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Proof roof of concept study to evaluate the safety and effectiveness of a novel Favipiravir dry powder inhalation formulation in subjects with SARS-COV-2 infection

Volume No : (2021) Volume: 09 Issue : 43 Year : 2021 Page No: 48-58

Authors : Vidyadhar Vaidya, Sonali Nirhali, Ramshyam Agarwal

Abstract :

Aim: The present study is the first hand evidence of the clinical use of dry powder for inhalation (DPI) dosage form of Favipiravir (Favi DPI) in mild to moderate COVID-19 patients. In this study, Favi DPI in the doses of 10 and 20 mg per day was compared to the oral regime of Favipiravir (1600 mg/day) along with the standard of care.
Materials and Methods: In the current randomized control trial, 64 patients with mild to moderate score of COVID-19 infection were included in three parallel groups (n = 20/group). The main outcome measures included changes in subjects getting reverse transcription polymerase chain reaction (RT-PCR) negative, alleviation of clinical symptoms, SpO2, inflammatory markers, requirement of hospital stay, and metabolic profiles.

Results: The Favi DPI groups have shown clinically significant improvement in reduction of viral titer, symptoms, and inflammatory marker levels from the baseline. The biochemical tests, hospital stay, and other safety profile were comparable to oral Favipiravir as a control. There was slightly better efficacy shown by Favi DPI 20 mg than Favi DPI 10 mg in terms of alleviation of symptoms and RT-PCR negativity.

Conclusion: All subjects from Favi DPI groups led to clinical cure and no progression of disease as observed with oral Favipiravir regime. The reduced dose can curtail the side effects of Favipiravir which can be achieved through DPI favipiravir formulation requiring many fold less dose than the oral dosage form. This study may provide link to assess superiority of Favi DPI compared to oral, in terms of reduced dosage, toxicity, improved patient compliance, and good prognosis of the disease.

Keywords: Antiviral, COVID-19, dry powder, Favipiravir

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