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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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 number of ventilator-free days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Cyproheptadine

Criteria

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