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Completed

NCT Number: NCT05596617

Safety and Efficacy of Medications 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.

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Key information

Conditions

Severe Covid-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive RT-PCR for SARS-CoV-2

Exclusion criteria

  • Anticipated death within 48 hours or paliative care

Treatment and study plan

Oral bedtime melatonin

Drug

Different doses of oral bedtime melatonin

Other names: Standard of care

Primary outcomes

  1. Severe adverse events

    Time frame: From date of inclusion until date of hospital discharge or death

    predefined severe adverse events

  2. Organ dysfunction

    Time frame: On days 1, 4, 7, 14 and 30 since first dose of melatonin

    Sequential organ failure assessment score

  3. 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

Secondary outcomes

  1. Length of stay

    Time frame: Date of inclusion until date of ICU and hospital discharge or death

    Length of ICU and hospital stay

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 27, 2022
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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