Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19

July 27, 2021 updated by: Márcio Manozzo Boniatti, Hospital de Clinicas de Porto Alegre
This randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the ICU and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the number of ventilator-free days.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Some studies have shown increased platelet activation and reactivity in patients with COVID-19. This platelet activation is associated with serotonin release. Some characteristics observed during the evolution of COVID-19 may be associated with these increased levels of serotonin. In this scenario, the antagonism of the action of serotonin could improve the clinical course of patients affected by COVID-19. Cyprohepatdine is an anti-serotonergic antihistamine drug with a long track record of safety and tolerability.

Investigators will randomize 274 patients who have tested positive for COVID-19 and who will be admitted to the ICU requiring ventilatory support (invasive or non-invasive).

Patients will be randomized to a 1:1 ratio for receiving usual care + cyproheptadine (8mg three times a day for 10 days) or usual care.

Patients will be followed until discharge to determine length of stay in the ICU and hospital, mortality in the ICU and hospital and days free from ventilatory support during the first 28 days.

Study Type

Interventional

Enrollment (Anticipated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
        • Recruiting
        • Hospital de Clínica de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive PCR for SARS-Cov-2
  • ICU admission < 48 hours
  • Age 18 years or older
  • Need for invasive or non-invasive ventilatory support (non-invasive ventilation or high-flow nasal cannula) < 48 hours

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Refusal to sign the informed consent form
  • Expected death in the next 24 hours
  • Patients taking routinely SSRI or monoamine oxidase inhibitor therapy
  • Impossibility of using the enteral route
  • History of seizure disorder
  • History of adverse reaction to antihistamines or to cyproheptadine
  • Readmission to the ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyproheptadine and usual care

Patients allocated to the intervention group will receive cyproheptadine within 6 hours after randomization, at a dose of 8mg every 8 hours for 10 days.

Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution.
Drug: Cyproheptadine
Cyproheptadine 8mg three times a day during 10 days
No Intervention: Usual care
Usual care (diagnostic testing, antibiotic administration, fluid resuscitation, hemodynamic management, and ventilatory support) will be applied in accordance with the clinical practice of each institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory support
Time Frame: Day 28
Number of days free from ventiltory support during the first 28 days
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation
Time Frame: Through study completion, an average of 6 months
Duration of mechanical ventilation
Through study completion, an average of 6 months
Mortality during 28 days
Time Frame: Day 28
Day 28
ICU Mortality
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Hospital Mortality
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Length of stay in the intensive care unit
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Length of stay in the hospital
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months
Renal replacement therapy
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: MARCIO M BONIATTI, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Anticipated)

January 26, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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