Serial Viral Load Analysis by Ddpcr to Evaluate Fnc Efficacy and Safety in the Treatment of Mild Cases of Covid-19

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak has threatened the human population globally as the numbers of reinfection cases even after large-scale vaccination. Trials have been carried out to find drugs effective in fighting the disease, as COVID-19 is being considered a treatable disease only after we have antivirals. A clinical candidate originally developed for HIV treatment, AZVUDINE (FNC), is a promising drug in the treatment of COVID-19, being able to reduce the patient's viral load leading to cure. To predict the clinical outcome of COVID-19, we examined the course of viral load, every 48hs, by RT-PCR, and disease severity using a promising antiviral drug, AZVUDINE (FNC) with 281 participants. A randomized clinical trial was performed to evaluate the efficacy of FNC added to standard treatment, compared with placebo group added to standard treatment, for patients with mild COVID-19. RT-qPCR and ddPCR were applied to estimate the viral load in samples from patients, which was performed every 48 hours throughout the treatment. Also, the clinical improvement was evaluated as well as the liver and kidney function. Notably, the FNC treatment in the mild COVID-19 patients may shorten the time of the nucleic acid negative conversion (NANC) versus placebo group. In addition, the FNC was effective in reducing the viral load of these participants, in the first days (D3, D5, D7, D9). Therefore, the present clinical trial results showed that the FNC accelerate the elimination of the virus in and could reduce treatment time of mild patients and save a lot of medical resources, making it a strong candidate for the outpatient and home treatment of COVID-19. Trial registration number:NCT05033145 https://clinicaltrials.gov/ct2/show/NCT05033145

A Nearly 20‐Year Journey to Success of Azvudine for Antiviral Therapy

“…In phase III clinical trial (trial number: NCT05033145), mild COVID-19 patients who received Azvudine treatment experienced a shorter NANC by an average of 2.7 d compared to those in the placebo group. [34] Compared to placebo groups, Azvudine showed good safety. The adverse reactions included headache, dizziness, AST increase, nausea, ALT increase, and D Dimer increase and were the same as those related to antiviral drugs.…”

Efficacy and safety evaluation of Azvudine in the treatment of COVID-19 based on four phase Ⅲ clinical trials.

“…The results were detailedly disclosed in the preprints published on the Research Square platform (https://www.researchsquare.com), and showed that Azvudine significantly reduced the time of nucleic acid negative conversion (NANC) as well as the viral load of the patients compared to placebo. 4,5 Taken together, Azvudine could decrease the time of NANC, viral load, and median time to improvement in clinical condition, and increase the proportion of improvement in clinical condition on day 7 in the patients with COVID-19. In addition, Azvudine exhibited good safety and well tolerance as compared to placebo.…”