Safety and Efficacy of Drugs Given Off-label for COVID-19
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 335
- Locations
- 1
- Primary Endpoint
- Severe adverse events
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive RT-PCR for SARS-CoV-2
Exclusion Criteria
- •Anticipated death within 48 hours or paliative care
Arms & Interventions
Oral bedtime melatonin
Standard of care with oral bedtime melatonin
Intervention: Oral bedtime melatonin (Drug)
Outcomes
Primary Outcomes
Severe adverse events
Time Frame: From date of inclusion until date of hospital discharge or death
predefined severe adverse events
Organ dysfunction
Time Frame: On days 1, 4, 7, 14 and 30 since first dose of melatonin
Sequential organ failure assessment score
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
- Length of stay(Date of inclusion until date of ICU and hospital discharge or death)
Investigators
Miguel Sanchez Garcia
Director Critical Care
Hospital San Carlos, Madrid