Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
This randomized controled open label clinical trial is to evaluate the effect of Cyproheptadine on the clinical course of patients presenting a severe SARS-COV 2 pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2021
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
April 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedApril 2, 2021
March 1, 2021
7 months
March 25, 2021
March 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Length of hospitalization
Through study completion, an average of 1 year
Need mechanical ventilation (Non invasive or Invasive)
Through study completion, an average of 1 year
Secondary Outcomes (11)
Death
Day 28
Length of hospitalization in the intensive care unit
Through study completion, an average of 1 year
Duration of mechanical ventilation
Through study completion, an average of 1 year
SOFA Score
At Day 1,3,5,7,10 after randomization
Heart rate
At Day 1,3,5,7,10 after randomization
- +6 more secondary outcomes
Study Arms (2)
Cyproheptadine and standard care
EXPERIMENTALStart Cyproheptadine 8mg three times a day during 5 days. Dose will be reduced to 4mg three times a day if GFR inferior to 30ml/min/1.73m² Standard management of COVID-19 infection according to current international guidelines
Standard care
NO INTERVENTIONStandard management of COVID-19 infection according to current international guidelines
Interventions
Cyproheptadine associated to standard care
Eligibility Criteria
You may qualify if:
- Men and women age 18 or older
- Hospitalized and requiring medical care for COVID-19
- Presenting respiratory failure cause by COVID 19 requiring oxygen and/or mechanical ventilation support
- With radiographic evidence of pulmonary infiltrate
- Able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient
You may not qualify if:
- Pregnancy
- Patients with pre-existing terminal condition with life expectancy \< 6 months
- Patients with pre-existing severe lung disease requiring home O2
- History of seizure disorder
- History of adverse reaction to antihistamines or to Cyproheptadine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
April 10, 2021
Primary Completion
November 1, 2021
Study Completion
January 1, 2022
Last Updated
April 2, 2021
Record last verified: 2021-03