Name (Synonyms) | Correlation | |
---|---|---|
drug287 | BCG-Denmark Wiki | 0.38 |
drug489 | COVID19 vaccine Wiki | 0.38 |
drug982 | GX-19 Wiki | 0.38 |
drug1773 | Patient management suffering of coronavirus infection Wiki | 0.38 |
drug1538 | N-803 Wiki | 0.38 |
drug1785 | Peginterferon lambda alfa-1a subcutaneous injection Wiki | 0.38 |
drug736 | Degarelix Wiki | 0.38 |
drug1667 | Observational Study Wiki | 0.38 |
drug2933 | online mindfulness group Wiki | 0.38 |
drug1077 | Human biological samples Wiki | 0.38 |
drug647 | Convalescent Plasma Wiki | 0.08 |
Name (Synonyms) | Correlation | |
---|---|---|
D009877 | Endophthalmitis NIH | 0.38 |
D002481 | Cellulitis NIH | 0.38 |
D054517 | Orbital Cellulitis NIH | 0.38 |
D000077062 | Burnout, Psychological NIH | 0.11 |
D013315 | Stress, Psychological NIH | 0.08 |
D007239 | Infection NIH | 0.06 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
D018352 | Coronavirus Infections NIH | 0.05 |
D055371 | Acute Lung Injury NIH | 0.04 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
D003141 | Communicable Diseases NIH | 0.03 |
D011014 | Pneumonia NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0100658 | Cellulitis HPO | 0.38 |
HP:0002090 | Pneumonia HPO | 0.02 |
There are 7 clinical trials
This is a phase 2b prospective, randomized, single-blind, controlled trial of two weekly subcutaneous injections of lambda interferon alfa-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.
Description: No evidence of SARS-CoV-2 infection at or before study day 28
Measure: Proportion of participants with no evidence of SARS-CoV-2 infection Time: Up to 28 daysDescription: Resolution of SARS-CoV-2 infection in the upper respiratory tract
Measure: Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples Time: Up to 14 daysThe overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Description: Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Measure: Number of patients with disease progression Time: 15 daysDescription: This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. 8 = Death 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 6 = Hospitalized, intubated and mechanically ventilated 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula 4 = Hospitalized on supplemental oxygen by mask or nasal prongs 3 = Hospitalized not on supplemental oxygen 2 = Not hospitalized with limitation in activity (continued symptoms) 1 = Not hospitalized without limitation in activity (no symptoms)
Measure: Worst severity rating on the WHO COVID Ordinal Scale for Clinical Improvement during the 30 days following randomization Time: 30 daysDescription: Time to disease progression on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale 1 = patient requires care in the hospital 2 = patient requires care in the ED or urgent care 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain) 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness 5 = patient in their usual state of health
Measure: Time to disease progression Time: 15 daysBackground: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW constitute 20% of all the COVID-19 cases in Denmark. Strategies to prevent absenteeism of HCW are urgently needed. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified. We hypothesize that BCG vaccination can reduce HCW absenteeism during the COVID-19 pandemic. Primary objective: To reduce absenteeism among HCW with direct patient contacts during the COVID-19 epidemic. Secondary objective: To reduce the number of HCW that are infected with SARS-CoV-2 during the COVID-19 epidemic and to reduce the number of hospital admissions amongst HCW with direct patient contacts during the COVID-19 epidemic. Study design: A multi-center randomized placebo controlled trial. Study population: 1500 HCW with direct patient contacts; defined as nurses, physicians and other medical staff working at emergency rooms and wards where COVID-infected patients are treated. Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline). Main study parameters/endpoints: Primary endpoint: Number of days of (unplanned) absenteeism for any reason. Secondary endpoints: Number of days of (unplanned) absenteeism because of documented COVID infection. Cumulative incidence of hospital admissions. Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the potential beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of COVID infection.
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Preliminary safety and efficacy evaluation of N-803 by adverse event (AE) incidence Time: 2 weeksDescription: The 7-point ordinal scale is an assessment of the clinical status and is performed as the first assessment on each study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Preliminary safety and efficacy evaluation of N-803 by subject clinical status using a the 7-point ordinal scale. Time: 2 weeksDescription: National Early Warning Score (NEWS) is based on 7 clinical parameters: respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness.
Measure: Further evaluate efficacy of N-803 using changes to the National Early Warning Score (NEWS) Time: 2 weeksThe purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.
Description: Determine if degarelix + best supportive care (BSC) as compared to placebo + BSC reduces the composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 15 after randomization.
Measure: A composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 15 after randomization. Time: 15 daysDescription: Determine if degarelix + BSC as compared to placebo + BSC reduces time to clinical improvement as defined by a decline of 2 categories or more from the baseline on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge whichever comes first.
Measure: Time to clinical improvement Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + BSC as compared to placebo + BSC reduces inpatient mortality.
Measure: Inpatient mortality Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + BSC as compared to placebo + BSC shortens the duration of hospitalization.
Measure: Duration of hospitalization Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + BSC as compared to placebo + BSC shortens the duration of intubation for mechanical ventilation.
Measure: Duration of intubation for mechanical ventilation. Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + BSC as compared to placebo + BSC reduces the time to normalization of temperature (T < 37.5 for 48 hours)
Measure: Time to normalization of temperature. Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + BSC as compared to placebo + BSC reduces the maximum severity of COVID-19 illness based on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. Score range 1-7, higher scores equals worse outcome.
Measure: Maximum severity of COVID19 illness. Time: Through study completion/discharge (an average of 30 days with a maximum of 4 months)Description: Determine if degarelix + best supportive care (BSC) as compared to placebo + BSC reduces the composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 30 after randomization.
Measure: A composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 30 after randomization. Time: 30 daysThe objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.
Description: solicited local and systemic AEs after vaccination
Measure: Incidence of solicited adverse events Time: Through 1 year post vaccinationDescription: unsolicited AEs after vaccination
Measure: Incidence of unsolicited adverse events Time: Through 1 year post vaccinationDescription: percentage of subjects with SAEs
Measure: Incidence of serious adverse events Time: Through 1 year post vaccinationDescription: Change from baseline in antigen-specific binding antibody titers
Measure: Geometric mean titer (GMT) of antigen-specific binding antibody titers Time: Through 1 year post vaccinationDescription: Seroconversion rate can be calculated based on test results reaching the quantifiable antibody level after vaccination
Measure: Percentage of subjects who seroconverted after vaccination Time: Through 1 year post vaccinationDescription: NAb is regarded as produced when FRNT50 is detected more than four times the baseline after vaccination
Measure: Geometric mean titer (GMT) of neutralizing antibody level Time: Through 1 year post vaccinationDescription: Change from baseline in antigen-specific binding antibody titers
Measure: Geometric mean fold rise (GMFR) of antigen-specific binding antibody titers Time: Through 1 year post vaccinationDescription: Antigen-specific IFN-γ T cell immune response assessed before/after vaccination
Measure: Change from baseline in antigen-specific IFN-g cellular immune response Time: Through 1 year post vaccinationThis is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.
Description: Incidence of Adverse Events 1 week post immunisation
Measure: Incidence of Adverse Events Time: 1 weeks post immunisationDescription: COVID19 neutralizing antibody titers post immunisation
Measure: COVID19 neutralizing antibody titers Time: 2 weeks post second immunisationDescription: Frequency of COVID19 spike specific T cells 3 weeks post second immunisation
Measure: COVID19 T cell immunogenicity Time: 3 weeks post second immunisationDescription: COVID19 spike specific antibody titers 6 months post second immunisation
Measure: Durability of antibody response Time: 6 months post immunisation