Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19 (NCT04876573) | Clinical Trial Compass
UnknownPhase 2
Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19
60 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical evolution according the WHO Clinical Progression Scale