NCT05596617

Safety and Efficacy of Medications COVID-19

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Covid-19

Interventions

Type	Name	Description
DRUG	Oral bedtime melatonin	Different doses of oral bedtime melatonin

Timeline

• Start date: 2020-04-22
• Primary completion: 2021-05-31
• Completion: 2022-03-31
• First posted: 2022-10-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: Spain