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Covid19 clinical trials

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NCT ID: NCT04934111 Recruiting - COVID-19 Clinical Trials

Safety and Immunogenicity of LNP-nCOV saRNA-02 Vaccine Against SARS-CoV-2, the Causative Agent of COVID-19

COVAC-Uganda
Start date: December 2, 2021
Phase: Phase 1
Study type: Interventional

COVAC Uganda is a study that is looking at the use of an innovative self-amplifying RNA (saRNA) vaccine (LNP-nCOV saRNA-02) against the virus (SARS-CoV-2) that causes COVID-19 and assessing the immune response in SARS-CoV-2 antibody seronegative and seropositive individuals. saRNA is designed to amplify the quantity of RNA upon injection to produce further antigen, thereby enabling lower doses for administration. In the trial "COVAC1", Imperial College London is currently evaluating one COVID-19 saRNA vaccine candidate in doses from 0.1-10ug for individuals who are seronegative for SARS-CoV-2 antibodies at baseline. Interim analyses of COVAC1 has shown a dose dependent response; however, up to 50% of seronegative participants receiving doses of 2.5-10ug do not seroconvert. The investigators hypothesize that a lack of seroconversion is due to type I and III interferon (IFN) production, which can inhibit translation and degrade cellular mRNA. Another variable that can enhance antibody production is serological history: recent studies have shown that seropositive individuals respond significantly better than naïve individuals who received the Pfizer or Moderna RNA-based COVID-19 vaccine. Therefore, designing the saRNA backbone to dampen IFN production and evaluating this in individuals seropositive at baseline will inform the optimised use of this innovative technology. In COVAC Uganda, the investigators aim to test an saRNA vaccine modified to dampen the activation of type I and III IFN, to increase antibody production, for individuals who are seronegative and seropositive for SARS-CoV-2 antibodies at baseline, to evaluate whether people with pre-existing seropositivity have enhanced immune responses compared to those without. This trial is NOT looking at whether or not the vaccine is effective in terms of protection. It is just assessing whether and how well the immune system responds based on SARS-CoV-2 antibodies at baseline and its safety.

NCT ID: NCT04933799 Recruiting - COVID-19 Pneumonia Clinical Trials

IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.

Start date: January 6, 2021
Phase: Phase 2
Study type: Interventional

The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state and improving outcomes in severe COVID-19.

NCT ID: NCT04932954 Recruiting - Covid19 Clinical Trials

Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study

Start date: January 1, 2020
Phase:
Study type: Observational

This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically.

NCT ID: NCT04932876 Recruiting - Covid19 Clinical Trials

The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19

Start date: April 24, 2021
Phase:
Study type: Observational

Observational study of patients with End Stage Kidney Disease on dialysis and Kidney Transplant Recipients, before and after vaccination for SARS-COV 2, after written consent, with the aim of laboratory efficacy of the vaccine and safety regarding the clinical outcome of patients and possible complications.

NCT ID: NCT04931238 Recruiting - COVID-19 Clinical Trials

Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)

Start date: January 20, 2021
Phase: Phase 2
Study type: Interventional

The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.

NCT ID: NCT04930978 Recruiting - Clinical trials for COVID-19 Respiratory Infection

Effect of SARS-CoV-2 Disease on Immune Responses, Disease Severity and Treatment Outcomes in Pulmonary Tuberculosis

COVID-19-TB
Start date: June 21, 2021
Phase:
Study type: Observational

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the Coronavirus disease (COVID-19). Tuberculosis (TB) is the foremost cause of infectious deaths globally. In 2025, an additional 1.4 million TB deaths could occur as direct consequence of the COVID-19 pandemic. It is postulated that individuals with latent or active TB are more susceptible to SARS-CoV-2 disease and that COVID-19 disease rate is high in patients with active TB, although the evidence is still scarce. TB and SARS-CoV-2 are both infectious diseases which primarily attack the alveolar region of the lungs and share common symptoms. SARS-CoV-2 disease can induce innate and adaptive immunity, but uncontrolled inflammatory innate immunity and impaired adaptive immune responses may be associated with severe tissue damage, both locally and systemically. People with coinfection (COVID-19 and TB disease) might potentially have impaired protective immune responses and treatment outcomes, specifically as far as anti-tuberculosis treatment is concerned. However, very little is known about the immunological underpinnings in this interface between TB and COVID-19 on the effect of SARS-CoV-2 disease on disease severity, response to treatment and treatment outcomes in pulmonary tuberculosis. Investigators hypothesize that altered immunity due to prior or present asymptomatic disease with SARS-CoV-2 virus can lead to altered immune responses and systems biology, increased severity and altered treatment outcomes in TB disease. The main objective of the study would be to evaluate the baseline differences in immune cells populations immune cell responses at baseline and at the time of treatment (2nd month) and end of treatment. Further, Investigators would be evaluating the changes in proteomic profiles in a subset of these individuals. In addition, immunological assays examining differences in T cell populations, measuring levels of various cytokines and by immunophenotyping as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross-talk between active TB patients with or without SARS-CoV-2. The secondary objective would be to study the clinical features, disease severity, mycobacterial burden and treatment outcomes in a cohort of SARS-CoV-2 infected (asymptomatic PCR or Antibody+) and non-infected patients with active pulmonary TB.

NCT ID: NCT04930874 Recruiting - COVID-19 Pneumonia Clinical Trials

Cerebral Autoregulation and COVID-19

CA-COVID
Start date: June 22, 2021
Phase: N/A
Study type: Interventional

This study aims to assess cerebral autoregulation by near-infrared spectroscopy (NIRS) in patients with severe coronavirus disease 19 (COVID-19). Results on COVID-19 participants will be compared with prior results of patients with septic shock and cardiac arrest, who participated in NCT03649633 and NCT02790788, respectively.

NCT ID: NCT04930757 Recruiting - Covid19 Clinical Trials

Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

NeutroVID
Start date: February 4, 2021
Phase:
Study type: Observational

The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

NCT ID: NCT04930120 Recruiting - Covid19 Clinical Trials

Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units

TRANSCOV
Start date: March 1, 2021
Phase:
Study type: Observational

The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

NCT ID: NCT04927936 Recruiting - Covid19 Clinical Trials

A Trial Among HealthCare Workers (HCW) Vaccinated With Janssen Vaccine: the SWITCH Trial

SWITCH
Start date: June 25, 2021
Phase: N/A
Study type: Interventional

The key objective of the study is to measure the immune response against SARS-CoV-2 after different vaccinations in Health Care Workers (HCW) from 18 to 65 years old vaccinated once with Janssen vaccine. Determination of antibodies by a quantitative immunoglobulin G (IgG) assay (LIAISON SARS-CoV-2 TRIMERICS IgG essay) 28 days after second vaccination (booster) comparing, per protocol, the following three groups: 1. Janssen vaccine/- vs. Janssen vaccine/Janssen vaccine 2. Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Pfizer vaccine 3. Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Moderna vaccine