Safety and Efficacy of Medications COVID-19

San Carlos Clinical Hospital

Status: Completed

Conditions: Severe Covid-19

Treatments: Drug: Oral bedtime melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05596617

Meds Off-label

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive RT-PCR for SARS-CoV-2

Exclusion criteria

• Anticipated death within 48 hours or paliative care

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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335 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Standard of care management of severe Covid-19 patients

Oral bedtime melatonin

Experimental group

Description:

Standard of care with oral bedtime melatonin

Treatment:

Drug: Oral bedtime melatonin