COVID-19 ANtibody Responses in Cystic Fibrosis: CAR-CF
COVID-19Cystic FibrosisThe coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF has protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between sociodemographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyze end-points will be examined to explore any age-related or gender-based differences, as well as a subgroup analysis of outcomes in lung transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.
A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults
Severe Acute Respiratory Syndrome Coronavirus 2 InfectionVIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0. The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years. Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.
Acupuncture for Post COVID-19 Fatigue
AcupuncturePost COVID-19 Condition1 moreThe aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
Clinical Study on the Impact of Covid-19 Vaccine on Allogeneic Hematopoietic Stem Cell Transplantation...
Hematologic DiseasesAim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.
Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in...
Severe Acute Respiratory Infection (SARI)Influenza1 moreThis study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.
Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir
COVID-19Chronic Kidney Disease stage41 moreNirmatrelvir-ritonavir is approved for coronavirus disease 2019 (COVID-19) but not initially recommended in patients with severe renal impairment. Increasing observational data have shown the feasibility of dose-adjusted nirmatrelvir-ritonavir administration in patients with estimated glomerular filtration rate lower than 30 ml/min/1.73 m^2. The study is planned to assess the safety, clinical and virologic outcomes of early oral nirmatrevir-ritonavir treatment of COVID-19 in patients with stage 4 and 5 chronic kidney disease.
All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome...
Long Covid19Post COVID-19 Condition1 moreThe goal of this observational, prospective study is to in depth analyze the retinal microvasculature in patients with Post-COVID-19 Syndrome (PCS). The main questions it aims to answer is: Do patients with PCS show a prolonged endothelial dysfunction when compared with fully COVID-19 recovered participants? Does symptom severity in PCS patients correlate with the extend of endothelial dysfunction? Do these changes correlate with improvement in symptoms in the prospective observation?
Effectiveness of Vaccination Against COVID-19 in Brazil: Case-Control Study
COVID-19 VaccinesThe main objective of the study is to evaluate the effectiveness of the vaccine against covid-19, recommended by the national immunization program. This is a multicentric, observational, case-control study. Participants Cases with the disease will be compared to Control Participants, that is, without the disease, regarding the vaccination history for Covid-19.Complementarily, an evaluation of cellular and humoral immunity will be carried out in a sample of both case and control participants, taking into account the vaccination history.
Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray to Prevent Infection in High-risk...
COVID-19This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
eVusheld Assessment reaL wORld Effectiveness at UPMC
SARS-CoV-2COVID-19An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the University of Pittsburgh Medical Center (UPMC) Health System.