COVID-19 Pneumonia
Conditions
Brief 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.
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.
Interventions
DRUGCyproheptadine
Cyproheptadine 8mg three times a day during 10 days
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory support | Day 28 | Number of days free from ventiltory support during the first 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in the intensive care unit | Through study completion, an average of 6 months | — |
| Length of stay in the hospital | Through study completion, an average of 6 months | — |
| Mechanical ventilation | Through study completion, an average of 6 months | Duration of mechanical ventilation |
| Renal replacement therapy | Day 28 | — |
| ICU Mortality | Through study completion, an average of 6 months | — |
| Hospital Mortality | Through study completion, an average of 6 months | — |
| Mortality during 28 days | Day 28 | — |
Countries
Brazil
Contacts
Primary ContactMarcio M Boniatti, PhD
Outcome results
None listed