Status:

UNKNOWN

Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial

Lead Sponsor:

Ciusss de L'Est de l'Île de Montréal

Collaborating Sponsors:

Covid-19 Early Treatment Fund

Conditions:

Viral Pneumonia

Serotonin Syndrome

Eligibility:

All Genders

18-99 years

Phase:

PHASE3

Brief Summary

This randomized controled open label clinical trial is to evaluate the effect of Cyproheptadine on the clinical course of patients presenting a severe SARS-COV 2 pneumonia.

Detailed Description

Observational and biochemical studies have identified an interesting pathway in the pathophysiology of certain clinical-biological characteristics of COVID-19, linked to an excess of serotonin. We hyp...

Eligibility Criteria

Inclusion

  • Men and women age 18 or older
  • Hospitalized and requiring medical care for COVID-19
  • Presenting respiratory failure cause by COVID 19 requiring oxygen and/or mechanical ventilation support
  • With radiographic evidence of pulmonary infiltrate
  • Able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient

Exclusion

  • Pregnancy
  • Patients with pre-existing terminal condition with life expectancy \< 6 months
  • Patients with pre-existing severe lung disease requiring home O2
  • History of seizure disorder
  • History of adverse reaction to antihistamines or to Cyproheptadine

Key Trial Info

Start Date :

April 10 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04820751

Start Date

April 10 2021

End Date

January 1 2022

Last Update

April 2 2021

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