Viral PneumoniaPhase 2NCT04876573
Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19
A Phase 2 study testing Cyproheptadine Hydrochloride 4 MG in people with Viral Pneumonia and COVID-19 Pneumonia, run by Ciusss de L'Est de l'Île de Montréal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Pneumonia, COVID-19 Pneumonia, Serotonin Syndrome
- What is being tested?
- Cyproheptadine Hydrochloride 4 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.
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.
Read the 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.
- Being tested
- Cyproheptadine Hydrochloride 4 MG
- Medical subject headings
- Pneumonia, Viral, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproheptadine Hydrochloride 4 MGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cyproheptadine | Experimental | Not described Receives: Drug: Cyproheptadine Hydrochloride 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Approximately 28 days
Secondary outcomes (13)
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
Measured: Approximately 28 days
Recruitement rate
Measured: 6 month
Completion rate
Measured: 6 month
Rate of Death from any cause
Measured: Approximately 28 days
Total number of days of hospitalisation
Measured: Approximately 28 days
Total number of days of hospitalization in the ICU
Measured: Approximately 28 days
Total number of days of mechanical ventilation
Measured: Approximately 28 days
Daily ROX ratio
Worst value of ROX ratio (SPO2/FiO2/Respiratory Rate) at D3,5,7,10,14,28
Measured: Approximately 28 days
Creatinine level
Worst value of Laboratory assessment of Creatinine at Days 3,5,7,10,14,28 after inclusion in the study
Measured: Approximately 28 days
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
Measured: Approximately 28 days
C Reactive Protein level
Worst value of Laboratory assessment of CRP at Days 3,5,7,10,14,28 after inclusion in the study
Measured: Approximately 28 days
D-Dimere level
Worst value of Laboratory assessment of D-Dimere at Days 3,5,7,10,14,28 after inclusion in the study
Measured: Approximately 28 days
Platelet count
Worst value of Laboratory assessment of platelet count at Days 3,5,7,10,14,28 after inclusion in the study
Measured: Approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876573
- Sponsor's protocol ID
- 2022-2669
- Status last verified
- Apr 2021
- First submitted
- 3 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19: a Single-center, Observational Retrospective-prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT04876573
- Acronym / sponsor ID
- 2022-2669
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyproheptadine | Experimental | Drug: Cyproheptadine Hydrochloride 4 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyproheptadine Hydrochloride 4 MGPhase 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. | Drug | Cyproheptadine |
Primary outcome
Clinical evolution according the WHO Clinical Progression Scale
Time frame: Approximately 28 days
World Health Organisation Clinical Progression Scale for COVID 19 Minimal value 0 (uninfected) to maximal value 10 (Dead)
13 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 28 days
Recruitement rate
Time frame: 6 month
Completion rate
Time frame: 6 month
Rate of Death from any cause
Time frame: Approximately 28 days
Total number of days of hospitalisation
Time frame: Approximately 28 days
Total number of days of hospitalization in the ICU
Time frame: Approximately 28 days
Total number of days of mechanical ventilation
Time frame: Approximately 28 days
Daily ROX ratio
Time frame: Approximately 28 days
Creatinine level
Time frame: Approximately 28 days
Alanine amino transferase level
Time frame: Approximately 28 days
C Reactive Protein level
Time frame: Approximately 28 days
D-Dimere level
Time frame: Approximately 28 days
Platelet count
Time frame: Approximately 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
Related trials for Viral Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyproheptadine Hydrochloride 4 MG in people with Viral Pneumonia and COVID-19 Pneumonia, run by Ciusss de L'Est de l'Île de Montréal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evolution according the WHO Clinical Progression Scale (time frame: Approximately 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.