COVID-19 PneumoniaPhase 3NCT04979221
Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19
A Phase 3 study testing Cyproheptadine in people with COVID-19 Pneumonia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the ICU and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Cyproheptadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jul 2021to 28 Feb 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive PCR for SARS-Cov-2
- ICU admission < 48 hours
- Age 18 years or older
- Need for invasive or non-invasive ventilatory support (non-invasive ventilation or high-flow nasal cannula) < 48 hours
Who cannot join
- Pregnancy or breastfeeding
- Refusal to sign the informed consent form
- Expected death in the next 24 hours
- Patients taking routinely SSRI or monoamine oxidase inhibitor therapy
- Impossibility of using the enteral route
- History of seizure disorder
- History of adverse reaction to antihistamines or to cyproheptadine
- Readmission to the ICU
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínica de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Marcio M Boniatti, PhD, 55 51 33598000, mboniatti@hcpa.edu.br
About this study
This randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the ICU and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the number of ventilator-free days.
Read the detailed description
Some studies have shown increased platelet activation and reactivity in patients with COVID-19. This platelet activation is associated with serotonin release. Some characteristics observed during the evolution of COVID-19 may be associated with these increased levels of serotonin. In this scenario, the antagonism of the action of serotonin could improve the clinical course of patients affected by COVID-19. Cyprohepatdine is an anti-serotonergic antihistamine drug with a long track record of safety and tolerability.
Investigators will randomize 274 patients who have tested positive for COVID-19 and who will be admitted to the ICU requiring ventilatory support (invasive or non-invasive).
Patients will be randomized to a 1:1 ratio for receiving usual care + cyproheptadine (8mg three times a day for 10 days) or usual care.
Patients will be followed until discharge to determine length of stay in the ICU and hospital, mortality in the ICU and hospital and days free from ventilatory support during the first 28 days.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Cyproheptadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyproheptadineDrug
Cyproheptadine 8mg three times a day during 10 days
| Study group | Role | What they receive |
|---|---|---|
| Cyproheptadine and usual care | Experimental | Patients allocated to the intervention group will receive cyproheptadine within 6 hours after randomization, at a dose of 8mg every 8 hours for 10 days.
Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution. Receives: Drug: Cyproheptadine |
| Usual care | No intervention | Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory support
Number of days free from ventiltory support during the first 28 days
Measured: Day 28
Secondary outcomes (7)
Mechanical ventilation
Duration of mechanical ventilation
Measured: Through study completion, an average of 6 months
Mortality during 28 days
Measured: Day 28
ICU Mortality
Measured: Through study completion, an average of 6 months
Hospital Mortality
Measured: Through study completion, an average of 6 months
Length of stay in the intensive care unit
Measured: Through study completion, an average of 6 months
Length of stay in the hospital
Measured: Through study completion, an average of 6 months
Renal replacement therapy
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start26 Jul 2021
- Primary completion26 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márcio Manozzo Boniatti, Hospital de Clinicas de Porto Alegre
- Investigators
- Marcio M Boniatti, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979221
- Sponsor's protocol ID
- 2021-0157
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04979221
- Acronym / sponsor ID
- 2021-0157
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 26 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 28 Jul 2021 (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.
This randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the ICU and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the number of ventilator-free days.
Detailed description
Some studies have shown increased platelet activation and reactivity in patients with COVID-19. This platelet activation is associated with serotonin release. Some characteristics observed during the evolution of COVID-19 may be associated with these increased levels of serotonin. In this scenario, the antagonism of the action of serotonin could improve the clinical course of patients affected by COVID-19. Cyprohepatdine is an anti-serotonergic antihistamine drug with a long track record of safety and tolerability.
Investigators will randomize 274 patients who have tested positive for COVID-19 and who will be admitted to the ICU requiring ventilatory support (invasive or non-invasive).
Patients will be randomized to a 1:1 ratio for receiving usual care + cyproheptadine (8mg three times a day for 10 days) or usual care.
Patients will be followed until discharge to determine length of stay in the ICU and hospital, mortality in the ICU and hospital and days free from ventilatory support during the first 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyproheptadine and usual care | Experimental | Drug: CyproheptadinePatients allocated to the intervention group will receive cyproheptadine within 6 hours after randomization, at a dose of 8mg every 8 hours for 10 days. Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution. |
| Usual care | No intervention | –Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive PCR for SARS-Cov-2
- ICU admission < 48 hours
- Age 18 years or older
- Need for invasive or non-invasive ventilatory support (non-invasive ventilation or high-flow nasal cannula) < 48 hours
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Refusal to sign the informed consent form
- Expected death in the next 24 hours
- Patients taking routinely SSRI or monoamine oxidase inhibitor therapy
- Impossibility of using the enteral route
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 |
|---|---|---|
| CyproheptadineCyproheptadine 8mg three times a day during 10 days | Drug | Cyproheptadine and usual care |
Primary outcome
Ventilatory support
Time frame: Day 28
Number of days free from ventiltory support during the first 28 days
7 secondary outcomes
Mechanical ventilation
Time frame: Through study completion, an average of 6 months
Mortality during 28 days
Time frame: Day 28
ICU Mortality
Time frame: Through study completion, an average of 6 months
Hospital Mortality
Time frame: Through study completion, an average of 6 months
Length of stay in the intensive care unit
Time frame: Through study completion, an average of 6 months
Length of stay in the hospital
Time frame: Through study completion, an average of 6 months
Renal replacement therapy
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Marcio M Boniatti, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyproheptadine in people with COVID-19 Pneumonia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcio M Boniatti, PhD (55 51 3359 8000, mboniatti@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory support (time frame: Day 28). 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 3 Aug 2021.