Trial design and patients
Hyperkalaemia, hypersensitivity
COVID-19 PNEUMONIA, ELECTROLYTE DISTURBANCE, HYPERSENSITIVITY, DELHI
The trial was a single centre RCT. Patients were recruited between 01 February to 30 April 2021 from Maulana Azad Medical College and Lok Nayak Hospital, New Delhi. Patients were recruited if they had positive nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) and/or had chest radiographic changes consistent with COVID-19 pneumonia, with an additional oxygen requirement (oxygen saturations (SpO2) < 94% on room air but maintaining SpO2 of ≥ 94% on supplemental oxygen by mask or nasal prongs). Exclusion criteria were: participation in another clinical trial of an investigational medicinal product (IMP); mechanical ventilation; known hypersensitivity to the IMP; significant electrolyte disturbance (Hyperkalaemia: KA sample size calculation was based on a primary biomarker endpoint (D-dimer: selected for its association with poor Covid-19 outcomes [