Clinical trial NCT04978051: Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection
Official title: Randomized, Open, Multicenter Phase II Clinical Trial, Proof of Concept, to Evaluate Efficacy and Safety of Icatibant in Hospitalized Patients With SARS-COV-2 (COVID-19) Without Assisted Ventilation Compared With Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Pneumonia
Keywords: icatibant
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.


Eligibility criteria: Inclusion Criteria:

1. adult patients (18 years or older), both sexes
2. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
3. hospitalized with a diagnosis of SARS-CoV-2 pneumonia
4. radiographic evidence of pulmonary infiltrates
5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
6. pO2/FiO2 \<380
7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
8. obtaining the informed consent of the patient or the legal representative.

Exclusion Criteria:

1. imminent death (life expectancy less than 72h)
2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
3. invasive mechanical ventilation
4. participation in any other clinical trial
5. ALT or AST \> 5 x ULN
6. creatinine clearance \<50 mL/min using the Cockcroft-Gault formula for participants '18 years old \[Cockcroft 1976\]
7. patients with recent acute coronary syndrome (\<1 month)
8. patients with a history of stroke
9. positive pregnancy test
10. pregnant or lactating woman

Primary outcomes:
measure: Efficacy of experimental treatment
timeFrame: up to 10 days
measure: Safety of experimental treatment
timeFrame: up to 10 days
Secondary outcomes:
measure: Long-term efficacy
timeFrame: up to 10 days
measure: Time to achive a clinical response
timeFrame: up to 40 days
measure: Time to achive an afebrile state
timeFrame: up to 40 days
measure: time from symptom onset to treatment
timeFrame: up to day 1
measure: Responders
timeFrame: up to 40 days
measure: COVID-19 related relapse
timeFrame: up to 40 days
measure: Patients with Adverse Events
timeFrame: up to 40 days
measure: Adverse Events
timeFrame: up to 40 days
measure: Serious Adverse Events
timeFrame: up to 40 days
measure: Overall mortality
timeFrame: up to 40 days
measure: COVID-19 related mortality
timeFrame: up to 40 days
measure: Time until death
timeFrame: up to 40 days
measure: COVID-19-related complications
timeFrame: up to 40 days
measure: Patients requiring intensive care
timeFrame: up to 40 days
measure: patients requiring intensive care and invasive mechanical ventilation
timeFrame: up to 40 days
measure: patients requiring oxygen supplementation
timeFrame: up to 40 days
measure: Patients with nonsocomial infection
timeFrame: up to 40 days
measure: Rehospitalizations
timeFrame: up to 40 days
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Catalonia
Study officials:
References:
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