NCT04876573

Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ciusss de L'Est de l'Île de Montréal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background : Biochemical studies have revealed a significant increase in plasma serotonin levels in patients suffering from COVID-19 multi-organ disease, which appears to be a consequence of platelet hyperreactivity and dysfunction. Among the several potential therapeutic pathways available to modulate this serotonin dysregulation is the use of cyproheptadine, an Anti-serotonergic antihistamine that can potentially improve organ dysfunction related to elevated plasma serotonin levels. The investigators hypothesize that treatment with cyproheptadine will improve clinical course in these patients. Objectives: Primary objective Compare the clinical course according to the WHO ordinal severity score for COVID-19, between a retrospective and a prospective interventional cohort of patient hospitalized in the same hospital. Secondary objectives Evaluate the safety of the use of the cyproheptadine hospitalized patients presenting COVID 19. Evaluate the study in term of Feasibility Recruitment rate and Study completion rate. Evaluate the outcome in term of Death, Needs of Non-invasive and/or invasive mechanical ventilation and Total Length of hospitalization Evaluate the evolution of clinical indicators of oxygenation and blood parameters of inflammation, renal function, hepatic cytolysis and platelet count. Design: This pilot trial is a non-blinded clinical designed to access the feasibility, the security and the efficacy of the use of Cyproheptadine in patient hospitalized in a single center for Covid-19 with comparison between: A retrospective cohort study of patient and treated by standard care according to WHO international guidelines. A prospective study of a cohort of patients hospitalized for covid 19 taking oral Cyproheptadine during 10 days in addition to standard care according to WHO international guidelines. The prospective study will be divided into two different phases in which two different doses of cyproheptadine will be administered.

Conditions

• Viral Pneumonia
• COVID-19 Pneumonia
• Serotonin Syndrome
• Platelet Dysfunction

Interventions

Type	Name	Description
DRUG	Cyproheptadine Hydrochloride 4 MG	Phase 1: Cyproheptadine 4 mg three time a day for 10 days, per oral administration associated to Standard care of COVID 19 patient currently recommend by WHO Phase 2: Cyproheptadine 8 mg three time a day for 10 days, per oral administration associated to Standard care of COVID 19 patient currently recommend by WHO The dose will be adjusted according to the renal function.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-05-06
• Last updated: 2021-05-06