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 .
The rates of extrapulmonary and disseminated TB in Oman are higher than what has been recognized. Expatriates, patients with HIV, and smokers are at high risk for disseminated TB. In these patients, suspected extrapulmonary sites should be evaluated and sampled to exclude disseminated TB.
Background Colistin is used to treat gram-negative infections but it's highly associated with nephrotoxicity. Objectives To determine the incidence and risk factors as well as mortality in patients on colistin. Setting Sultan Qaboos University Hospital, Muscat, Oman. Methods This was a retrospective cohort study of patients admitted and who received colistin for ≥ 48 h. The exclusion criteria included inhaled colistin therapy, cystic fibrosis, or pregnancy. The study period was from January 2010 to June 2016. Main outcome measures Nephrotoxicity using the Risk, Injury, Failure, Loss and Endstage kidney disease (RIFLE) criteria. The secondary outcomes were incidence, risk factors and mortality in patients on colistin. Results A total of 123 patients were included. Colistin-associated nephrotoxicity (CAN) occurred in 57 (46%) patients after colistin therapy. As per the RIFLE criteria, 22 (18%) patients were classified as 'at risk', 17 (14%) as 'injury', and 18 (15%) as 'failure'. Multivariate analysis indicated that increasing age (adjusted odds ratio (aOR), 1.03; 95% confidence interval (CI) 1.01-1.06; p = 0.004) and higher APACHE II score (aOR 1.08; 95% CI 1.01-1.16; p = 0.040) were significant predictors for the development of nephrotoxicity. Factors associated with mortality included ICU admission (aOR 23.3; 95% CI 5.04-106; p < 0.001), vasopressin use (aOR 5.54; 95% CI 1.56-19.6; p = 0.008) and higher APACHE II score (aOR 1.15; 95% CI 1.03-1.30; p = 0.027). Conclusions The incidence of CAN was 46%. Increasing age and higher APACHE II score were the risk factors for CAN. Factors associated with mortality at 28 days included ICU admission and higher APACHE II score.
To improve TB outcome in this high-risk group, abrupt clinical management approaches should be applied when TB is suspected. Public health measures that increase community awareness of TB mortality and reduce barriers to TB care are crucial to reducing TB mortality.
Background:Antiretroviral therapy (ART) adherence is crucial to achieve HIV suppression and to prolong survival of HIV-infected patients. Although monitoring of ART adherence is standard of HIV care, there is yet no optimal method to measure ART adherence. Therefore, it is essential to compare the effectiveness of different adherence measurement tools to predict HIV suppression.Methods:In this study, we measured ART adherence using pharmacy refill prescription and self-reported adherence questionnaire. Both the methods were compared for predicting HIV suppression in adult Omani HIV-infected patients attending the outpatient clinics at Sultan Qaboos University Hospital.Results:A total of 141 HIV-infected patients were included. The pharmacy refill–based measure showed a median adherence rate of 98.90% (interquartile range [IQR]: 86%-99.45%). The self-report adherence questionnaire revealed a median adherence rate of 100% (IQR: 75-100). A significant positive correlation was found between the adherence rates measured by the 2 methods (r = 0.32, P = .01). The pharmacy refill and self-report questionnaire adherence measures were both negatively correlated with plasma HIV RNA levels (r = −0.20, P = .01 and r = −0.26, P = .04, respectively).Conclusion:Collectively, these findings suggest that pharmacy refill measure could serve as a valid and practical tool of ART adherence in routine clinical practice.
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