Safety and Efficacy of Medications COVID-19

Sponsor

Hospital San Carlos, Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT05596617

Collaborator

(none)

335

Enrollment

Location

Arms

23.3

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Covid-19	Drug: Oral bedtime melatonin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

335 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

quasi-experimentalquasi-experimental

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 22, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay [Date of inclusion until date of ICU and hospital discharge or death]
Length of ICU and hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

Anticipated death within 48 hours or paliative care

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico San Carlos	Madrid		Spain	28040

Sponsors and Collaborators

Hospital San Carlos, Madrid

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Miguel Sanchez Garcia, Director Critical Care, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT05596617

Other Study ID Numbers:

Meds Off-label

First Posted:

Oct 27, 2022

Last Update Posted:

Oct 27, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Miguel Sanchez Garcia, Director Critical Care, Hospital San Carlos, Madrid

Additional relevant MeSH terms:

COVID-19

Melatonin

Study Results

No Results Posted as of Oct 27, 2022