Severe Covid-19
Conditions
Keywords
Covid-19, Adverse events, Organ dysfunction, Mortality
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.
Interventions
Different doses of oral bedtime melatonin
Sponsors
Hospital San Carlos, Madrid
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
quasi-experimental
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Positive RT-PCR for SARS-CoV-2
Exclusion criteria
* Anticipated death within 48 hours or paliative care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse events | From date of inclusion until date of hospital discharge or death | predefined severe adverse events |
| Organ dysfunction | On days 1, 4, 7, 14 and 30 since first dose of melatonin | Sequential organ failure assessment score |
| Mortality | On days 30 and 90 since first dose of melatonin | From date of inclusión to date of day 30 and day 90 mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Date of inclusion until date of ICU and hospital discharge or death | Length of ICU and hospital stay |
Countries
Spain
Outcome results
None listed