Effect of vitamin A supplementation on the outcome severity of COVID-19 in hospitalized patients: A pilot randomized clinical trial.

INTRODUCTION: Vitamin A is one of the vitamins that is suggested as adjuvant therapy in viral infections due to its immune enhancing role. In the present clinical trial, we intended to assess the effect of vitamin A supplementation on Coronavirus disease-2019 (COVID-19) in hospitalized patients. METHODS: The present pilot randomized controlled clinical trial was conducted on 30 hospitalized patients with COVID-19. Patients in the intervention group received 50000 IU/day intramuscular vitamin A for a maximum of two weeks. Patients in the control group continued their common treatment protocols. All participants were followed up until discharge from the hospital or death. The primary outcome of the study was time to achieve clinical response based on the six classes of an ordinal scale. Time to clinical response was calculated based on the days needed to improve two scores on the scale or patient's discharge. RESULTS: The time to clinical response was not significantly different between the two groups (7.23 ± 2.14 vs. 6.75 ± 1.85 days, respectively, p = 0.48). There was no significant difference between the groups regarding clinical response (hazard ratio: 1.76 [95% CI: 0.73, 4.26]). There were no significant differences between groups regarding the need for mechanical ventilation, duration of hospitalization, or death in the hospital. CONCLUSION: The results of this pilot clinical trial showed no benefit of vitamin A compared with the common treatment on outcome severity in hospitalized patients with COVID-19. Although the results are negative, there is still a great need for future clinical studies to provide a higher level of evidence.

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.

Factors associated with COVID-19 and its outcome in patients with rheumatoid arthritis.

OBJECTIVE: We assessed the factors associated with COVID-19, clinical manifestations, and a 30-day-prognosis of COVID-19 in a cohort of rheumatoid arthritis (RA) patients compared with the index population. METHODS: In a cross-sectional study, RA patients were followed in rheumatology clinics of Tabriz University of Medical Sciences, and a group of patients diagnosed with COVID-19 from index population were recruited. Outcomes of COVID-19 were assessed by the hospitalization rate and need to intensive care unit (ICU) and mortality. During a period of 12 weeks, 128 RA patients diagnosed with COVID-19, 760 RA control group, and 92 COVID-19 patients from index population were enrolled. RESULTS: Being female, obese, and diabetic, having pulmonary disease and chronic kidney disease (CKD), and treatment with prednisolone > 5 mg/d and TNFα inhibitors (TNFis) were independent predictors of COVID-19 in RA patients. Dyspnea, anosmia, and taste loss were more common in RA patients compared with the index population. Admission in hospital, need to ICU care, and mortality occurred in 38, 11.9, and 8.6 percent of RA patients, respectively. Although hospitalization rate in RA patients was more than the index population, there were no significant differences in need to ICU care and mortality between the two groups. CONCLUSIONS: Treatment with prednisolone and TNFis and having comorbidities including obesity, diabetes, pulmonary disease, and CKD increase the risk of COVID-19 in RA patients. Although some differences exist in the clinical manifestations of COVID-19 in RA patients and index population, prognosis of COVID-19 in RA patients is not any worse. Key Points • Being female, obese and diabetic, having pulmonary disease, chronic kidney disease (CKD), treatment with prednisolone > 5 mg/d and TNFα inhibitors (TNFis) were independent predictors of COVID-19 in RA patients. • Dyspnea, anosmia and taste loss were more common in RA patients compared with the index population. • Although COVID-19 related hospitalization was higher in RA patients than in the index population, there was no significant differences in the need to ICU care and mortality between the two groups.

Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial

Bromhexine is a potential therapeutic option in COVID-19, but no data from a randomized clinical trial has been available. The present study aimed to evaluate the efficacy of bromhexine in intensive care unit (ICU) admission, mechanical ventilation, and mortality in patients with COVID-19. Methods: An open-label randomized clinical trial study was performed in Tabriz, NorthWest of Iran. They were randomized to either the treatment with the bromhexine group or the control group, in a 1:1 ratio with 39 patients in each arm. Standard therapy was used in both groups and those patients in the treatment group received oral bromhexine 8 mg three times a day additionally. The primary outcome was a decrease in the rate of ICU admissions, intubation/ mechanical ventilation, and mortality. Results: A total of 78 patients with similar demographic and disease characteristics were enrolled. There was a significant reduction in ICU admissions (2 out of 39 vs. 11 out of 39, P = 0.006), intubation (1 out of 39 vs. 9 out of 39, P = 0.007) and death (0 vs. 5, P = 0.027) in the bromhexine treated group compared to the standard group. No patients were withdrawn from the study because of adverse effects. Conclusion: The early administration of oral bromhexine reduces the ICU transfer, intubation, and the mortality rate in patients with COVID-19. This affordable medication can easily be administered everywhere with a huge positive impact(s) on public health and the world economy. Altogether, the verification of our results on a larger scale and different medical centers is strongly recommended.

Computed tomography imaging findings in hospitalized patients with coronavirus disease 2019 (COVID-19): a descriptive study of 81 cases.

PURPOSE: Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has proven to be a diagnostic challenge. Early studies have shown that computed tomography (CT) imaging may be useful in diagnosis of these patients. We aim to report CT findings in a series of hospitalized patients. MATERIAL AND METHODS: A total of 81 patients were included in this study. All of the patients were hospitalized and had SARS-CoV-2 infection proven by molecular assay. All patients had a CT scan on the first day of admission. Imaging results were reviewed by two separate radiologists, and imaging findings were documented. RESULTS: Seventy-eight patients had abnormal CT imaging, while 3 had normal CT imaging. The sensitivity of CT in diagnosing coronavirus disease 2019 (COVID-19) was estimated to be 96%. The most common imaging finding was ground glass opacities, followed by septal thickening. Most lesions were located at the periphery and posterior of the lungs. Most lesions were multifocal, and involved the right lower lobe more frequently. Chest X-rays were normal in 38 patients, and the sensitivity of chest X-ray in diagnosing SARS-Cov-2 was 54%. CONCLUSIONS: CT scans could be used in diagnosis of patients with a high sensitivity (93%). No common imaging findings may also be seen alongside ground glass opacities, based on the degree of disease progression.

Comparison of losartan and amlodipine effects on the outcomes of patient with COVID-19 and primary hypertension: A randomised clinical trial.

BACKGROUND: Controversy exists regarding the drug selection in hypertension (HTN) management in patients with COVID-19. This study aimed to compare the effects of losartan and amlodipine in patients with primary HTN and COVID-19. METHODS: In this randomised clinical trial, hospitalised patients with COVID-19 and primary HTN were enrolled in the study. One arm received losartan, 25 mg, twice a day and the other arm received amlodipine, 5 mg per day for 2 weeks. The main outcomes were compare 30-day mortality rate and length of hospital stay. RESULTS: The mean age of patients treated with losartan (N = 41) and amlodipine (N = 39) was 67.3 ± 14.8 and 60.1 ± 17.3 years, respectively (P value = .068). The length of hospital stay in losartan and amlodipine groups was 4.57 ± 2.59 and 7.30 ± 8.70 days, respectively (P value = .085). Also, the length of ICU admission in losartan and amlodipine group was 7.13 ± 5.99 and 7.15 ± 9.95 days, respectively (P value = .994). The 30-day mortality was two and five patients in losartan and amlodipine groups, respectively (P value = .241). CONCLUSIONS: There was no priority in losartan or amlodipine administration in COVID-19 patients with primary HTN in decreasing mortality rate, hospital and ICU length stay. Further studies need to clarify the first-line anti-HTN medications in COVID-19.