ABSTRACT
Background: Antivirals and immunosuppressive agents are used with variable success in the treatment of COVID-19. Mycophenolate, an inhibitor of enzyme inosine monophosphate dehydrogenase, is an immunosuppressant used to prevent allograft rejection and other autoimmune diseases. Few laboratory studies have also reported antiviral properties of mycophenolate. The current study tried to assess the safety and efficacy of mycophenolate in patients hospitalised with COVID-19. Methods: This was a prospective non-randomised open label study with the objective to assess the effect of addition of mycophenolate to the standard of care on mortality due to COVID-19 and duration of hospital stay. The target study population was comprised of patients requiring inpatient treatment for COVID-19 during the period from Jan 15-April 15, 2021. The study was registered with Clinical Trial Registry of India (CTRI/2021/01/030477, registered on date-14/01/2021). Adult patients (n = 106) requiring hospitalisation for COVID-19 received mycophenolate, 360 mg, one tablet daily for one month. Mycophenolate was initiated within 48 h of the diagnosis of SARS-CoV-2 infection by RTâPCR. While patients who did not consent for mycophenolate (n = 106), received only standard of care, and were considered as control group. The relevant clinical data including NEWS2 scores and high-resolution computed tomography of the thorax were collected and analysed. Findings: The mortality and hospital stay were significantly lower in the study group compared to the control group. Mycophenolate significantly reduced mortality after adjustment for other predictors (adjusted odds ratio: 0.082 with 95% CI: 0.012-0.567). Mycophenolate was an independent predictor of survival in patients hospitalised due to COVID-19. There was also no evidence of secondary bacterial infections and post-COVID complications. Interpretation: Mycophenolate administration is safe in COVID-19. Mycophenolate reduces mortality and duration of hospital stay in patients with COVID-19. Funding: Shri Janai Research Foundation, India.
ABSTRACT
The QT interval, apart from clinical implications is crucial for safety assessment of new drugs under development. A QTc prolongation of even 10 msec in a study group is a warning signal for a new drug. There are various issues involved in the measurement of the QT interval especially regarding the ending of the T wave and different morphological pattern of T-U complex. The other issue is significant spontaneous variability in the QT interval, resulting in spurious QT prolongation and unnecessary concern.To minimize all these confounding factors, all clinical trials for assessing QT interval prolongation should be randomized and double blinded with appropriate control groups including placebo. ECG measurements should be done by trained readers with electronic calipers at ECG core Lab. ECGs should be compared with multiple baseline values with multiple, time-matched on-treatment values.
