Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborator: Covid-19 Early Treatment Fund
• Treatments: Cyproheptadine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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