Severe Covid-19NCT05596617
Safety and Efficacy of Medications COVID-19
A study testing Oral bedtime melatonin in people with Severe Covid-19, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Covid-19
- What is being tested?
- Oral bedtime melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive RT-PCR for SARS-CoV-2
Who cannot join
- Anticipated death within 48 hours or paliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Drugs Given Off-label for COVID-19
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.
Read the 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
- Being tested
- Oral bedtime melatonin
- Keywords
- Covid-19, Adverse events, Organ dysfunction, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral bedtime melatoninDrug
Also called Standard of care
Different doses of oral bedtime melatonin
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of care management of severe Covid-19 patients |
| Oral bedtime melatonin | Experimental | Standard of care with oral bedtime melatonin Receives: Drug: Oral bedtime melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe adverse events
predefined severe adverse events
Measured: From date of inclusion until date of hospital discharge or death
Organ dysfunction
Sequential organ failure assessment score
Measured: 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
Measured: On days 30 and 90 since first dose of melatonin
Secondary outcomes (1)
Length of stay
Length of ICU and hospital stay
Measured: Date of inclusion until date of ICU and hospital discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start22 Apr 2020
- Primary completion31 May 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- quasi-experimental
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
- Investigators
- Jesus Fernandez-Tresguerres, MD.PhD, Study chair, Universidad Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596617
- Sponsor's protocol ID
- Meds Off-label
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, although after publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Drugs Given Off-label for COVID-19
- ClinicalTrials.gov ID
- NCT05596617
- Acronym / sponsor ID
- Meds Off-label
- Conditions
- Severe Covid-19
- Keywords
- Covid-19, Adverse events, Organ dysfunction, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of care management of severe Covid-19 patients |
| Oral bedtime melatonin | Experimental | Drug: Oral bedtime melatoninStandard of care with oral bedtime melatonin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Positive RT-PCR for SARS-CoV-2
Key exclusion criteria (1 listed)
- Anticipated death within 48 hours or paliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral bedtime melatoninAlso: Standard of careDifferent doses of oral bedtime melatonin | Drug | Oral bedtime melatonin |
Primary outcome
Severe adverse events
Time frame: From date of inclusion until date of hospital discharge or death
predefined severe adverse events
Organ dysfunction
Time frame: On days 1, 4, 7, 14 and 30 since first dose of melatonin
Sequential organ failure assessment score
Mortality
Time frame: On days 30 and 90 since first dose of melatonin
From date of inclusión to date of day 30 and day 90 mortality
1 secondary outcome
Length of stay
Time frame: Date of inclusion until date of ICU and hospital discharge or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Yes. Yes, although after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Fernandez-Tresguerres, MD.PhD study chair
Universidad Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral bedtime melatonin in people with Severe Covid-19, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse events (time frame: From date of inclusion until date of hospital discharge or death). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.