Favipiravir in the treatment of patients with SARS-CoV-2 RNA recurrent positive after discharge: A multicenter, open-label, randomized trial

Int Immunopharmacol. 2021 Aug:97:107702. doi: 10.1016/j.intimp.2021.107702. Epub 2021 Apr 21.

Abstract

Background: The clinical characteristics and treatment of patients who tested positive for COVID-19 after recovery remained elusive. Effective antiviral therapy is important for tackling these patients. We assessed the efficacy and safety of favipiravir for treating these patients.

Methods: This is a multicenter, open-label, randomized controlled trial in SARS-CoV-2 RNA re-positive patients. Patients were randomly assigned in a 2:1 ratio to receive either favipiravir, in addition to standard care, or standard care alone. The primary outcome was time to achieve a consecutive twice (at intervals of more than 24 h) negative RT-PCR result for SARS-CoV-2 RNA in nasopharyngeal swab and sputum sample.

Results: Between March 27 and May 9, 2020, 55 patients underwent randomization; 36 were assigned to the favipiravir group and 19 were assigned to the control group. Favipiravir group had a significantly shorter time from start of study treatment to negative nasopharyngeal swab and sputum than control group (median 17 vs. 26 days); hazard ratio 2.1 (95% CI [1.1-4.0], p = 0.038). The proportion of virus shedding in favipiravir group was higher than control group (80.6% [29/36] vs. 52.6% [10/19], p = 0.030, respectively). C-reactive protein decreased significantly after treatment in the favipiravir group (p = 0.016). The adverse events were generally mild and self-limiting.

Conclusion: Favipiravir was safe and superior to control in shortening the duration of viral shedding in SARS-CoV-2 RNA recurrent positive after discharge. However, a larger scale and randomized, double-blind, placebo-controlled trial is required to confirm our conclusion.

Keywords: COVID-19; Favipiravir; Recurrent positive; SARS-CoV-2.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Amides / administration & dosage*
  • Amides / adverse effects
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects
  • COVID-19 / blood
  • COVID-19 Drug Treatment*
  • Female
  • Humans
  • Lymphocyte Subsets / drug effects
  • Male
  • Middle Aged
  • Patient Discharge
  • Pyrazines / administration & dosage*
  • Pyrazines / adverse effects
  • RNA, Viral / analysis
  • RNA, Viral / drug effects
  • Reinfection / blood
  • Reinfection / drug therapy*
  • SARS-CoV-2 / drug effects
  • Treatment Outcome

Substances

  • Amides
  • Antiviral Agents
  • Pyrazines
  • RNA, Viral
  • favipiravir