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1.
Clin Microbiol Infect ; 28(4): 602-608, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1708470

ABSTRACT

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.


Subject(s)
COVID-19 , Adult , Amides/therapeutic use , COVID-19/drug therapy , Double-Blind Method , Humans , Male , Pyrazines/adverse effects , Treatment Outcome
2.
Front Pharmacol ; 12: 652482, 2021.
Article in English | MEDLINE | ID: covidwho-1441129

ABSTRACT

Introduction: It is well-established that clinical pharmacist-managed anticoagulation services achieve superior anticoagulation control, with a positive impact. At King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia, the structure of anticoagulation management is a pharmacist-managed specialty service. With the current COVID-19 situation, measures were taken to assure the continuity of patient care by establishing tele-pharmacy anticoagulation clinics. Materials and Methods: This was a prospective study with patients prescribed anticoagulation and followed up for 3 months. Since establishing the anticoagulation virtual clinic in March 2020, 270 patients were recruited in the study. The data collected included age, gender, comorbidities, indication for anticoagulation, intended duration of treatment, warfarin dose, testing of International Normalized Ratio (INR), INR target, range of INR values, time INR that was within the therapeutic range (TTR), and complications of therapy (bleeding and/or bruises). The patients were asked to complete the pharmacist satisfaction survey (PSS) after their consultation to assess patient satisfaction with the new virtual consultation system. Linguistic and cultural validation was conducted for the questionnaire. Results: A total of 270 patients were included in the study. The mean percentage of overall INR values in the range was 59.39% ± 32.84, and the mean time with the overall INR was within the therapeutic range 57.81% ± 32.08. Thirty-one percent of the sample had good anticoagulation control (time in therapeutic range >70%). The median satisfaction score was 32 (IQR 28-36) with a maximum score of 40. Conclusion: This is the first study to assess the tele-pharmacy anticoagulation clinic's efficiency and patient satisfaction in Saudi Arabia during the COVID-19 pandemic. This type of consultation was as effective as face-to-face consultations. The study also highlighted that though the reduction in the cost of care was not substantial, there was a significant increase in resource (clinical pharmacist) utilization as a result of this model. The adoption of tele-pharmacy resulted in time savings for the clinical pharmacists who can be utilized in many other improvement projects in adult ambulatory clinics to ensure the delivery of better quality and safe patient care.

3.
BMJ Open ; 11(4): e047495, 2021 04 14.
Article in English | MEDLINE | ID: covidwho-1186293

ABSTRACT

INTRODUCTION: A novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019. There is a lack of specific therapeutic agents based on evidence for this novel coronavirus infection; however, several medications have been evaluated as a potential therapy. Therapy is required to treat symptomatic patients and decrease the virus carriage duration to limit the communitytransmission. METHODS AND ANALYSIS: We hypothesise that patients with mild COVID-19 treated with favipiravir will have a shorter duration of time to virus clearance than the control group. The primary outcome is to evaluate the effect of favipiravir on the timing of the PCR test conversion from positive to negative within 15 days after starting the medicine.Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5 days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres. This double-blind, randomised trial comprises three significant parts: screening, treatment and a follow-up period. The treating physician and patients are blinded. Eligible participants are randomised in a 1:1 ratio to either the therapy group (favipiravir) or a control group (placebo) with 1800 mg by mouth two times per day for the first day, followed by 800 mg two times per day for 4-7 days. Serial nasopharyngeal/oropharyngeal swab samples are obtained on day 1 (5 days before therapy). On day5±1 day, 10±1 day, 15±2 days, extra nasopharyngeal/oropharyngeal PCR COVID-19 samples are requested.The primary analysis population for evaluating both the efficacy and safety outcomes will be a modified intention to treat population. Anticipating a 10% dropout rate, we expect to recruit 288 subjects per arm. The results assume that the hazard ratio is constant throughout the study and that the Cox proportional hazard regression is used to analyse the data. ETHICS AND DISSEMINATION: The study was approved by the King Abdullah International Medical Research Centre Institutional Review Board (28 April 2020) and the Ministry of Health Institutional Review Board (1 July 2020). Protocol details and any amendments will be reported to https://clinicaltrials.gov/ct2/show/NCT04464408. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: National Clinical Trial Registry (NCT04464408).


Subject(s)
Amides/therapeutic use , COVID-19/drug therapy , Pyrazines/therapeutic use , Adult , Female , Humans , Male , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Treatment Outcome
4.
Front Psychiatry ; 11: 619540, 2020.
Article in English | MEDLINE | ID: covidwho-1058465

ABSTRACT

Objectives: The study aimed to assess the mental health outcomes and associated factors among health care workers during COVID 19 in Saudi Arabia. Design, Setting, and Participants: We conducted a cross-sectional survey of health care workers from tertiary care and ministry of health Centers across the Central, Eastern, and Western regions of Saudi Arabia. There were 1,130 participants in the survey, and we collected demographic and mental health measurements from the participants. Primary Outcomes and Measures: The magnitude of symptoms of depression, anxiety, and insomnia was measured using the original version of 9-item patient health questionnaire (PHQ-9), the 7-item generalized anxiety disorder scale (GAD-7), and 7-item insomnia severity index (ISI). We use the multiple logistic regression analysis to identify the associated risk factors of individual outcomes. Results: The scores on the PHQ-9 showed that the largest proportion of health care workers (76.93%) experienced only normal to mild depression (50.83 and 26.1%, respectively). The scores on the GAD-7 showed that the largest proportion of health care workers (78.88%) experienced minimal to mild anxiety (50.41 and 28.47%, respectively). The scores on the ISI showed that the largest proportion of health care workers (85.83%) experienced absence to subthreshold insomnia (57.08 and 28.75%, respectively). The risk factors for depression in health care workers were Saudi, living with family, working from an isolated room at home and frontline worker. For anxiety, being female was risk factor and for insomnia, being frontline worker was risk factor. Conclusion: It was observed that the symptoms of depression, anxiety, and insomnia were reported in a lower proportion of health care workers in our study. The participants who were female, frontline workers, Saudi, living with family, and working from home in isolated rooms were predisposed to developing psychological disorders.

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