Safety and Efficacy of Medications COVID-19 | NCT05596617

Studies
Safety and Efficacy of Medications COVID-19

NCT05596617

Sponsor

Hospital San Carlos, Madrid

Status

Completed

Last Update Posted

Oct 27, 2022Actual

Enrollment

335Actual

Phase

Not Applicable

Conditions

Severe Covid-19

Interventions

Oral bedtime melatonin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2020Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Oct 20, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2022

Last Update Posted Date

Oct 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Miguel Sanchez Garcia, Director Critical Care, Hospital San Carlos, MadridPrincipal Investigator

Lead Sponsor

Hospital San Carlos, MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The 4 successive study time periods spanned from March 2020 to April 2021 and included: 1) standard of care (SOC) (C1), 2) SOC + oral bedtime melatonin (OBM) (T1), 3) SOC (C2), and 4) SOC + OBM (T2). During T1, 3 consecutive subgroups received 50 mg, 100 mg and 200 mg OBM. During T2, 100 mg OBM was given. Melatonin was administered from ICU admission to hospital discharge or death.

The main objectives were occurrence of predefined severe adverse events (SAEs), Sequential Organ Failure Assessment (SOFA) scores and day-30 (D30) and 90 (D90) mortality. Study subjects were followed for modified Rankin scale (mRS) at 30 days after the last OBM dose or hospital discharge.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

335Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oral bedtime melatonin	Drug	Different doses of oral bedtime melatonin	Oral bedtime melatonin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Length of stay	Length of ICU and hospital stay	Date of inclusion until date of ICU and hospital discharge or death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

Anticipated death within 48 hours or paliative care

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesus Fernandez-Tresguerres, MD.PhD	Universidad Complutense Madrid	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Yes, although after publication

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

After publication

Access Criteria

Privision of an analysis plan

URL

Not provided

Type	Date	Date Unknown
Release	Jun 19, 2023
Reset	Feb 15, 2024
Release	May 23, 2024
Reset	Sep 26, 2024

Submission Tracking

Estimated Results First Submitted Date

Jun 19, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 19, 2023			Feb 15, 2024
May 23, 2024

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided