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

NCT04979221 | Unknown Phase 3 DMC

• 1 other identifier: 2021-0157
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Ventilatory support

  Number of days free from ventiltory support during the first 28 days

  Day 28

Secondary Outcomes (7)

• Mechanical ventilation

  Through study completion, an average of 6 months

• Mortality during 28 days

  Day 28

• ICU Mortality

  Through study completion, an average of 6 months

• Hospital Mortality

  Through study completion, an average of 6 months

• Length of stay in the intensive care unit

  Through study completion, an average of 6 months

Study Arms (2)

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.

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.

Interventions

Cyproheptadine DRUG

Cyproheptadine 8mg three times a day during 10 days

Cyproheptadine and usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínica de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Interventions

Cyproheptadine

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Marcio M Boniatti, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcio M Boniatti, PhD

CONTACT

55 51 3359 8000; mboniatti@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 28, 2021
• Study Start: July 26, 2021
• Primary Completion: January 26, 2022
• Study Completion: February 28, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

BR (1)