COVID-19 Pneumonia Clinical Trial
Official title:
Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.
Verified date | April 2021 |
Source | Ciusss de L'Est de l'Île de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
Approximately 28 days | |
Secondary | Recruitement rate | 6 month | ||
Secondary | Completion rate | 6 month | ||
Secondary | Rate of Death from any cause | Approximately 28 days | ||
Secondary | Total number of days of hospitalisation | Approximately 28 days | ||
Secondary | Total number of days of hospitalization in the ICU | Approximately 28 days | ||
Secondary | Total number of days of mechanical ventilation | Approximately 28 days | ||
Secondary | Daily ROX ratio | Worst value of ROX ratio (SPO2/FiO2/Respiratory Rate) at D3,5,7,10,14,28 | Approximately 28 days | |
Secondary | Creatinine level | Worst value of Laboratory assessment of Creatinine at Days 3,5,7,10,14,28 after inclusion in the study | Approximately 28 days | |
Secondary | 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 | Approximately 28 days | |
Secondary | C Reactive Protein level | Worst value of Laboratory assessment of CRP at Days 3,5,7,10,14,28 after inclusion in the study | Approximately 28 days | |
Secondary | D-Dimere level | Worst value of Laboratory assessment of D-Dimere at Days 3,5,7,10,14,28 after inclusion in the study | Approximately 28 days | |
Secondary | Platelet count | Worst value of Laboratory assessment of platelet count at Days 3,5,7,10,14,28 after inclusion in the study | Approximately 28 days |
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