Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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

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COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyproheptadine and usual care

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.

Group Type EXPERIMENTAL

Cyproheptadine

Intervention Type DRUG

Cyproheptadine 8mg three times a day during 10 days

Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cyproheptadine

Cyproheptadine 8mg three times a day during 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No