Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Pilot study for evaluating the feasibility, security and efficacy of the use of Cypropheptadine, an antihistaminic and antiserotonin drug, as an adjunct of the standardized treatment in a population of patient who are hospitalized and requiring oxygen therapy for COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Treatments: Cyproheptadine

Criteria

Inclusion Criteria:

• Women and men aged 18 and over.

• Requiring treatment for COVID 19 and whose clinical status corresponds to a score equal to or greater than 5 on the WHO Clinical Progression Scale.

• For the prospective study, able to give informed consent.

• Not presenting an exclusion criterion

Exclusion Criteria:

• Pregnancy

• Patients with pre-existing terminal condition with life expectancy < 6 months

• Patient with clinically frailty according to a score of the clinical frailty scale equal or superior to 7

• Patients with pre-existing severe lung disease requiring home oxygen therapy.

• Patients with pre-existing severe hepatic cirrhosis (Grade C according to the Child-Pugh classification)

• Patients with pre-existing kidney failure (GFR strictly less than 15ml/min/1.73m2 according The KDIGO classification) or requiring renal replacement therapy.

• Patients with pre-existing angle-closure glaucoma

• Patient with symptomatic prostatic hypertrophy or bladder neck obstruction

• Patient with history of seizure disorder

• Patient with history of adverse reaction to antihistamines or to Cyproheptadine

• Patients taking routinely SSRI or monoamine oxidase inhibitor therapy.

• Patients presenting severe hepatic cytolysis with ALP >5 ULN at the time of study inclusion.