ImportanceThe protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown.ObjectiveTo evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults.Design, Setting, and ParticipantsA multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021.InterventionsIn cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection.Main Outcomes and MeasuresThe primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed.ResultsIn cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths.Conclusions and RelevanceIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19–related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price.Trial Registrationisrctn.org Identifier: IRCT20210303050558N1
Introduction: As one of the most common causes of human morbidity and mortality, chronic obstructive pulmonary disease (COPD) affects millions around the world. Some evidences have already considered about association between serum levels of vitamin D and COPD. Objectives: This study was aimed to evaluate the effects of vitamin D supplementation on COPD improvement. Patients and Methods: This study was designed as a randomized controlled trial. Forty COPD patients with vitamin D deficiency were enrolled into two groups; cases group who administered vitamin D and control group who received placebo. The severity of dyspnea and spirometric indices were analyzed in both groups. Values were presented as mean and standard deviation (SD) and differences were considered significant at the level of P<0.05. Results: Spirometric indices did not show significant differences before and after vitamin D administration (P>0.05). Dyspnea severity was significantly improved after receiving vitamin D supplementation in comparison with placebo consumption (P=0.03). Conclusion: Spirometric indices were not affected during vitamin D supplementation therapy but it showed a significantly positive effect on the curing of dyspnea. Therefore, adjuvant therapy of COPD using vitamin D supplementation is recommended to better handling of dyspnea in COPD cases.
The novel corona virus infection involve both Central & Peripheral Nervous System . Some of the presentations include: acute cerebrovascular disease, impaired consciousness, transverse myelitis, encephalopathy, encephalitis and epilepsy. Our patient was 78 year –old man with dementia and diabetic nephropathy which was admitted two times for possibly COVID19 infection. At the first hospitalization, the patient is treated with hydroxychloroquine and kaletra based on clinical symptoms and initial laboratory findings due to suspicion of COVID19 . After the negative RT-PCR test of nasopharyngeal sample for covid19 and evidence of aspiration pneumonia in CT scan, the patient was discharged with oral antibiotics. Five weeks later, he was rehospitalized with loss of consciousness, fever and hypoxemia in physical exam he had neck stiffness in all directions, So the CNS infection was suspected, the CSF sample was in favor of aseptic meningitis and second RT-PCR test of nasopharyngeal sample for COVID19 was positive but Brain MRI just showed small vessel disease without evidence of encephalitis. In the second hospitalization, he had acute renal failure, which was treated with supportive care, and also suffered from pulmonary embolism with cavitary lesions in his lungs. Meningitis with pulmonary embolism and acute renal failure have not yet reported. Our patient is the first one, so we decided to share it. This case showed different presentation of COVID19 without typical lung involvement. So we must pay attention to any sign & symptoms in a patient suspected of having a COVID19 .
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