Safety and Efficacy of Medications COVID-19

NCT ID: NCT05596617

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-22
• Study Completion Date: 2022-03-31

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.

Conditions

Severe Covid-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of care management of severe Covid-19 patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oral bedtime melatonin

Standard of care with oral bedtime melatonin

Group Type: EXPERIMENTAL

Oral bedtime melatonin

Intervention Type: DRUG

Different doses of oral bedtime melatonin

Interventions

Oral bedtime melatonin

Different doses of oral bedtime melatonin

Intervention Type: DRUG

Other Intervention Names

Standard of care

Eligibility Criteria

Inclusion Criteria

• Positive RT-PCR for SARS-CoV-2

Exclusion Criteria

• Anticipated death within 48 hours or paliative care

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Miguel Sanchez Garcia

Director Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesus Fernandez-Tresguerres, MD.PhD

Role: STUDY_CHAIR

Universidad Complutense Madrid

Locations

Hospital Clinico San Carlos

Madrid, , Spain

Countries

Spain

Other Identifiers

Meds Off-label

Identifier Type: -

Identifier Source: org_study_id