NCT05596617

Brief Summary

We performed a quasi-experimental open-label pragmatic study alternating standard of care (SOC) and oral bedtime melatonin (OBM) at different high doses over 4 consecutive time periods enrolling all consecutive RT-PCR SARS-CoV-2 severe Covid-19 admissions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 20, 2022

Last Update Submit

October 26, 2022

Conditions

Severe Covid-19

Keywords

Covid-19Adverse eventsOrgan dysfunctionMortality

Outcome Measures

Primary Outcomes (3)

  • Severe adverse events

    predefined severe adverse events

    From date of inclusion until date of hospital discharge or death

  • Organ dysfunction

    Sequential organ failure assessment score

    On days 1, 4, 7, 14 and 30 since first dose of melatonin

  • Mortality

    From date of inclusión to date of day 30 and day 90 mortality

    On days 30 and 90 since first dose of melatonin

Secondary Outcomes (1)

  • Length of stay

    Date of inclusion until date of ICU and hospital discharge or death

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of care management of severe Covid-19 patients

Oral bedtime melatonin

EXPERIMENTAL

Standard of care with oral bedtime melatonin

Drug: Oral bedtime melatonin

Interventions

Oral bedtime melatoninDRUG

Different doses of oral bedtime melatonin

Also known as: Standard of care
Oral bedtime melatonin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Positive RT-PCR for SARS-CoV-2

You may not qualify if:

  • Anticipated death within 48 hours or paliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jesus Fernandez-Tresguerres, MD.PhD

    Universidad Complutense Madrid

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: quasi-experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Critical Care

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 27, 2022

Study Start

April 22, 2020

Primary Completion

May 31, 2021

Study Completion

March 31, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Yes, although after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication
Access Criteria
Privision of an analysis plan

Locations

ES(1)