Safety and Efficacy of Medications COVID-19

October 26, 2022 updated by: Miguel Sanchez Garcia, Hospital San Carlos, Madrid

Safety and Efficacy of Drugs Given Off-label for COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

  • Anticipated death within 48 hours or paliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Standard of care management of severe Covid-19 patients
Experimental: Oral bedtime melatonin
Standard of care with oral bedtime melatonin
Drug: Oral bedtime melatonin
Different doses of oral bedtime melatonin
Other Names:
  • Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe adverse events
Time Frame: From date of inclusion until date of hospital discharge or death
predefined severe adverse events
From date of inclusion until date of hospital discharge or death
Organ dysfunction
Time Frame: On days 1, 4, 7, 14 and 30 since first dose of melatonin
Sequential organ failure assessment score
On days 1, 4, 7, 14 and 30 since first dose of melatonin
Mortality
Time Frame: On days 30 and 90 since first dose of melatonin
From date of inclusión to date of day 30 and day 90 mortality
On days 30 and 90 since first dose of melatonin

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Investigators

  • Study Chair: Jesus Fernandez-Tresguerres, MD.PhD, Universidad Complutense Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meds Off-label

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Yes, although after publication

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Privision of an analysis plan

IPD Sharing Supporting Information Type

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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