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

Summary

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.

Timeline

Start

2026-02

Primary completion

2027-06

Completion

2027-12

Publications

• Results 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):4750-4765. doi: 10.1111/bph.17322. Epub 2024 Aug 19.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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 Mar 5.
• Results Dengue Alliance. Electronic address: [email protected]; 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.
• Results 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):2177-2186. doi: 10.1056/NEJMoa2030243.
• Results Schilling WHK, Jittamala P, Watson JA, Boyd S, Luvira V, Siripoon T, Ngamprasertchai T, Batty EM, Cruz C, Callery JJ, Singh S, Saroj M, Kruabkontho V, Ngernseng T, Tanglakmankhong N, Tubprasert J, Abdad MY, Madmanee W, Kouhathong J, Suwannasin K, Pagornrat W, Piaraksa N, Hanboonkunupakarn P, Hanboonkunupakarn B, Poovorawan K, Potaporn M, Srisubat A, Loharjun B, Taylor WRJ, Chotivanich V, Chotivanich K, Imwong M, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Antiviral efficacy of molnupiravir versus ritonavir-boosted nirmatrelvir in patients with early symptomatic COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial. Lancet Infect Dis. 2024 Jan;24(1):36-45. doi: 10.1016/S1473-3099(23)00493-0. Epub 2023 Sep 28.
• Results Jittamala P, Schilling WHK, Watson JA, Luvira V, Siripoon T, Ngamprasertchai T, Almeida PJ, Ekkapongpisit M, Cruz C, Callery JJ, Boyd S, Anunsittichai O, Hongsuwan M, Singhaboot Y, Pagornrat W, Tuntipaiboontana R, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Keayarsa S, Madmanee W, Aguiar RS, Santos FM, Batty EM, Hanboonkunupakarn P, Hanboonkunupakarn B, Sookprome S, Poovorawan K, Imwong M, Taylor WRJ, Chotivanich V, Sangketchon C, Ruksakul W, Chotivanich K, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Clinical Antiviral Efficacy of Remdesivir in Coronavirus Disease 2019: An Open-Label, Randomized Controlled Adaptive Platform Trial (PLATCOV). J Infect Dis. 2023 Nov 11;228(10):1318-1325. doi: 10.1093/infdis/jiad275.
• Results Butler CC, Hobbs FDR, Gbinigie OA, Rahman NM, Hayward G, Richards DB, Dorward J, Lowe DM, Standing JF, Breuer J, Khoo S, Petrou S, Hood K, Nguyen-Van-Tam JS, Patel MG, Saville BR, Marion J, Ogburn E, Allen J, Rutter H, Francis N, Thomas NPB, Evans P, Dobson M, Madden TA, Holmes J, Harris V, Png ME, Lown M, van Hecke O, Detry MA, Saunders CT, Fitzgerald M, Berry NS, Mwandigha L, Galal U, Mort S, Jani BD, Hart ND, Ahmed H, Butler D, McKenna M, Chalk J, Lavallee L, Hadley E, Cureton L, Benysek M, Andersson M, Coates M, Barrett S, Bateman C, Davies JC, Raymundo-Wood I, Ustianowski A, Carson-Stevens A, Yu LM, Little P; PANORAMIC Trial Collaborative Group. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. 2023 Jan 28;401(10373):281-293. doi: 10.1016/S0140-6736(22)02597-1. Epub 2022 Dec 22.
• Results Schilling WHK, Jittamala P, Watson JA, Ekkapongpisit M, Siripoon T, Ngamprasertchai T, Luvira V, Pongwilai S, Cruz C, Callery JJ, Boyd S, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Piaraksa N, Suwannasin K, Hanboonkunupakarn P, Hanboonkunupakarn B, Sookprome S, Poovorawan K, Thaipadungpanit J, Blacksell S, Imwong M, Tarning J, Taylor WRJ, Chotivanich V, Sangketchon C, Ruksakul W, Chotivanich K, Teixeira MM, Pukrittayakamee S, Dondorp AM, Day NPJ, Piyaphanee W, Phumratanaprapin W, White NJ; PLATCOV Collaborative Group. Pharmacometrics of high-dose ivermectin in early COVID-19 from an open label, randomized, controlled adaptive platform trial (PLATCOV). Elife. 2023 Feb 21;12:e83201. doi: 10.7554/eLife.83201.
• Results Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.
• Results Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Adams AC, Van Naarden J, Custer KL, Shen L, Durante M, Oakley G, Schade AE, Sabo J, Patel DR, Klekotka P, Skovronsky DM; BLAZE-1 Investigators. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):229-237. doi: 10.1056/NEJMoa2029849. Epub 2020 Oct 28.
• Results Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, Musser BJ, Soo Y, Rofail D, Im J, Perry C, Pan C, Hosain R, Mahmood A, Davis JD, Turner KC, Hooper AT, Hamilton JD, Baum A, Kyratsous CA, Kim Y, Cook A, Kampman W, Kohli A, Sachdeva Y, Graber X, Kowal B, DiCioccio T, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD; Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. doi: 10.1056/NEJMoa2035002. Epub 2020 Dec 17.
• Results Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, Oguchi G, Ryan P, Nielsen BU, Brown M, Hidalgo A, Sachdeva Y, Mittal S, Osiyemi O, Skarbinski J, Juneja K, Hyland RH, Osinusi A, Chen S, Camus G, Abdelghany M, Davies S, Behenna-Renton N, Duff F, Marty FM, Katz MJ, Ginde AA, Brown SM, Schiffer JT, Hill JA; GS-US-540-9012 (PINETREE) Investigators. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. doi: 10.1056/NEJMoa2116846. Epub 2021 Dec 22.

Drugs

Indications