NCT04470297 is a Phase 2 clinical trial of Ramelteon 8mg in Covid19, sponsored by Associação Fundo de Incentivo à Pesquisa.

Who is sponsoring NCT04470297?

NCT04470297 is sponsored by Associação Fundo de Incentivo à Pesquisa.

What drugs are being tested in NCT04470297?

Interventions in NCT04470297: Ramelteon 8mg.

What condition does NCT04470297 study?

NCT04470297 studies Covid19, Lung Injury.

Is NCT04470297 still recruiting?

NCT04470297 is currently status unknown. Last updated 22 July 2020.

Last reviewed 2020-07-22 · How we verify

NCT04470297

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Adjuvant Therapeutic Effects of Melatonin Agonist on Hospitalized Patients With Confirmed or Suspected COVID-19

Status unknown Phase 2 Last updated 22 July 2020

What this trial tests

Phase 2 trial testing Ramelteon 8mg in Covid19 in 100 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 November 2020

1 March 2021

Quick facts

Lead sponsor	Associação Fundo de Incentivo à Pesquisa
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	1 September 2020
Primary completion	1 November 2020
Estimated completion	1 March 2021

Drugs / interventions tested

Ramelteon 8mg — full drug profile →

Conditions studied

Covid19 — all drugs for Covid19 →
Lung Injury — all drugs for Lung Injury →

Sponsor

Associação Fundo de Incentivo à Pesquisa — full company profile →

Who can join

Adults 18 to 80, any sex, with Covid19 or Lung Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Oxidative Stress and Inflammation in COVID-19-Associated Sepsis: The Potential Role of Anti-Oxidant Therapy in Avoiding Disease Progression.
Beltrán-García J, Osca-Verdegal R, Pallardó FV, Ferreres J, et al · · 2020 · cited 103× · PMID 33003552 · DOI 10.3390/antiox9100936
Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
Therapeutic potential of melatonin and melatonergic drugs on K18-hACE2 mice infected with SARS-CoV-2.
Cecon E, Izabelle C, Poder SL, Real F, et al · · 2022 · cited 28× · PMID 34586649 · DOI 10.1111/jpi.12772
SARS-CoV-2: Immune Response Elicited by Infection and Development of Vaccines and Treatments.
Canedo-Marroquín G, Saavedra F, Andrade CA, Berrios RV, et al · · 2020 · cited 27× · PMID 33362758 · DOI 10.3389/fimmu.2020.569760
Melatonin for the Early Treatment of COVID-19: A Narrative Review of Current Evidence and Possible Efficacy.
Cross KM, Landis DM, Sehgal L, Payne JD. · · 2021 · cited 22× · PMID 34119679 · DOI 10.1016/j.eprac.2021.06.001
Pineal hormone melatonin as an adjuvant treatment for COVID‑19 (Review).
Vlachou M, Siamidi A, Dedeloudi A, Konstantinidou SK, et al · · 2021 · cited 19× · PMID 33576451 · DOI 10.3892/ijmm.2021.4880
The role of reactive oxygen species in severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection-induced cell death.
Xie J, Yuan C, Yang S, Ma Z, et al · · 2024 · cited 14× · PMID 39516736 · DOI 10.1186/s11658-024-00659-6
Potential and Possible Therapeutic Effects of Melatonin on SARS-CoV-2 Infection.
Shchetinin E, Baturin V, Arushanyan E, Bolatchiev A, et al · · 2022 · cited 6× · PMID 35052644 · DOI 10.3390/antiox11010140

Verify or expand the search:

Other trials of Ramelteon 8mg

Trials testing the same drug.

NCT03461042 — The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) a · Phase 4 · completed

Other recruiting trials for Covid19

Currently open trials in the same condition.

NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation · NA · recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting

Other Associação Fundo de Incentivo à Pesquisa trials

Trials by the same sponsor.

NCT07382206 — Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group · NA · recruiting
NCT03299257 — Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea · Phase 4 · unknown
NCT04872816 — Obstructive Sleep Apnea and Telomere Length · Phase 2 · completed
NCT03212209 — Comparison of CPAP Modalities for OSA Treatment · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04470297 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Associação Fundo de Incentivo à Pesquisa
Last refreshed: 22 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04470297.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing