Background We evaluated clinical effectiveness of regdanvimab (CT-P59), a SARS-CoV-2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate COVID-19, primarily alpha variant. Methods This was phase 3 of a phase 2/3 parallel-group, double-blind, randomized clinical trial. Outpatients with mild-to-moderate COVID-19, were randomized to single dose regdanvimab 40 mg/kg (n = 656) or placebo (n = 659), alongside standard-of-care. Primary endpoint: COVID-19 disease progression (clinical symptoms requiring hospitalization or oxygen therapy, or mortality) up to day 28 among “high risk” patients. Key secondary endpoints: disease progression (all randomized patients) and time to recovery (high-risk and all randomized patients). Results Of 1315 patients randomized to regdanvimab or placebo, 880 were high risk (regdanvimab, n = 446; placebo, n = 434); the majority (regdanvimab, n = 371; placebo n = 381) were infected with alpha variant. The proportion with disease progression was lower (14/446 [3.1%; 95% CI, 1.9–5.2] vs. 48/434 [11.1%; 95% CI, 8.4–14.4]; P < 0.001) and time to recovery was shorter (median, 9.27 days [95% CI, 8.27–11.05] vs. not reached [95% CI, 12.35–not calculable]; P < 0.001) with regdanvimab than placebo. Consistent improvements were seen in all randomized and non–high-risk patients who received regdanvimab. Viral load reductions were more rapid with regdanvimab. Infusion-related reactions occurred in 11/1302 patients (4/652 [0.6%] regdanvimab, 7/650 [1.1%] placebo). Treatment-emergent serious adverse events were reported in 5/1302 patients (4 [0.6%] regdanvimab, 1 [0.2%] placebo). Conclusions Regdanvimab was an effective treatment for patients with mild-to-moderate COVID-19, significantly reducing disease progression and clinical recovery time without notable safety concerns prior to the emergence of the omicron variant. Trial registration ClinicalTrials.gov identifier, NCT04602000; EudraCT number, 2020-003369-20

Inflammatory bowel diseases represent a complex array of diseases of incompletely known etiology that led to gastrointestinal tract chronic inflammation. In inflammatory bowel disease, a promising method of treatment is represented by fecal microbiota transplantation (FMT), FMT has shown its increasing effectiveness and safety in recent years for recurrent CDI; moreover, it showed real clinical benefits in treating SARS-CoV-2 and CDI co-infection. Crohn’s disease and ulcerative colitis are characterized by immune dysregulation, resulting in digestive tract damage caused by immune responses. Most current therapeutic strategies are associated with high costs and many adverse effects by directly targeting the immune response, so modifying the microbial environment by FMT offers an alternative approach that could indirectly influence the host’s immune system in a safe way. Studies outline the endoscopic and clinical improvements in UC and CD in FMT patients versus control groups. This review outlines the multiple benefits of FMT in the case of IBD by improving patients unbalanced gut, therefore improving endoscopic and clinical symptomatology. We aim to emphasize the clinical importance and benefits of FMT in order to prevent flares or complications of IBD and to highlight that further validation is needed for establishing a clinical protocol for FMT in IBD.

BackgroundIn the context of an increase number of primary and revision total hip and total knee arthroplasty performed yearly, an increased risk of complication is expected. Prosthetic joint infection (PJI) remains the most common and feared arthroplasty complication. Ralstonia pickettii is a Gram-negative bacterium, that has also been identified in biofilms. It remains an extremely rare cause of PJI. There is no report of an identification of R. pickettii on an extracted spacer loaded with antibiotic.Case presentationWe present the case of an 83-years-old Caucasian male patient, that underwent a right cemented total hip replacement surgery. The patient is diagnosed with an early PJI with no isolated microorganism. A debridement and change of mobile parts is performed. At the beginning of 2016, the patient in readmitted into the Orthopedic Department for sever, right abdominal and groin pain and elevated serum erythrocyte sedimentation rate and C-reactive protein. A joint aspiration is performed with a negative microbiological examination. A two-stage exchange with long interval management is adopted, and a preformed spacer loaded with gentamicin was implanted. In July 2016, based on the proinflammatory markers evolution, a shift a three-stage exchange strategy is decided. In September 2016, a debridement, and changing of the preformed spacer loaded with gentamicin with another was carried out. Bacteriological examination of the tissues sampled intraoperatively was positive for Pseudomonas aeruginosa. From the sonication fluid, no bacteria were isolated on culture or identified using the bbFISH assay. During the hospitalization period, the patient received i.v. ceftazidime 3x2g/day and p.o. ciprofloxacin 2x750mg/day, antibiotic therapy that was continued after discharge with p.o. ciprofloxacin 2x750mg/day for 6 weeks. In February 2017, a reimplantation of a revision prosthesis is performed. The retrieved spacer is sonicated, and after 4 days of incubation of the sonication fluid, R. pickettii is isolated. A long term antibiotic therapy with cotrimoxazole being prescribed.ConclusionsBacteria culture of sonication fluid remains the gold standard in diagnosing prosthetic joint infections. R. pickettii remains an extremely rare cause of prosthetic joint infection. Optimal management of R. pickettii prosthetic joint infections of has not been established.

Rationale: Pityriasis rosea Gibert is an erythematous-papulosquamous dermatosis that frequently occurs in young adults. The etiopathogenesis of PR is still unknown, but is frequently associated with episodes of upper respiratory tract infections. It is likely that a new viral trigger of pityriasis rosea is the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patient concerns: We present the case of a female patient in whom the diagnosis of pityriasis rosea led to the investigation and diagnosis of the SARS-CoV-2 infection. The patient presented to the Department of Dermatology for a 3 week duration of an extremely pruritic erythematous-squamous lesion, initially on the trunk and upper limbs, with extension to the lower limbs in the last week and the lesion respected the cephalic extremity, palms, and soles. One week before the rash, respiratory tract infection symptomatology was observed by the patient. At home, she underwent systemic treatment with antihistamines and topical medication with dermatocorticosteroids. The evolution was unfavorable, with the spread of the lesions and the accentuation of the pruritus. Diagnoses: Considering the actual epidemiological context, we performed a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay from nasal and pharyngeal swabs for coronavirus disease 2019 (COVID-19) to investigate the PR etiology. The patient had a positive RT-PCR result, and was confirmed with SARS-CoV-2 infection. Interventions: Treatment was initiated with systemic corticosteroid therapy - hydrocortisone hemisuccinate 200 mg/day for 7 days, and loratadine 10 mg 2 times a day. Also, topical medication with dermatocorticosteroids and emollients was associated. Outcome: Under the treatment that was initiated a partial remission of the lesions after 7 days was observed. Lessons: Our reported case adds to the other findings regarding the association of PR with SARS-CoV-2 infection, in the context of the pandemic, suggesting the need to test patients with PR skin lesions for SARS-CoV-2 infection.

The third dose of the HPV-16/18 vaccine can be administered any time between 6 and 12 months after the first dose, with adequate immunogenicity and a clinically acceptable safety profile.