Efficacy of favipiravir in adults with mild COVID-19: a randomized, double-blind, multicentre, placebo-controlled clinical trial.

OBJECTIVE: To evaluate whether favipiravir reduces the time to viral clearance as documented by negative RT-PCR results for severe acute respiratory syndrome coronavirus 2 in mild cases of coronavirus disease 2019 (COVID-19) compared to placebo. METHODS: In this randomized, double-blinded, multicentre, 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 1 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, intensive care unit admissions, adverse events, and 28-day mortality. RESULTS: Two hundred thirty-one patients were randomized and began the study (median age, 37 years; interquartile range (IQR): 32-44 years; 155 [67%] male), and 112 (48.5%) were assigned to the treatment group and 119 (51.5%) into the placebo group. The data and safety monitoring board recommended stopping enrolment because of futility at the interim analysis. The median time to viral clearance was 10 days (IQR: 6-12 days) in the favipiravir group and 8 days (IQR: 6-12 days) in the placebo group, with a hazard ratio of 0.87 for the favipiravir group (95% CI 0.571-1.326; p = 0.51). The median time to clinical recovery was 7 days (IQR: 4-11 days) in the favipiravir group and 7 days (IQR: 5-10 days) in the placebo group. There was no difference between the two groups in 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.

Correlation of intraoperative donor duodenal-segment swab cultures with the subsequent occurrence of surgical site infections in kidney and pancreas transplant recipients.

BACKGROUND: Pancreas transplantation is employed for the treatment of type I diabetes mellitus. It is postulated that surgical site infection (SSI), particularly organ-space infections, after pancreas transplantation may arise from microbial contamination arising from the donor duodenal segment. Therefore, some centers have adopted the practice of culturing the donor duodenal segment and subsequently administering antimicrobial therapy to the recipient directed at the microorganisms isolated to prevent SSI. METHODS: In this retrospective cohort study, we evaluated the correlation between positive donor duodenal-segment cultures and SSIs in the recipients. Data were recorded and analyzed to assess the correlation of the organisms isolated in the donor duodenal cultures with those producing SSI in the recipients. RESULTS: We evaluated 379 consecutive pancreas transplant recipients from January 2000 to December 2015. Donor duodenal swab cultures were performed at the time of pancreas transplantation, and 206 (54.3%) were positive. SSIs occurred in 51 of the 206 recipients (24.8%) with positive duodenal-segment cultures and in 41 of 173 individuals (23.7%) with negative cultures (P = .81; r = 0.00). Notably, deep and organ-space SSIs were observed in 27 of 206 of the positive duodenal culture groups (13.1%) versus 29 of 173 of the negative duodenal culture groups (16.8%; P = 0.31; r = -0.059). No differences were detected in the pathogens producing SSIs between the group with a positive duodenal swab versus the group with a negative swab. Microorganisms producing SSIs matched those found in the positive donor duodenal cultures in only 15 patients (7.8%). CONCLUSION: Although positive cultures from the donor duodenal segment prompted the administration of antimicrobial therapy in the recipient directed against the pathogen isolated, this practice did not reduce SSIs compared with those transplant recipients with culture-negative duodenal swabs. In addition, the organisms isolated from the donor duodenal segment were not predictive of subsequent SSI.