Objective
To evaluate whether favipiravir reduces the time to viral clearance as documented by negative SARS-CoV-2 RT-PCR in mild COVID-19 cases compared to placebo.
Methods
In this randomized, double-blinded, multicenter, and placebo-controlled trial, adults with PCR confirmed mild COVID-19 were recruited in an outpatient setting at seven medical facilities across Saudi Arabia. Participants were randomized in a 1:1 ratio to receive either favipiravir 1800 mg by mouth twice daily on day one followed by 800 mg twice daily (n=112) or a matching placebo (n=119), for a total of 5 to 7 days. The primary outcome was the effect of favipiravir on reducing the time to viral clearance (by PCR test) within 15 days of starting the treatment compared to the placebo group. The trial included the following secondary outcomes: symptom resolution, hospitalization, ICU admissions, adverse events, and 28-day mortality.
Results
231 patients were randomized and began the study (median age, 37 [interquartile range: 32-44] years; 155 [67%] men), and 112 (48.5%) were assigned to the treatment group and 119 (51.5%) into the placebo group. The data and safety monitoring board (DSMB) recommended stopping enrollment because of futility at the interim analysis. The median time to viral clearance was 10 (IQR: 6-12) days in the favipiravir group and 8 (IQR: 6-12) days in the placebo group, with a hazard ratio of 0.87 for the favipiravir group (95% CI 0.571 to 1.326; p-value =0.51). The median time to clinical recovery was 7 days (IQR: 4-11) in the favipiravir group and 7 days (IQR: 5-10) in the placebo group. There was no difference between the two groups on the secondary outcome of hospital admission. There were no drug-related severe adverse events.
Conclusion
In this clinical trial, favipiravir therapy in mild COVID-19 patients did not reduce the time to viral clearance within 15 days of starting the treatment.
Clinical Trial Registration
ClinicalTrials.gov identifier (
NCT04464408
):
https://clinicaltrials.gov/ct2/show/NCT04464408
.
Background
Antimicrobial resistance constitutes a major public health issue that leads to poor outcomes and increased costs associated with healthcare. Solid organ transplant recipients are more prone due to prolonged exposure to antimicrobials.
Methods
We reviewed existing programs in the Kingdom of Saudi Arabia and pattern of drug resistance, and the extent of transplant medicine in the kingdom through published articles in databases and official documents from health authorities.
Results
A national committee for antimicrobial resistance (AMR) was established to set the guidelines required for an antimicrobial stewardship program (ASP), especially when there is a high prevalence of AMR. A survey noted that ASPs are implemented in only 26% of Saudi Ministry of Health hospitals. Factors affecting the implementation of ASPs in Saudi hospitals included a lack of necessary staff resources and specific ASP staff/teams to advocate adopting ASP in the organizations. Specific attention should be given to transplant patients as transplantations are expected to increase in the next few years. No antimicrobial stewardship programs are currently specifically tailored to transplant centers.
Conclusion
The current healthcare system transformation in Saudi Arabia should take into consideration the urgent need for effective ASP that might help face the increasing trends in the multidrug‐resistant organisms (MDRO) prevalence rate.
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