Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

NCT04876573 | Unknown Phase 2

• 1 other identifier: 2022-2669
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical evolution according the WHO Clinical Progression Scale

  World Health Organisation Clinical Progression Scale for COVID 19 Minimal value 0 (uninfected) to maximal value 10 (Dead)

  Approximately 28 days

Secondary Outcomes (13)

• Incidence of Treatment-Emergent Adverse Events

  Approximately 28 days

• Recruitement rate

  6 month

• Completion rate

  6 month

• Rate of Death from any cause

  Approximately 28 days

• Total number of days of hospitalisation

  Approximately 28 days

Study Arms (1)

Cyproheptadine

EXPERIMENTAL

Drug: Cyproheptadine Hydrochloride 4 MG

Interventions

Cyproheptadine Hydrochloride 4 MG DRUG

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.

Cyproheptadine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

MeSH Terms

Conditions

Pneumonia, Viral; Serotonin Syndrome

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-04