Название протокола An open randomized controlled trial for Chloroquine phosphate and Hydroxychloroquine sulfate in the treatment of severe novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 17, 2020 - May 20, 2020
Название организации, проводящей КИ Zhongshan Hospital Affiliated to Xiamen University
Страны China
Фаза IV
Кол-во пациентов 100
30.
Название протокола Evaluation the Efficacy and Safety of Hydroxychloroquine Sulfate in Comparison with Phosphate Chloroquine in Mild and Commen Patients with Novel Coronavirus Pneumonia (COVID-19): a Randomized, Open-label, Parallel, Controlled Trial
Дата начала и окончания КИ February 17, 2020 - April 30, 2020
Название организации, проводящей КИ Peking University Third Hospital
Страны China
Фаза IV
Кол-во пациентов 100
31.
Название протокола A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in serious/critically ill patients with novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 17, 2020 - March 17, 2020
Название организации, проводящей КИ Jingzhou Central Hospital
Страны China
Фаза IV
Кол-во пациентов 45
32.
Название протокола A randomized, double-blind, parallel, controlled trial for comparison of phosphoric chloroquine combined with standard therapy and standard therapy in mild/common patients with novel coronavirus pneumon (COVID-19)ia
Дата начала и окончания КИ February 17, 2020 - March 17, 2020
Название организации, проводящей КИ Jingzhou Central Hospital
Страны China
Фаза IV
Кол-во пациентов 120
33.
Название протокола Clinical Study of Chloroquine Phosphate in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19)
Дата начала и окончания КИ February 13, 2020 - May 31, 2020
Название организации, проводящей КИ Zhongnan Hospital of Wuhan University
Страны China
Фаза IV
Кол-во пациентов 80
34.
Название протокола Efficacy of Chloroquine and Lopinavir/ Ritonavir in mild/general novel coronavirus (CoVID-19) infections: a prospective, open-label, multicenter randomized controlled clinical study
Дата начала и окончания КИ February 12, 2020 - December 31, 2020
Название организации, проводящей КИ The Fifth Affiliated Hospital Sun Yat-Sen University
Страны China
Фаза IV
Кол-во пациентов 112
35.
Название протокола Clinical Study of Chloroquine Phosphate in the Treatment of 2019-nCoV Infection
Дата начала и окончания КИ February 12, 2020 - May 30, 2020
Название организации, проводящей КИ Zhongnan Hospital of Wuhan University
Страны China
Фаза IV
Кол-во пациентов 80
36.
Название протокола A prospective, open-label, multiple-center study for the efficacy of chloroquine phosphate in hospitalized patients with novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 10, 2020 - December 31, 2020
Название организации, проводящей КИ The Fifth Affiliated Hospital of Sun Yat-Sen University
Страны China
Фаза IV
Кол-во пациентов 205
37.
Название протокола A Single-blind, Randomized, Controlled Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)
Дата начала и окончания КИ February 6, 2020 - February 6, 2021
Название организации, проводящей КИ HwaMei Hospital, University of Chinese Academy of Sciences
Страны China
Фаза -
Кол-во пациентов 100
38.
Название протокола A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)
Дата начала и окончания КИ February 6, 2020 - February 6, 2021
Название организации, проводящей КИ HwaMei Hospital, University of Chinese Academy of Sciences
Страны China
Фаза -
Кол-во пациентов 100
39.
Название протокола A prospective cohort study for the efficacy and safety of chloroquine in hospitalized patients with novel coronavirus pneumonia (COVID-19)
Дата начала и окончания КИ February 3, 2020 - June 30, 2020
Название организации, проводящей КИ Sun Yat sen Memorial Hospital of Sun Yat sen University
Страны China
Фаза IV
Кол-во пациентов 20
40.
Название протокола A multicenter, single-blind, randomized controlled clinical trial for chloroquine phosphate in the treatment of 2019 novel coronavirus-infected pneumonia
Дата начала и окончания КИ January 1, 2020 - April 30, 2020
Название организации, проводящей КИ Beijing you'an Hospital, Capital Medical University
Страны China
Фаза II
Кол-во пациентов 300