Covid19Phase 2NCT04470297
Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19
A Phase 2 study testing Ramelteon 8mg in people with Covid19 and Lung Injury, run by Associação Fundo de Incentivo à Pesquisa.
Trial summary
COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Lung Injury
- What is being tested?
- Ramelteon 8mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals (or legally authorized representative) providing written informed consent prior to initiation of any study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment
- Subject consents to randomization within 48 hours of hospital admission
- Symptom duration of 14 days or less upon recruitment
- At least one of the following:
- Radiographic infiltrates by imaging (chest x-ray or CT scan), OR
- Clinical assessment (evidence of rales/crackles on the exam) AND SpO2 ≤ 94% on room air
Who cannot join
- Mild COVID-19 disease (minor clinical symptoms, imaging does not show signs of lung inflammation)
- Recent history of or any in-hospital exposure to investigational medications targeting COVID-19
- ALT/AST > 5 times the upper limit of normal.
- Known hypersensitivity to ramelteon
- Pregnancy
- Severe hepatic insufficiency
- Fluvoxamine use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19
COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. The investigators proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.
Read the detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) pandemic, also denominated Coronavirus Disease 2019 (COVID-19), is currently challenging health systems in Brazil and worldwide. The mortality rate of confirmed cases of COVID-19 in Brazil seems to be close to twice that of countries like Germany and Canada. (1-3) The resulted viral interstitial pneumonia can lead to severe hypoxemic respiratory failure, overcrowded intensive care units (ICUs), shortages of equipment and personnel, and increased mortality. (4-6)
Some reasons for higher mortality risk in Brazil can be related to an increased propensity of clinical worsening in hospitalized patients. Consequently, reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with mild-to-moderate COVID-19 has become a priority to reduce the burden of such pandemic and the admission to ICUs. However, to our knowledge, few and complex specific interventions have been tested targeting outcomes related to a reduction of the immediate risk of severe disease and prolonged hospitalization in inpatients with mild-to-moderate clinical signs and symptoms.
Melatonin (N-acetyl-5-methoxytryptamine) is a hormone synthesized mainly by the pineal gland and also by other nonendocrine organs, including the immune system. Among its multiple properties, melatonin has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles exerted via both receptor-dependent and receptor-independent signalling cascades. (7,8) It has been suggested that melatonin receptors activation protects against organ injuries. (9-10). Additionally, melatonin receptors can mediate lower mortality rates after polymicrobial sepsis in animal models. (11)
Melatonin potentially modulates immune response by enhancing the secretion of anti-inflammatory cytokines including IL-10, which is involved in the Th2-like immune response. (12) IL-10 has effects on a myriad of cell types and, in lung cells under damaging circumstances, its production turns undermined. (13) Recent findings indicated that melatonin receptors are modulators of protective effects against acute lung injury induced by the ventilator in rats through the up-regulation of IL-10 production. (14) This evidence upsurged testing the effects of ramelteon, a potent and highly selective agonist of high-affinity melatonin receptors 1 (MT1) and MT2, which further displays antioxidative and anti-inflammatory properties. (15-17) Melatonin agonism may play a clinical role in individuals with acute lung injuries, including those induced by SARS-CoV-2 infection, which has not yet been investigated. The investigators designed a clinical trial testing standard care versus ramelteon 8mg under diverse clinical and laboratory outcomes related to the COVID-19 in hospitalized patients with this condition.
References
- Robert Koch Institut. Coronavirus Disease 2019 (COVID-19) Daily Situation Report of the Robert Koch Institute. Available from: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/Gesamt.html Updated 14.05.20
- DATASUS. Ministério da Saúde do Brasil. Available from: https://covid.saude.gov.br/. Atualizada em: 14/05/2020
- Government of Canada. Coronavirus Disease 2019 (COVID-19): Daily Epidemiology Update. Available from: https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection.html?topic=tilelink#a1. Updated 14.05.20.
- P.H.S. Pelicioni, S.R. Lord. COVID-19 will severely impact older people's lives, and in many more ways than you think!. Braz J Phys Ther, (2020), http://dx.doi.org/10.1016/j.bjpt.2020.04.005
- [3] R.D. Branson, D.R. Hess, L. Rubinson. SARS CoV-2: Guidance Document. American Association for Respiratory Care, (2020),
- World Health Organization. Coronavirus Disease 2019 (COVID-19) Situation Report 46. (2020)
- Jockers R, Delagrange P, Dubocovich ML, Markus RP, Renault N, Tosini G, Cecon E, Zlotos DP. Update on melatonin receptors: IUPHAR Review 20. Br J Pharmacol. 2016;173:2702-2725. doi: 10.1111/bph.13536.
- Radogna F, Paternoster L, Albertini MC, Cerella C, Accorsi A, Bucchini A, Spadoni G, Diamantini G, Tarzia G, De Nicola M, et al. Melatonin antagonizes apoptosis via receptor interaction in U937 monocytic cells. J Pineal Res. 2007;43:154-162. doi: 10.1111/j.1600-079X.2007.00455.x.
- Lochner A, Genade S, Davids A, Ytrehus K, Moolman JA. Short- and long-term effects of melatonin on myocardial post-ischemic recovery. J Pineal Res. 2006;40:56-63. doi: 10.1111/j.1600-079X.2005.00280.x.
- Rezzani R, Rodella LF, Bonomini F, Tengattini S, Bianchi R, Reiter RJ. Beneficial effects of melatonin in protecting against cyclosporine A-induced cardiotoxicity are receptor-mediated. J Pineal Res. 2006;41:288-295. doi: 10.1111/j.1600-079X.2006.00368.x.
- Fink T, Glas M, Wolf A, Kleber A, Reus E, Wolff M, Kiefer D, Wolf B, Rensing H, Volk T, Mathes AM. Melatonin receptors mediate improvements of survival in a model of polymicrobial sepsis. Crit Care Med. 2014;42:e22-e31. doi: 10.1097/CCM.0b013e3182a63e2b.
- Ren Wenkai, Liu Gang, Chen Shuai, Yin Jie, Wang Jing, Tan Bie, Wu Guoyao, Bazer Fuller W., Peng Yuanyi, Li Tiejun, Reiter Russel J., Yin Yulong. Melatonin signalling in T cells: Functions and applications. Journal of Pineal Research. 2017;62(3):e12394. doi: 10.1111/jpi.12394.
- Hokenson MA, Wang Y, Hawwa RL, Huang Z, Sharma S, Sanchez-Esteban J. Reduced IL-10 production in fetal type II epithelial cells exposed to mechanical stretch is mediated via activation of IL-6-SOCS3 signalling pathway. PLoS One. 2013;8:e59598. doi: 10.1371/journal.pone.0059598.
- Wu GC, Peng CK, Liao WI, Pao HP, Huang KL, Chu SJ. Melatonin receptor agonist protects against acute lung injury induced by ventilator through up-regulation of IL-10 production. Respir Res. 2020 Mar 6;21(1):65. doi: 10.1186/s12931-020-1325-2.
- Mathes AM, Kubulus D, Waibel L, Weiler J, Heymann P, Wolf B, Rensing H. Selective activation of melatonin receptors with ramelteon improves liver function and hepatic perfusion after hemorrhagic shock in the rat. Crit Care Med. 2008;36:2863-2870. doi: 10.1097/CCM.0b013e318187b863.
- Shimizu N, Nozawa M, Sugimoto K, Yamamoto Y, Minami T, Hayashi T, Yoshimura K, Ishii T, Uemura H. Therapeutic efficacy and anti-inflammatory effect of ramelteon in patients with insomnia associated with lower urinary tract symptoms. Res Rep Urol. 2013;5:113-119.
- Zhou W, Zhang X, Zhu CL, He ZY, Liang JP, Song ZC. Melatonin receptor agonists as the "Perioceutics" agents for the periodontal disease through modulation of Porphyromonas gingivalis virulence and inflammatory response. PLoS One. 2016;11:e0166442. doi: 10.1371/journal.pone.0166442
- Conditions
- Covid19, Lung Injury
- Being tested
- Ramelteon 8mg
- Keywords
- COVID-19, Acute Distress Respiratory Syndrome, Melatonin
- Medical subject headings
- COVID-19, Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon 8mgDrug
Standard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A placebo with the same physical characteristics of the experimental drug pill will be administered at the same time and daily schedule as the experimental intervention for 10 days. Receives: Drug: Ramelteon 8mg |
| Ramelteon | Experimental | A pill containing ramelteon 8mg will be administered daily at bedtime for 10 days. Receives: Drug: Ramelteon 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0]
Defined as a National Early Warning Score 2 (NEWS2) of 0 maintained for 24 hours [Time Frame: Assessed daily (enrollment is day 0)] The NEWS consists of a simple aggregate scoring system based on physiological measurements, regularly registered in inpatient settings, including six parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and temperature.
Measured: enrollment is day 0
Secondary outcomes (9)
Clinical worsening to critical COVID-19 illness
Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death
Measured: until Day 30
Duration of supplemental oxygen therapy
Measured by duration of use of supplemental oxygen (if applicable)
Measured: until day 14
Duration of mechanical ventilation (if applicable)
Measured by duration of use of mechanical ventilation
Measured: until day 30
Duration of hospitalisation
Measured by duration of hospitalization
Measured: until day 30
Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR
Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions
Measured: Day 14
C-reactive protein (CRP) level's reduction
Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission
Measured: Days 3, 5 and 8
Incidence of New Onset Lymphopenia
Incidence of new onset lymphopenia during hospitalization measured by blood draw
Measured: Through study completion, average of 15 days
Direct bilirubin level's reduction
Reduction of mean direct bilirubin levels in comparison with levels at the admission
Measured: Measured in study Days 3, 5, and 8
Side Effects
Differences in number of patients in study arms who experienced side effects
Measured: until day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronaldo Delmonte Piovezan, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Dalva Poyares, PhD, Study director, Associação Fundo de Incentivo a Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470297
- Sponsor's protocol ID
- MELCOV2020
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19
- ClinicalTrials.gov ID
- NCT04470297
- Acronym / sponsor ID
- MELCOV2020
- Conditions
- Covid19, Lung Injury
- Keywords
- COVID-19, Acute Distress Respiratory Syndrome, Melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. The investigators proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.
Detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) pandemic, also denominated Coronavirus Disease 2019 (COVID-19), is currently challenging health systems in Brazil and worldwide. The mortality rate of confirmed cases of COVID-19 in Brazil seems to be close to twice that of countries like Germany and Canada. (1-3) The resulted viral interstitial pneumonia can lead to severe hypoxemic respiratory failure, overcrowded intensive care units (ICUs), shortages of equipment and personnel, and increased mortality. (4-6)
Some reasons for higher mortality risk in Brazil can be related to an increased propensity of clinical worsening in hospitalized patients. Consequently, reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with mild-to-moderate COVID-19 has become a priority to reduce the burden of such pandemic and the admission to ICUs. However, to our knowledge, few and complex specific interventions have been tested targeting outcomes related to a reduction of the immediate risk of severe disease and prolonged hospitalization in inpatients with mild-to-moderate clinical signs and symptoms.
Melatonin (N-acetyl-5-methoxytryptamine) is a hormone synthesized mainly by the pineal gland and also by other nonendocrine organs, including the immune system. Among its multiple properties, melatonin has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles exerted via both receptor-dependent and receptor-independent signalling cascades. (7,8) It has been suggested that melatonin receptors activation protects against organ injuries. (9-10). Additionally, melatonin receptors can mediate lower mortality rates after polymicrobial sepsis in animal models. (11)
Melatonin potentially modulates immune response by enhancing the secretion of anti-inflammatory cytokines including IL-10, which is involved in the Th2-like immune response. (12) IL-10 has effects on a myriad of cell types and, in lung cells under damaging circumstances, its production turns undermined. (13) Recent findings indicated that melatonin receptors are modulators of protective effects against acute lung injury induced by the ventilator in rats through the up-regulation of IL-10 production. (14) This evidence upsurged testing the effects of ramelteon, a potent and highly selective agonist of high-affinity melatonin receptors 1 (MT1) and MT2, which further displays antioxidative and anti-inflammatory properties. (15-17) Melatonin agonism may play a clinical role in individuals with acute lung injuries, including those induced by SARS-CoV-2 infection, which has not yet been investigated. The investigators designed a clinical trial testing standard care versus ramelteon 8mg under diverse clinical and laboratory outcomes related to the COVID-19 in hospitalized patients with this condition.
References
- Robert Koch Institut. Coronavirus Disease 2019 (COVID-19) Daily Situation Report of the Robert Koch Institute. Available from: https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/Gesamt.html Updated 14.05.20
- DATASUS. Ministério da Saúde do Brasil. Available from: https://covid.saude.gov.br/. Atualizada em: 14/05/2020
- Government of Canada. Coronavirus Disease 2019 (COVID-19): Daily Epidemiology Update. Available from: https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection.html?topic=tilelink#a1. Updated 14.05.20.
- P.H.S. Pelicioni, S.R. Lord. COVID-19 will severely impact older people's lives, and in many more ways than you think!. Braz J Phys Ther, (2020), http://dx.doi.org/10.1016/j.bjpt.2020.04.005
- [3] R.D. Branson, D.R. Hess, L. Rubinson. SARS CoV-2: Guidance Document. American Association for Respiratory Care, (2020),
- World Health Organization. Coronavirus Disease 2019 (COVID-19) Situation Report 46. (2020)
- Jockers R, Delagrange P, Dubocovich ML, Markus RP, Renault N, Tosini G, Cecon E, Zlotos DP. Update on melatonin receptors: IUPHAR Review 20. Br J Pharmacol. 2016;173:2702-2725. doi: 10.1111/bph.13536.
- Radogna F, Paternoster L, Albertini MC, Cerella C, Accorsi A, Bucchini A, Spadoni G, Diamantini G, Tarzia G, De Nicola M, et al. Melatonin antagonizes apoptosis via receptor interaction in U937 monocytic cells. J Pineal Res. 2007;43:154-162. doi: 10.1111/j.1600-079X.2007.00455.x.
- Lochner A, Genade S, Davids A, Ytrehus K, Moolman JA. Short- and long-term effects of melatonin on myocardial post-ischemic recovery. J Pineal Res. 2006;40:56-63. doi: 10.1111/j.1600-079X.2005.00280.x.
- Rezzani R, Rodella LF, Bonomini F, Tengattini S, Bianchi R, Reiter RJ. Beneficial effects of melatonin in protecting against cyclosporine A-induced cardiotoxicity are receptor-mediated. J Pineal Res. 2006;41:288-295. doi: 10.1111/j.1600-079X.2006.00368.x.
- Fink T, Glas M, Wolf A, Kleber A, Reus E, Wolff M, Kiefer D, Wolf B, Rensing H, Volk T, Mathes AM. Melatonin receptors mediate improvements of survival in a model of polymicrobial sepsis. Crit Care Med. 2014;42:e22-e31. doi: 10.1097/CCM.0b013e3182a63e2b.
- Ren Wenkai, Liu Gang, Chen Shuai, Yin Jie, Wang Jing, Tan Bie, Wu Guoyao, Bazer Fuller W., Peng Yuanyi, Li Tiejun, Reiter Russel J., Yin Yulong. Melatonin signalling in T cells: Functions and applications. Journal of Pineal Research. 2017;62(3):e12394. doi: 10.1111/jpi.12394.
- Hokenson MA, Wang Y, Hawwa RL, Huang Z, Sharma S, Sanchez-Esteban J. Reduced IL-10 production in fetal type II epithelial cells exposed to mechanical stretch is mediated via activation of IL-6-SOCS3 signalling pathway. PLoS One. 2013;8:e59598. doi: 10.1371/journal.pone.0059598.
- Wu GC, Peng CK, Liao WI, Pao HP, Huang KL, Chu SJ. Melatonin receptor agonist protects against acute lung injury induced by ventilator through up-regulation of IL-10 production. Respir Res. 2020 Mar 6;21(1):65. doi: 10.1186/s12931-020-1325-2.
- Mathes AM, Kubulus D, Waibel L, Weiler J, Heymann P, Wolf B, Rensing H. Selective activation of melatonin receptors with ramelteon improves liver function and hepatic perfusion after hemorrhagic shock in the rat. Crit Care Med. 2008;36:2863-2870. doi: 10.1097/CCM.0b013e318187b863.
- Shimizu N, Nozawa M, Sugimoto K, Yamamoto Y, Minami T, Hayashi T, Yoshimura K, Ishii T, Uemura H. Therapeutic efficacy and anti-inflammatory effect of ramelteon in patients with insomnia associated with lower urinary tract symptoms. Res Rep Urol. 2013;5:113-119.
- Zhou W, Zhang X, Zhu CL, He ZY, Liang JP, Song ZC. Melatonin receptor agonists as the "Perioceutics" agents for the periodontal disease through modulation of Porphyromonas gingivalis virulence and inflammatory response. PLoS One. 2016;11:e0166442. doi: 10.1371/journal.pone.0166442
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Ramelteon 8mgA placebo with the same physical characteristics of the experimental drug pill will be administered at the same time and daily schedule as the experimental intervention for 10 days. |
| Ramelteon | Experimental | Drug: Ramelteon 8mgA pill containing ramelteon 8mg will be administered daily at bedtime for 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals (or legally authorized representative) providing written informed consent prior to initiation of any study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment
- Subject consents to randomization within 48 hours of hospital admission
- Symptom duration of 14 days or less upon recruitment
- At least one of the following:
Key exclusion criteria (7 listed)
- Mild COVID-19 disease (minor clinical symptoms, imaging does not show signs of lung inflammation)
- Recent history of or any in-hospital exposure to investigational medications targeting COVID-19
- ALT/AST > 5 times the upper limit of normal.
- Known hypersensitivity to ramelteon
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramelteon 8mgStandard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days | Drug | Placebo, Ramelteon |
Primary outcome
Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0]
Time frame: enrollment is day 0
Defined as a National Early Warning Score 2 (NEWS2) of 0 maintained for 24 hours [Time Frame: Assessed daily (enrollment is day 0)] The NEWS consists of a simple aggregate scoring system based on physiological measurements, regularly registered in inpatient settings, including six parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and temperature.
9 secondary outcomes
Clinical worsening to critical COVID-19 illness
Time frame: until Day 30
Duration of supplemental oxygen therapy
Time frame: until day 14
Duration of mechanical ventilation (if applicable)
Time frame: until day 30
Duration of hospitalisation
Time frame: until day 30
Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR
Time frame: Day 14
C-reactive protein (CRP) level's reduction
Time frame: Days 3, 5 and 8
Incidence of New Onset Lymphopenia
Time frame: Through study completion, average of 15 days
Direct bilirubin level's reduction
Time frame: Measured in study Days 3, 5, and 8
Side Effects
Time frame: until day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalva Poyares, PhD study director
Associação Fundo de Incentivo a Pesquisa
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramelteon 8mg in people with Covid19 and Lung Injury, run by Associação Fundo de Incentivo à Pesquisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronaldo D Piovezan, PhD (+5511984153364, rdpiovezan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0] (time frame: enrollment is day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.