Safety and Efficacy of Medications COVID-19

Severe Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596617
• Other study ID #: Meds Off-label
• Status: Completed
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2022
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: March 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

• Anticipated death within 48 hours or paliative care

Related Conditions & MeSH terms

• COVID-19
• Severe Covid-19

Intervention

Drug:
• Oral bedtime melatonin
Different doses of oral bedtime melatonin

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe adverse events	predefined severe adverse events	From date of inclusion until date of hospital discharge or death
Primary	Organ dysfunction	Sequential organ failure assessment score	On days 1, 4, 7, 14 and 30 since first dose of melatonin
Primary	Mortality	From date of inclusión to date of day 30 and day 90 mortality	On days 30 and 90 since first dose of melatonin
Secondary	Length of stay	Length of ICU and hospital stay	Date of inclusion until date of ICU and hospital discharge or death