Dengue FeverPhase 2RESOVIR-2NCT06917001
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
A Phase 2 study testing Resomelagon and Standard Treatment in people with Dengue Fever, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dengue Fever
- What is being tested?
- Resomelagon and Standard Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Mar 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Clinical Research Unit
Belo Horizonte, Minas Gerais, 30750140
Pedro RJ Almeida, MD MSc, +5531995166160, pedrojesus@ufmg.br
- Not yet recruiting
Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo, 15090000
Cassia F Estofolete, MD PhD, +5517981163147, cassiaestofolete@gmail.com
Cassia F Estofolete, MD PhD
About this study
Official title: A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection
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.
Read the detailed description
Complications of dengue infection follows the peak of viremia and are associated with increased activation of the immune response. Proof-of-concept studies in animal models of dengue infection have shown that blocking certain aspects of the inflammatory response or the administration of pro-resolving molecules is beneficial in experimental dengue. In these experiments, the administration of certain anti-inflammatory or pro-resolution molecules decreases disease severity and aspects of the inflammatory response, including changes in vascular permeability. We have previously shown that treatment with RESOMELAGON decreased lung inflammation and outcome in animal models of beta coronavirus infection (including by SARS-CoV-2) and decreased disease severity in COVID-19 patients, even in the presence of glucocorticoid therapy. Preclinical experiments also showed that RESOMELAGON decreased disease severity in an animal model of dengue infection and decreased cytokine release by human PBMC infected with dengue virus. RESOMELAGON is safe in healthy individuals, those with rheumatoid arthritis, and patients with COVID-19. This is a placebo controlled, randomized, double-blinded clinical trial evaluating the safety and efficacy of Resomelagon in patients with acute dengue infection.
- Conditions
- Dengue Fever
- Being tested
- Resomelagon, Placebo, Standard Treatment
- Keywords
- Resomelagon, Resolution of inflammation, Melanocortin, Dengue, RESOVIR-2
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResomelagonDrug
Resomelagon 100mg, orally, once daily.
PlaceboDrug
Placebo
Standard TreatmentOther
Hydration and symptomatic therapy as indicated for Dengue fever.
| Study group | Role | What they receive |
|---|---|---|
| Resomelagon | Experimental | Resomelagon, 100mg, orally, once daily plus standard treatment Receives: Drug: Resomelagon; Other: Standard Treatment |
| Placebo | Placebo comparator | Placebo plus standard treatment Receives: Drug: Placebo; Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of Resomelagon in Dengue patients
Incidence of clinical or laboratory adverse events. All symptoms, illness and laboratory abnormalities will be graded by the investigators in accordance to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events graded 3 or more in severity will be registered. Serious adverse events will be reported and registered. Incidence of adverse events will be compared between placebo and intervention groups.
Measured: 28 days
Efficacy of Resomelagon in decreasing illness duration
Time to resolution of illness as defined by a composite outcome:
Patient afebrile for 48 hours without paracetamol (or other drugs to treat fever) ingestion; Rising platelet counts of >20% of the lowest, or normal platelet counts if the patient did not have thrombocytopenia, following two consecutive measurements from the lowest platelet count Haematocrit stabilized or return to the normal hematocrit for age \& sex, following two consecutive measurements Absence of bleeding or significant vomiting for 48h.
Measured: 10 days
Secondary outcomes (3)
Efficacy of Resomelagon in reducing illness Severity
Incidence of dengue with warning signs or severe dengue in the study patients
Measured: 10 days
Efficacy of Resomelagon in reducing plasma leakage
Incidence of hemoconcentration (hematocrit increase of >10% from inclusion or elevated for age \& sex) OR evidence of pleural effusion OR evidence of ascitis OR pericardial effusion
Measured: 10 days
Efficacy of Resomelagon in reducing dengue hospitalization or prolonged observation in the Emergency department
Incidence of a stay of more than 12h in the emergency department or hospital admission
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciência e Tecnologia em Dengue (INCT em Dengue)
- Responsible party
- Principal investigator, Mauro Martins Teixeira, Federal University of Minas Gerais
- Investigators
- Mauro M Teixeira, MD PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917001
- Sponsor's protocol ID
- 85788125.5.1001.5415
- Acronym
- RESOVIR-2
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39159951Ehteshami 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.
PubMed 28137799An 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.
PubMed 36764470Imran 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.
PubMed 34641339Singh 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.
PubMed 34742052Silva 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.
PubMed 33684559Dengue 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.
PubMed 37660714Utarini 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.
PubMed 34107180Schilling 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.
PubMed 37778363Jittamala 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.
PubMed 37470445Butler 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.
PubMed 36566761Schilling 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.
PubMed 36803992Hammond 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.
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