Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Randomized, Placebo Controlled, Double Blinded, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of AEV01 for Mild COVID19 in Elderly Patients at Risk of Complications

Version 1 : Received: 5 May 2022 / Approved: 7 May 2022 / Online: 7 May 2022 (05:47:32 CEST)

How to cite: KANNAN, R.; MURALIKUMAR, V.; ANNAM, V.; BALAN, S.; KUMAR, A.; MM, S.; MEDASANI, R. A Randomized, Placebo Controlled, Double Blinded, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of AEV01 for Mild COVID19 in Elderly Patients at Risk of Complications. Preprints 2022, 2022050094 (doi: 10.20944/preprints202205.0094.v1). KANNAN, R.; MURALIKUMAR, V.; ANNAM, V.; BALAN, S.; KUMAR, A.; MM, S.; MEDASANI, R. A Randomized, Placebo Controlled, Double Blinded, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of AEV01 for Mild COVID19 in Elderly Patients at Risk of Complications. Preprints 2022, 2022050094 (doi: 10.20944/preprints202205.0094.v1).

Abstract

Background: While several drugs are in the pipeline for treatment of various grades of COVID-19 disease, none of them have shown promise until now. Medicinal plants are crucial in developing and developed countries for their primary and basic health needs owing to better tolerability, superior compatibility with human body and having lesser side effects. AEV01 , a speciality extract of kutki (Picrorhiza kurroa), is one potential medicinal herb which can be effective for mild COVID19 in elderly patients at risk of complications and aging immunity. Purpose: The efficacy and safety of AEV01 for mild COVID-19 in elderly patients at risk of complications was investigated in this study. Study design: A prospective, phase 3, randomized, multicentric, placebo controlled double blinded parallel group interventional trial. Methods: This study was conducted in elderly patients diagnosed as COVID-19 with mild symptoms. 70 patients were randomized into two groups to receive AEV01 capsule (100mg) and placebo respectively thrice daily for 30 days along with standard care of treatment as per national WHO/ICMR guidelines. Clinical improvement timelines and corresponding scores using 8-point ordinal scale and NEWS were assessed for efficacy and safety of AEV01 in COVID-19 patients. Results: AEV01 group showed a significant improvement (P=0.0001) in the normalization of the SpO2 rate and relief from cough. There was also significant difference in time to recovery, with patients in the AEV01 drugtreated group recovering in 4.5 days as compared to Placebo in 9.1 days. ESR, LDH, serum ferritin, Neutrophil-Lymphocyte ratio (NLR), TNF- alpha, IL-6 and CD4 cell counts, which are considered as prognostic markers in COVID19 infected patients, showed a significant improvement in patients treated with AEV01. The AEV01 drug treated group showed significant clinical improvement in the 8-point ordinal scale severity rating and NEW Score from day 3 onwards which continued up to end of study. Conclusion: AEV01 has shown a significant improvement in clinical and laboratory parameters. There was also reduction in the progression of the COVID-19 disease in unvaccinated elderly patients from mild to moderate when treated at an earlier stage.

Keywords

COVID-19; Picrorhiza kurroa; AEV01; NEW Score; Immunomodulatory; unvaccinated elderly population

Subject

MEDICINE & PHARMACOLOGY, Pharmacology & Toxicology

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