NCT04568863 (MELCOVID) is a Phase 2 clinical trial of Melatonin intravenous in COVID-19, sponsored by Pharmamel S.L..

Who is sponsoring NCT04568863?

NCT04568863 is sponsored by Pharmamel S.L..

What drugs are being tested in NCT04568863?

Interventions in NCT04568863: Melatonin intravenous, Placebo intravenous.

What condition does NCT04568863 study?

NCT04568863 studies COVID-19, SARS-CoV 2, Coronavirus Infection.

Is NCT04568863 still recruiting?

NCT04568863 is currently completed. Last updated 18 March 2021.

Last reviewed 2021-03-18 · How we verify

NCT04568863: MELCOVID

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

Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19

Completed Phase 2 Last updated 18 March 2021

What this trial tests

Phase 2 trial testing Melatonin intravenous in COVID-19 in 18 participants. Completed in 30 November 2020.

Timeline

20 June 2020

Primary endpoint
30 November 2020

30 November 2020

Quick facts

Lead sponsor	Pharmamel S.L.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	20 June 2020
Primary completion	30 November 2020
Estimated completion	30 November 2020
Sites	1 location across Spain

Drugs / interventions tested

Melatonin intravenous — full drug profile →
Placebo intravenous

Conditions studied

COVID-19 — all drugs for COVID-19 →
SARS-CoV 2 — all drugs for SARS-CoV 2 →
Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Pharmamel S.L. — full company profile →

Who can join

18 and older, any sex, with COVID-19 or SARS-CoV 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

Publications & conference data

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

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
Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions.
Alam S, Sarker MMR, Afrin S, Richi FT, et al · · 2021 · cited 61× · PMID 34122096 · DOI 10.3389/fphar.2021.671498
Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
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
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
<i>In silico</i> investigation and potential therapeutic approaches of natural products for COVID-19: Computer-aided drug design perspective.
Rahman MM, Islam MR, Akash S, Mim SA, et al · · 2022 · cited 18× · PMID 36072227 · DOI 10.3389/fcimb.2022.929430
COVID-19 and pulmonary fibrosis: therapeutics in clinical trials, repurposing, and potential development.
Yim J, Lim HH, Kwon Y. · · 2021 · cited 16× · PMID 34047940 · DOI 10.1007/s12272-021-01331-9
Fighting cytokine storm and immunomodulatory deficiency: By using natural products therapy up to now.
Mohammed MA. · · 2023 · cited 15× · PMID 37124230 · DOI 10.3389/fphar.2023.1111329

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

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 NCT04568863 (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 Pharmamel S.L.
Last refreshed: 18 March 2021

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/NCT04568863.

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