Status:
UNKNOWN
Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19
Lead Sponsor:
Ciusss de L'Est de l'Île de Montréal
Conditions:
Viral Pneumonia
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 po...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04876573
Start Date
June 1 2021
End Date
January 31 2022
Last Update
May 6 2021
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