Covid 19 Research using Clinical Trials (Home Page)
Report for D012818: Signs and Symptoms, Respiratory NIH
(Synonyms: Signs and Symptoms, Respiratory)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug168 | Anakinra plus oSOC Wiki | 0.50 |
| drug2327 | Standard of care (SOC) Wiki | 0.50 |
| drug2646 | Vielight RX Plus Wiki | 0.50 |
| drug2826 | gammaCore® (Vagus nerve stimulation) Wiki | 0.50 |
| drug2827 | gammaCore® Sapphire (non-invasive vagus nerve stimulator) Wiki | 0.50 |
| drug2330 | Standard of care therapies Wiki | 0.50 |
| drug2927 | oSOC Wiki | 0.50 |
| drug230 | Association of diltiazem and niclosamide Wiki | 0.50 |
| drug1086 | Hydroxychloroquine Wiki | 0.05 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.05 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 4 clinical trials
Clinical Trials
1 Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial
The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
NCT04364009 COVID-19 Infection ANAKINRA Treatment Optimized Standard of Care (oSOC) Drug: Anakinra plus oSOC Drug: oSOC MeSH:Signs and Symptoms, Respiratory
Primary Outcomes
Description: The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measure: Treatment success Time: After 14 days of treatmentSecondary Outcomes
Description: Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
Measure: Treatment success Time: After 3 days, 10 days and 28 days of treatmentDescription: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;6. Hospitalized, on invasive mechanical ventilation or ECMO;7. Death.
Measure: OMS progression scale (on a 7 point ordinal scale) Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: Overall survival
Measure: Overall survival Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: Time to ICU admission
Measure: Time to ICU admission Time: Up to 28 daysDescription: Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)
Measure: Time to ventilatory support Time: Up to 28 daysDescription: The National Early Warning Score (NEWS) determines the degree of illness of a patient using six physiological findings and one observation. Score from 0 to 20, 0 mean a worse outcome, 20 mean a better outcome
Measure: Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28 Time: After 3 days, 10 days, 14 days and 28 days of treatmentDescription: C-reactive proteine (mg/L)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: ferritin (ng/mL)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: lymphocyte count (G/L)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: fibrinogen (g/l)
Measure: Change in inflammatory parameter Time: From baseline to Day 3, Day 10, Day 14 and Day 28Description: Hospital length of stay
Measure: Hospital length of stay Time: Up to 28 daysDescription: Need for Vasopressors (yes or no)
Measure: ICU parameter Time: Up to 28 daysDescription: Evolution of SpO2/FIO2 ratio (no unit)
Measure: ICU parameter Time: Up to 28 daysDescription: Evolution of PaO2/FiO2 ratio (no unit)
Measure: ICU parameter Time: Up to 28 daysDescription: Occurrence of serious adverse events during the study, including infection (bacterial, parasitic, mycotic and viral infection), septic shock, Ankanira hypersensitivity, hepatic damages (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: Up to 28 daysDescription: The correlation between several of clinical parameters at inclusion (including level of oxygen requirement (saturation), respiratory rate (per min), temperature (°C)…), biological parameters :including, CRP (mg/L), ferritin (µg/L), LDH (UI/L), lymphocyte count (G/L), eosinophil count (G/L), Ddimers (ng/mM), platelet count (G/L), polymorphonuclear count (G/L)...with the primary end point will be explored.
Measure: Predictors of efficacy of Anakinra Time: After 14 days of treatment2 A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)
The purpose of this study is to asses the efficacy of the Gammacore device reducing the need for mechanical ventilation in patients diagnosed of Covid-19
NCT04368156 Covid-19 Device: gammaCore® (Vagus nerve stimulation) MeSH:Signs and Symptoms, Respiratory
Primary Outcomes
Measure: Need for mechanical ventilation Time: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two monthsSecondary Outcomes
Measure: Supplemental oxygen requirements Time: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two monthsMeasure: Mortality Time: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months
Measure: Delay onset of ventilation Time: From randomization to the day of need for mechanical ventilation or hospital discharge, whatever occurs first, assessed up to two months
Measure: Cytokine levels Time: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months
3 A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The active and control groups will be diseased and severity matched. The primary objective is to reduce initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Secondary objectives are to evaluate cytokine trends/prevent cytokine storms, evaluate supplemental oxygen requirements, decrease mortality of CoViD-19 patients and to delay the onset of mechanical ventilation.
NCT04382391 COVID Corona Virus Infection Respiratory Failure Respiratory Distress Syndrome, Adult ARDS, Human SARS (Severe Acute Respiratory Syndrome) Device: gammaCore® Sapphire (non-invasive vagus nerve stimulator) Other: Standard of care therapies MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome Signs and Symptoms, Respiratory
Primary Outcomes
Description: measure the change (in hours) between the control group and treatment group
Measure: change in initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first, assessed up to 3 monthsSecondary Outcomes
Description: measure the changes in the serum/plasma concentrations of TH1 and TH2-type cytokines
Measure: evaluate cytokine trends Time: From the time of initial blood draw until the time of final blood draw, assessed up to date of mechanical ventilation, death, or discharge from hospital, whichever occurs first,assessed up to 3 monthsDescription: compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.
Measure: evaluate supplemental oxygen requirements Time: From the time of randomization, assessed up to time of mechanical ventilation, day of discharge or death, whichever occurs first,assessed up to 3 monthsDescription: measure the change (in hours) to death between control group and treatment group
Measure: decrease mortality of CoViD-19 patients Time: From the time or randomization until the date of death from any cause, assessed up to day of discharge or death,assessed up to 3 monthsDescription: measure the change (in hours) to time of mechanical ventilation between control group and treatment group
Measure: delay onset of ventilation Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first,assessed up to 3 months4 A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms
The objective of this study is to obtain data on the efficacy of the Vielight RX Plus in decreasing time to recovery of symptoms in subjects with COVID-19. The study will be conducted among COVID-19 positive subjects at home in self-isolation via electronic data collection (EDC). There will be no physical contact between the subjects and the Qualified Investigator (QI) or other study staff. This study aims to demonstrate that the Vielight RX Plus is a useful adjunct to standard of care (SOC). We hypothesize that the Vielight RX Plus will accelerate recovery and reduce viral infection severity.
NCT04418505 COVID-19 Device: Vielight RX Plus MeSH:Signs and Symptoms, Respiratory
Primary Outcomes
Measure: Time to recovery Time: 30 daysSecondary Outcomes
Measure: Time to elimination of COVID-19 related symptoms Time: 30 daysMeasure: Mean number of days with mild COVID-19 related symptoms Time: 30 days
Measure: Mean number of days with mild overall respiratory symptoms Time: 30 days
Measure: Time to symptom reduction Time: 30 days
Measure: Time to elimination of symptoms Time: 30 days
Measure: Average number of days with mild respiratory symptoms Time: 30 days
Measure: Oxygen saturation Time: 30 days
Measure: Hospitalization rate Time: 30 days
Measure: Mortality Time: 30 days