Status:
COMPLETED
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Lead Sponsor:
Nicolaus Copernicus University
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
Brief Summary
There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking io...
Eligibility Criteria
Inclusion
- Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) \> 200.
Exclusion
- Acute respiratory distress syndrome (ARDS)
- Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
- Long QT syndrome
- Prolonged baseline QTc interval (≥450 ms).
- Cardiogenic shock or severe hypotension (SBP\< 90 mmHg)
- Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
- Severe sinus - node dysfunction with marked sinus bradycardia
- 2nd/3rd degree heart block
- Bradycardia without pacemaker that has caused syncope
- History of severe dysthyroidism
- A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2021
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT04351763
Start Date
May 20 2020
End Date
June 5 2021
Last Update
September 5 2021
Active Locations (1)
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1
Nicolaus Copernicus University
Bydgoszcz, Poland