Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.

This study investigates the possible adverse effects and effectiveness of convalescentplasma for patients infected with SARS-CoV-2. Following provision of informed consent,patients will be randomized into three groups: High-titre convalescent plasma, low-titreconvalescent plasma or placebo. Primary outcomes of the study will cover safety andeither intubation or initiation of systemic corticosteroids. Safety information collectedwill include serious adverse events judged to be related to administration ofconvalescent plasma. Microbiological and other laboratory parameters will be followed up.

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.

This study will collect information on immune response and adverse events aftervaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort.Understanding the ability or disability to mount a protective immune response aftervaccination will help to counsel patients during the pandemic and support decisions onwhom to vaccinate and to identify patients who require other measures to protect themfrom COVID-19.

Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in theworld, especially in terms of health system capacity and economic burden. People fromsub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus(HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIVinfection and anti-retroviral treatment (ART) in altered cardiovascular risk isquestionable and there is still need to further carry out research in this field.However, thus far it is unclear, what impact the COVID-19 co-infection in people livingwith HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims toinvestigate whether and how HIV-infection in COVID-19 patients modulates the time courseof the disease, alters cardiovascular risk, and changes vascular endothelial function andcoagulation parameters/ thrombosis risk.Methods: In this long-term study, cardiovascular research on PLHIV with or without ARTwith COVID-19 and HIV-negative with COVID-19 will be carried out via clinical andbiochemical measurements for cardiovascular risk factors and biomarkers of cardiovasculardisease (CVD). Vascular and endothelial function will be measured by brachial arteryflow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, andretinal blood vessel analyses, along with vascular endothelial biomarkers andcoagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with orwithout ART and its role in enhancement of cardiovascular risk and endothelialdysfunction will be assessed. Potential changes in these endpoints by COVID-19 will befollowed for 4 weeks across the three groups (PLHIVwith or without ART and HIVnegatives).Impact of project: The ENDOCOVID project aims to evaluate in the long-term thecardiovascular risk and vascular endothelial function in PLHIV thus revealing animportant transitional cardiovascular phenotype in COVID-19.

A multicenter, randomized, double-blind, placebo-controlled trial for hospitalizedmoderate COVID-19 patients

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by nopopulation-based immunity to the severe acute respiratory disease coronavirus 2(SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigatethe pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europethrough conditional marketing authorisation granted by the European Medicines Agency andfurther vaccine will be licensed. These vaccines have shown good vaccine efficacy inphase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccinationwith the primary aim of comparing the immune responses after COVID-19 vaccination andnatural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health careworkers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees.Demographic, clinical data and repeated blood samples will be collected to evaluate thecomplications and kinetics, duration and breadth of the immune responses comparingnatural infection to vaccination.

The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry(C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinatedduring pregnancy with a COVID-19 vaccine.Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneousabortion, antenatal bleeding, gestational diabetes, gestational hypertension,intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture,placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes(major congenital malformations, low birth weight, neonatal death, neonatalencephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth,respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19),and infant outcomes (developmental milestones [motor, cognitive, language,social-emotional, and mental health skills], height, weight, failure to thrive, medicalconditions during the first 12 months of life, COVID-19) among pregnant women exposed tosingle (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 daysprior to the first day of the last menstrual period to end of pregnancy and theiroffspring relative to a matched reference group who received no COVID-19 vaccines duringpregnancy.

This is a prospective cohort study of pregnant patients at an urban academic centerdiagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

A randomized, double-blind, placebo-controlled international multicenter clinical trialdesign will be adopted. A total of 29,000 subjects aged 18 years and above are planned tobe recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years andabove in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years andabove will be recruited outside China. Safety and immunogenicity will be evaluated amongthe Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among thesubjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 andabove from outside China and all subjects from China will be selected as theimmunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2neutralizing antibody and RBD protein binding antibody will be detected by blood samplingbefore vaccination, 14 days and 6 months after full course of vaccination to evaluate theimmunogenicity and immune persistence.