Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)

Официальное название

A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection

Обзор

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are: Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.

Вмешательства

• Препарат Resomelagon
  Resomelagon 100mg, orally, once daily.
• Препарат Placebo
  Placebo
• Другое Standard Treatment
  Hydration and symptomatic therapy as indicated for Dengue fever.

Первичные конечные точки

• Evaluate safety of Resomelagon in Dengue patients [Срок оценки: 28 days]
• Efficacy of Resomelagon in decreasing illness duration [Срок оценки: 10 days]

Вторичные конечные точки (3)

• Efficacy of Resomelagon in reducing illness Severity [Срок оценки: 10 days]
• Efficacy of Resomelagon in reducing plasma leakage [Срок оценки: 10 days]
• Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department [Срок оценки: 10 days]

Критерии участия

Критерии включения

• Patients who are 18 to 65 years old;
• Able to understand study procedures and give informed consent;
• Presents with more than 36 and less than 84h since symptoms onset;
• Symptoms compatible with dengue infection (fever, myalgia, arthralgia, headache or conjunctivitis) with positive antigen test or polymerase chain reaction test.

Критерии исключения

• Has any comorbidity which is perceived as significant by the investigator;
• Significant laboratory abnormalities discovered at triage: Hemoglobin <10g/dL; Platelet count < 50.000/microL; alanine transaminase > 3x upper limit of normal; Total bilirubin >1,5 x upper limit of normal; glomerular filtration rate < 60mls/min/1,73m2;
• Contraindications or known hypersensitivity to Resomelagon;
• Presents as dengue with warning signs or severe dengue at inclusion;
• Currently participating in another drug clinical trial;
• Clinical evidence of another infection that might explain current symptoms;
• Pregnant women or women actively trying to achieve pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Clinical Research Unit — Belo Horizonte
• Centro Integrado de Pesquisa — São José do Rio Preto

Публикации

• Almeida PRJ, Periard AM, Tana FL, Avila RE, Milhorato LB, Alcantara KMM, Resende CB, Serufo AV, Santos FR, Teixeira DC, Queiroz-Junior CM, Fonseca TCM, Silva BLV, Costa VV, Souza RP, Perretti M, Jonassen TEN, Teixeira MM. Effects of a pro-resolving drug in COVID-19: preclinical studies to a randomized, placebo-controlled, phase Ib/IIa trial in hospitalized patients. Br J Pharmacol. 2024 Dec;181(23 PMID 39159951
• Ehteshami M, Tao S, Zandi K, Hsiao HM, Jiang Y, Hammond E, Amblard F, Russell OO, Merits A, Schinazi RF. Characterization of beta-d-N4-Hydroxycytidine as a Novel Inhibitor of Chikungunya Virus. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02395-16. doi: 10.1128/AAC.02395-16. Print 2017 Apr. PMID 28137799
• An YJ, Choi SM, Choi ER, Nam YE, Seo EW, Ahn SB, Jang Y, Kim M, Cho JH. Synthesis and biological evaluation of new beta-D-N4-hydroxycytidine analogs against SARS-CoV-2, influenza viruses and DENV-2. Bioorg Med Chem Lett. 2023 Mar 1;83:129174. doi: 10.1016/j.bmcl.2023.129174. Epub 2023 Feb 8. PMID 36764470
• Imran M, Kumar Arora M, Asdaq SMB, Khan SA, Alaqel SI, Alshammari MK, Alshehri MM, Alshrari AS, Mateq Ali A, Al-Shammeri AM, Alhazmi BD, Harshan AA, Alam MT, Abida. Discovery, Development, and Patent Trends on Molnupiravir: A Prospective Oral Treatment for COVID-19. Molecules. 2021 Sep 24;26(19):5795. doi: 10.3390/molecules26195795. PMID 34641339
• Singh AK, Singh A, Singh R, Misra A. Molnupiravir in COVID-19: A systematic review of literature. Diabetes Metab Syndr. 2021 Nov-Dec;15(6):102329. doi: 10.1016/j.dsx.2021.102329. Epub 2021 Oct 30. PMID 34742052
• Silva MMO, Kikuti M, Anjos RO, Portilho MM, Santos VC, Goncalves TSF, Tauro LB, Moreira PSS, Jacob-Nascimento LC, Santana PM, Campos GS, Siqueira AM, Kitron U, Reis MG, Ribeiro GS. Risk of chronic arthralgia and impact of pain on daily activities in a cohort of patients with chikungunya virus infection from Brazil. Int J Infect Dis. 2021 Apr;105:608-616. doi: 10.1016/j.ijid.2021.03.003. Epub 2021 PMID 33684559
• Dengue Alliance. Electronic address: gnmalavige@dndi.org; Dengue Alliance. Treatments for dengue: a Global Dengue Alliance to address unmet needs. Lancet Glob Health. 2023 Nov;11(11):e1680-e1681. doi: 10.1016/S2214-109X(23)00362-5. Epub 2023 Aug 31. No abstract available. PMID 37660714
• Utarini A, Indriani C, Ahmad RA, Tantowijoyo W, Arguni E, Ansari MR, Supriyati E, Wardana DS, Meitika Y, Ernesia I, Nurhayati I, Prabowo E, Andari B, Green BR, Hodgson L, Cutcher Z, Rances E, Ryan PA, O'Neill SL, Dufault SM, Tanamas SK, Jewell NP, Anders KL, Simmons CP; AWED Study Group. Efficacy of Wolbachia-Infected Mosquito Deployments for the Control of Dengue. N Engl J Med. 2021 Jun 10;384(23 PMID 34107180

Идентификаторы

NCT: NCT06917001 · 85788125.5.1001.5415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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