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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
335
Different doses of oral bedtime melatonin
Hospital Clinico San Carlos
Madrid, Spain
Severe adverse events
predefined severe adverse events
Time frame: From date of inclusion until date of hospital discharge or death
Organ dysfunction
Sequential organ failure assessment score
Time frame: On days 1, 4, 7, 14 and 30 since first dose of melatonin
Mortality
From date of inclusión to date of day 30 and day 90 mortality
Time frame: On days 30 and 90 since first dose of melatonin
Length of stay
Length of ICU and hospital stay
Time frame: Date of inclusion until date of ICU and hospital discharge or death
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