Implementation of Good Clinical Practice in Early COVID-19 Pandemic

ABSTRACT

Introduction: The novel Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) has spread across the globe generating a pandemic. Every affected country has tried its best to mitigate the virus's effects. Aim: This study was designed to implement the good clinical practice in the Institute of Cardiovascular Diseases Timisoara (ICDT) for Coronavirus Disease-2019 (COVID-19) infection by a retrospective search for patients with a possible COVID-19 infection before widespread testing was available in our country. Materials and Methods: The retrospective study was conducted on selected group of 19 patients admitted to the ICDT, who displayed radiological signs of possible SARS-CoV-2 infection, between September 2019 and May 2020 in collaboration with the Radiology Department. Patients have been followed-up regarding their clinical status and asked to participate in Immunoglobulin G (IgG) antibody testing at a local laboratory. The patients were divided based on the period they were admitted to the hospital into four groups September-December 2019, January-February 2020, March-April 2020 and May 2020. The patients tested for coronavirus came from all four timeframes. Results: Only 13 patients (male female ratio was 103 ;mean age was 71.69 years) from the initial group were available and willing to answer a short interview and only five agreed to be tested for SARS-CoV-2 IgG antibodies. Most of the patients admitted to the hospital were suffering from acute myocardial infarction (30.7%), as well as heart failure (30.7%), followed by coronary heart disease (15.38%). A 30.7% of the patients had atrial fibrillation, 23% were also diagnosed with pneumonia during their hospital admission, 23% were also being treated for arterial hypertension, 7.69% had diabetes mellitus and Chronic Obstructive Pulmonary Diseases (COPD). Out of the five patients tested for IgG antibodies, two tested positive, with a titre above 1.4. Conclusion: The patients who have gone through the SARS-CoV-2 infection without being previously diagnosed were identified and followed-up on their health status. By conceiving and performing this study, the authors have strived to establish a new set of rules to advance and improve good clinical practice in unprecedented times.