Abstract

Efficacy and Safety of Pidotimod in SARS-CoV-2 Management: A Real-world Evidence Study

Author(s): Pradyut Waghray, Gouthami Jajapuram*, Purva Thatai and Vamsi Krishna Kolukula

Background: The role of pidotimod in immune stimulation in conditions like asthma, chronic obstructive pulmonary disease, and recurrent respiratory tract infections is well established. This has led to its exploration in COVID-19, which is also characterized by immune dysregulation. We determined the efficacy and safety of pidotimod in paucisymptomatic SARS-CoV-2 patients.

Methods: In this retrospective study, the electronic medical records (EMRs) of paucisymptomatic SARS-CoV-2 patients visiting the outpatient department at Kunal Institute of Medical Specialities Pvt Ltd, Bashir Bagh, Hyderabad, India between March 2021 and July 2021 were reviewed.  Patients having mild/moderate symptoms with PCR-documented SARS-CoV-2 positive from a nasopharyngeal sample were included in the study and divided into two groups (3:2): Group A (n=77) included patients who received pidotimod along with the standard of care treatment, and Group B (n=50) received only standard of care treatment for 14 days.  The effectiveness outcomes were the number of days taken for fever resolution, for relief of other symptoms, and negative swab test. Change in levels of various biomarkers involved in the pathogenesis of COVID-19 from baseline to 7days and 14days of treatment, was observed. Safety was assessed by adverse events reported during the treatment period.

Results: Overall, 140 patients were included, of which 13 were excluded as they had signs of pneumonia or respiratory failure. The mean age of the patients was 32.88 ± 10.86 and 31.20 ± 11.81 years in Group A and Group B respectively. Co-morbidities such as diabetes (28.6% in Group A and 24% in Group B) and hypertension (32.5% in Group A and 28% in Group B) were observed in the patients. The majority of the patients presented with fever and cough. Patients in Group A showed an earlier fever resolution (3.58 ± 1.04 days vs 7.29 ± 3.12 days) as well as earlier resolution of other symptoms (4.16  days ± 1.03 days vs. 7.10 days ± 2.45 days), when compared to Group B, respectively. Similarly, the swab test of patients was reported negative earlier (10.56 days ± 3.11 days) in Group A vs. Group B (13.74 days ± 2.45 days). Furthermore, a significant decline (p<0.001) in elevated levels of various biomarkers like CRP (64.27% vs. 59.52%) and IL-6 (51.03% vs. 33.31%) was observed after 14 days in patients receiving pidotimod, when compared with control group. A noteworthy improvement in the levels of d-dimer (521.48 ng/ml ± 166.14 ng/ml to 377.74 ng/ml ± 102.59 ng/ml) was observed in the pidotimod group after 7 days of treatment than that in the control group (656.58  ng/ml ± 193.93 ng/ml to 529.74 ng/ml ± 156.47 ng/ml); with corresponding reductions of 27.56% and 19.31%, respectively. Similarly, a significant reduction (p<0.001) in the levels of ferritin was found in the pidotimod group (45.66%) as compared to the control group (30.39%). No serious adverse events were reported during the 14 days of treatment in both groups.

Conclusion: Pidotimod, as an adjuvant therapy for the treatment of paucisymptomatic SARS-CoV-2 patients, was observed to decrease the levels of inflammatory mediators and other biological markers in patients. Pidotimod appears to have a potential role in managing SARS-CoV-2 patients.