Safety and Efficacy of Medications COVID-19

Not Applicable

Completed

• Conditions: Severe Covid-19
• Interventions: Drug: Oral bedtime melatonin

• Registration Number: NCT05596617
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Study Timeline

• Study Start: 2020-04-22
• Primary Completion: 2021-05-31
• Study Completion: 2022-03-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Positive RT-PCR for SARS-CoV-2

Exclusion Criteria

• Anticipated death within 48 hours or paliative care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Oral bedtime melatonin	Oral bedtime melatonin	Standard of care with oral bedtime melatonin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Length of stay	Date of inclusion until date of ICU and hospital discharge or death	Length of ICU and hospital stay

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain