Back to resultsSafety and Efficacy of Medications COVID-19
Primary Purpose
Severe Covid-19
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oral bedtime melatonin
Sponsored by
About this trial
This is an interventional treatment trial for Severe Covid-19 focused on measuring Covid-19, Adverse events, Organ dysfunction, Mortality
Eligibility Criteria
Inclusion Criteria:
- Positive RT-PCR for SARS-CoV-2
Exclusion Criteria:
- Anticipated death within 48 hours or paliative care
Sites / Locations
- Hospital Clinico San Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Oral bedtime melatonin
Arm Description
Standard of care management of severe Covid-19 patients
Standard of care with oral bedtime melatonin
Outcomes
Primary Outcome Measures
Severe adverse events
predefined severe adverse events
Organ dysfunction
Sequential organ failure assessment score
Mortality
From date of inclusión to date of day 30 and day 90 mortality
Secondary Outcome Measures
Length of stay
Length of ICU and hospital stay
Full Information
NCT ID
NCT05596617
First Posted
October 20, 2022
Last Updated
October 26, 2022
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05596617
Brief Title
Safety and Efficacy of Medications COVID-19
Official Title
Safety and Efficacy of Drugs Given Off-label for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Covid-19
Keywords
Covid-19, Adverse events, Organ dysfunction, Mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
quasi-experimental
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care management of severe Covid-19 patients
Arm Title
Oral bedtime melatonin
Arm Type
Experimental
Arm Description
Standard of care with oral bedtime melatonin
Intervention Type
Drug
Intervention Name(s)
Oral bedtime melatonin
Other Intervention Name(s)
Standard of care
Intervention Description
Different doses of oral bedtime melatonin
Primary Outcome Measure Information:
Title
Severe adverse events
Description
predefined severe adverse events
Time Frame
From date of inclusion until date of hospital discharge or death
Title
Organ dysfunction
Description
Sequential organ failure assessment score
Time Frame
On days 1, 4, 7, 14 and 30 since first dose of melatonin
Title
Mortality
Description
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
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of ICU and hospital stay
Time Frame
Date of inclusion until date of ICU and hospital discharge or death
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive RT-PCR for SARS-CoV-2
Exclusion Criteria:
Anticipated death within 48 hours or paliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Fernandez-Tresguerres, MD.PhD
Organizational Affiliation
Universidad Complutense Madrid
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes, although after publication
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Privision of an analysis plan
Learn more about this trial
Safety and Efficacy of Medications COVID-19
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