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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979221
• Other study ID #: 2021-0157
• Status: Recruiting
• Phase: Phase 3
• Start date: July 26, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Marcio M Boniatti, PhD
• Phone: 55 51 3359 8000
• Email: mboniatti[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: February 28, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Critical Illness
• Pneumonia

Intervention

Drug:
• Cyproheptadine
Cyproheptadine 8mg three times a day during 10 days

Locations

Country	Name	City	State
Brazil	Hospital de Clínica de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory support	Number of days free from ventiltory support during the first 28 days	Day 28
Secondary	Mechanical ventilation	Duration of mechanical ventilation	Through study completion, an average of 6 months
Secondary	Mortality during 28 days		Day 28
Secondary	ICU Mortality		Through study completion, an average of 6 months
Secondary	Hospital Mortality		Through study completion, an average of 6 months
Secondary	Length of stay in the intensive care unit		Through study completion, an average of 6 months
Secondary	Length of stay in the hospital		Through study completion, an average of 6 months
Secondary	Renal replacement therapy		Day 28