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Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

Primary Purpose

Viral Pneumonia, COVID-19 Pneumonia, Serotonin Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cyproheptadine Hydrochloride 4 MG
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cyproheptadine

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events
    Safety evaluation, as measured by suspected as related to cyproheptadine during the first 28 days after inclusion in the study: Adverse events Adverse drug reactions Serious adverse event and adverse drug reaction
    Recruitement rate
    Completion rate
    Rate of Death from any cause
    Total number of days of hospitalisation
    Total number of days of hospitalization in the ICU
    Total number of days of mechanical ventilation
    Daily ROX ratio
    Worst value of ROX ratio (SPO2/FiO2/Respiratory Rate) at D3,5,7,10,14,28
    Creatinine level
    Worst value of Laboratory assessment of Creatinine at Days 3,5,7,10,14,28 after inclusion in the study
    Alanine amino transferase level
    Worst value of Laboratory assessment of Alanine amino transferase at Days 3,5,7,10,14,28 after inclusion in the study
    C Reactive Protein level
    Worst value of Laboratory assessment of CRP at Days 3,5,7,10,14,28 after inclusion in the study
    D-Dimere level
    Worst value of Laboratory assessment of D-Dimere at Days 3,5,7,10,14,28 after inclusion in the study
    Platelet count
    Worst value of Laboratory assessment of platelet count at Days 3,5,7,10,14,28 after inclusion in the study

    Full Information

    First Posted
    May 3, 2021
    Last Updated
    May 5, 2021
    Sponsor
    Ciusss de L'Est de l'Île de Montréal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04876573
    Brief Title
    Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19
    Official Title
    Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ciusss de L'Est de l'Île de Montréal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Viral Pneumonia, COVID-19 Pneumonia, Serotonin Syndrome, Platelet Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cyproheptadine
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Cyproheptadine Hydrochloride 4 MG
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Clinical evolution according the WHO Clinical Progression Scale
    Description
    World Health Organisation Clinical Progression Scale for COVID 19 Minimal value 0 (uninfected) to maximal value 10 (Dead)
    Time Frame
    Approximately 28 days
    Secondary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Safety evaluation, as measured by suspected as related to cyproheptadine during the first 28 days after inclusion in the study: Adverse events Adverse drug reactions Serious adverse event and adverse drug reaction
    Time Frame
    Approximately 28 days
    Title
    Recruitement rate
    Time Frame
    6 month
    Title
    Completion rate
    Time Frame
    6 month
    Title
    Rate of Death from any cause
    Time Frame
    Approximately 28 days
    Title
    Total number of days of hospitalisation
    Time Frame
    Approximately 28 days
    Title
    Total number of days of hospitalization in the ICU
    Time Frame
    Approximately 28 days
    Title
    Total number of days of mechanical ventilation
    Time Frame
    Approximately 28 days
    Title
    Daily ROX ratio
    Description
    Worst value of ROX ratio (SPO2/FiO2/Respiratory Rate) at D3,5,7,10,14,28
    Time Frame
    Approximately 28 days
    Title
    Creatinine level
    Description
    Worst value of Laboratory assessment of Creatinine at Days 3,5,7,10,14,28 after inclusion in the study
    Time Frame
    Approximately 28 days
    Title
    Alanine amino transferase level
    Description
    Worst value of Laboratory assessment of Alanine amino transferase at Days 3,5,7,10,14,28 after inclusion in the study
    Time Frame
    Approximately 28 days
    Title
    C Reactive Protein level
    Description
    Worst value of Laboratory assessment of CRP at Days 3,5,7,10,14,28 after inclusion in the study
    Time Frame
    Approximately 28 days
    Title
    D-Dimere level
    Description
    Worst value of Laboratory assessment of D-Dimere at Days 3,5,7,10,14,28 after inclusion in the study
    Time Frame
    Approximately 28 days
    Title
    Platelet count
    Description
    Worst value of Laboratory assessment of platelet count at Days 3,5,7,10,14,28 after inclusion in the study
    Time Frame
    Approximately 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

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