Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia.

BACKGROUND: We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2. METHODS: We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO2) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO2 after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups. RESULTS: 380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO2 after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.

Daytime sleepiness and quality of sleep in patients with COPD compared to control group.

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is a widespread disease. It produces some night symptoms such as nighttime cough and dyspnea. Then subjective and objective changes in sleep pattern are expected. Present study was conducted to determine frequency of sleepiness and quality of sleep in patients with COPD. MATERIALS & METHODS: Present case-control study has been performed on 120 patients with diagnosis of COPD who had been referred to pulmonary disease clinic in a University teaching hospital. One hundred twenty age- and sex- matched healthy individuals were recruited in the study and served as control. Spirometry (PFT) was performed for all patients. Patients were categorized under 3 groups in relation to their PFT as follow: mild COPD (FEV1/FVC<70% and >=80%), moderate COPD (FEV1/FVC<70% and 50%<=FEV1<80%), and severe COPD (FEV1/FVC<70% and FEV1<50%). Pittsburgh Sleep Quality questionnaire (PSQI) and Epworth Sleepiness Scale (ESS) were used to estimate quality of sleep and daytime sleepiness in the patients and control group. The collected data were analyzed using version 16 SPSS software. Student's T- test, Chi- square and multiple logistic regressions were used as appropriated. RESULTS: 120 patients with COPD (79 males and 41 females) and 120 normal individuals responded to the questionnaires. Mean scores of quality of sleep were 8.03±3.66 and 4.2±2.8 in COPD patients and control group respectively. 32.1% of the patients had good sleep quality (PSQI score less than 5) and 67.9% had poor sleep quality. Daytime sleepiness (ESS>=10) was present in 34.8% of the patients and 15% of control people. Multiple logistic regressions showed that the patients reported significantly worse sleep quality and more daytime sleepiness than control group [OR=2.9; 95% CI (1.6-3.7) & OR=3.5; 95% CI (2.5-4.3) respectively]. CONCLUSION: Results of present study confirmed that COPD is associated with daytime sleepiness and poor quality of sleep, possibly attributable to nighttime respiratory difficulties and concomitant sleep apnea. Assessment of the patients for symptoms of sleep apnea, daytime sleepiness should be a part of regular follow up visits of patients with COPD.