Active clinical trials for "COVID-19"

This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers 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 the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.

This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.

On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance. Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

This study will evaluate the correlation between the symptomaticity, Ct value, laboratory biomarkers associated to COVID-19 and the disease progression in hospitalized patients and outpatients with SARS-CoV2 infection diagnosed by RT-PCR assay for nasopharyngeal swab specimens in a specialized laboratory at Medellin,Colombia.

BIPGEN is a cross-sectional study on the genetics of bipolar disorder. As a subproject of BIPGEN, BIP-COVID is a cross-sectional genetics study about risks & resilience in the COVID-19 (Coronavirus disease) pandemic in bipolar disorder (BD) and healthy controls at the Medical University of Graz. Study participants with BD and controls from the well-established BIPLONG and BIPGEN studies will undergo a special BIP-COVID visit, which will include a COVID-19 specific online Lime survey about the psychological burden in the COVID-19 crisis, a COVID-19 antibody test (IgM and IgG), inflammation markers and isolation of DNA from fasting blood. Genotyping of DNA will be done with the GSA V.3 array. Genetic analyses (Polygenic Risk Scores of I. Stress or Major Depression and II. COVID-19 infection established with the programs PLINK, PRSice and R) will be used to analyze the genetic mechanisms of COVID-19 pandemic associated psychological symptoms and COVID-19 infection risk. Systems biology methods will be used to depict protective pathways against COVID-19 infection (e.g. Lithium pathways) and against COVID-19 associated psychiatric symptoms.

Investigating the potential role of Aerosolized retinoic acid, a potent Vitamin A metabolite for treating COVID-19 Anosmia and retinoic acid insufficiency .A novel approach for regaining Sense of Smell. Mahmoud ELkazzaz(1),Tamer Haydara(2), Abedelaziz Elsayed(3) ,Yousry Abo-amer(4), Hesham Attia(5), Quan Liu(6) and Amr Ahmed(7) Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China. Director of tuberculosis program Ghubera, public health department ,First health cluster ,Ministry of health ,Saudia Arabia. Very important Note: This clinical study is the first clinical study in literature (First posted August 12, 2021) which demonstrated depending on molecular findings that Vitamin A /Retinoic Acid will treat smell loss resulted by COVID-19 Recent rapidly accumulating evidences and reports indicate that partial loss of the sense of smell or even total anosmia are early markers of SARS-CoV-2 infection and frequently reported symptoms associated with the COVID-19 pandemic (Lechien J. R et al., 2020) However, the cellular mechanisms of this phenomenon are unknown. The rates of insomnia and depression were 26.45% and 9.92% in the COVID-19 patients after recovery. Therefore, finding an effective treatment for COVID-19 Anosmia is a critical point. Although, ACE2 has been identified as the principal host cell receptor of 2019-nCoV, and it is thought to play a critical role in the virus's entrance into the cell and subsequent infection, many cells can be infected by COVID-19 while also expressing little or no ACE2. Even though the COVID-19 entry receptor, angiotensin-converting enzyme 2 (ACE2), is not expressed in the receptor of olfactory neurons, or its synthesis is limited to to a minor fraction of these neurons.of these neurons, COVID-19 infection causes a loss of smell (anosmia) (Katarzyna Bilinska et al.,2021). Our recent findings showed that COVID-19 binds directly to STRA6 receptors of retinol leading to retinol depletion and retinoic acid insufficiency (M Elkazzaz et al,. 2021) . Retinoic acid insufficiency in the olfactory epithelium, both in mouse and chick models, causes progenitor cell maintenance failure and, consequently, olfactory neurons differentiation is not maintained . An explant system, showed that renewal of olfactory neurons is inhibited if retinoic acid synthesis was failed in the olfactory epithelium (Paschaki M et al., 2013) . It's worth noting that vitamin A shortage also causes olfactory and taste problems, In a study by Garrett-Laster et al., (1984), the patients had vitamin A deficiency because of malnutrition and alcoholic liver cirrhosis; they lost their sense of smell after that disorder. LaMantia and Rawson et al.,( 2007) reported that administration of retinoid acid after the damage of olfactory system motivates an immune response and produces a more quick recovery of olfactoryguided behavior. It was showed that Isotretinoin improved the significantly performance of patients in the olfactory test(Demet Kartal et al.,2017) Moreover, there is increasing evidence that retinoic acid (atRA) influences gene expression of components of renin-angiotensin system (RAS), which plays a pivotal role in the pathophysiology of essential hypertension. Retinoic acid induced ACE2 expression in different animal models. Moreover, a study suggests that topical retinoids may have applicability in promoting sinus regeneration and wound healing. In a study comparing treated and untreated nasal mucosa ,untreated regenerated mucosa showed expected changes of submucosal gland loss, basal lamina and lamina propria fibrosis and loss of cilia. Reinoic acid treatment appeared to result in better mucosal regeneration marked by less cellular atypia and fibrosis(Mendy S. Maccabee et al,. 2003).. Aerosolized retinoic acid will have an effective role in treating post COVID-19 anosmia (loss of smell) via upregulating ACE2, STRA 6 and regenerating of olfactory receptors and olfactory sensory cells and neurons.

This trial consists of three parts, Part A, Part B, and Part C, and will evaluate the safety and immunogenicity of a third booster injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and immunogenicity of a third booster injection of the monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who have received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the second dose of BNT162b2. It will also evaluate the safety and immunogenicity of a three-dose regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who have not received prior Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity of BNT162b2 (B.1.1.529) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19 vaccine-experienced participants with history of SARS-CoV-2 infection will be evaluated and contrasted with the natural immune response reached after infection with the SARS-CoV-2 Omicron variant.

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.

The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health