Covid 19 Research using Clinical Trials (Home Page)
Usual CareWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1977 | Quercetin Treatment Wiki | 0.45 |
| drug1976 | Quercetin Prophylaxis Wiki | 0.45 |
| drug2957 | poractant alfa Wiki | 0.45 |
| drug1917 | Prone Wiki | 0.45 |
| drug998 | Gimsilumab Wiki | 0.45 |
| drug258 | Ayurveda Wiki | 0.32 |
| drug2256 | Siltuximab Wiki | 0.32 |
| drug1923 | Prone positioning Wiki | 0.26 |
| drug159 | Anakinra Wiki | 0.17 |
| drug601 | Colchicine Wiki | 0.16 |
| drug1484 | Methylprednisolone Wiki | 0.13 |
| drug2527 | Tocilizumab Wiki | 0.08 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055370 | Lung Injury NIH | 0.10 |
| D055371 | Acute Lung Injury NIH | 0.09 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.09 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.08 |
| D013577 | Syndrome NIH | 0.05 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.03 |
There are 5 clinical trials
Clinical Trials
1 SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
In community acquired pneumonia, corticosteroids have been shown to have potential benefit. However, the limited and variable use of adjunctive corticosteroids in critically ill patients is largely due to an inability to identify patients that will benefit from the use of anti-inflammatory medications. This study compares usual care to a novel biomarker-tailored steroid dosing algorithm for patients with community acquired pneumonia. In April 2020, in response to the SARS CoV-2 pandemic, we added a COVID-19 arm to this study. The study will evaluate the role of biomarker-titrated adjuvant corticosteroid administration compared to usual care in patients admitted to hospital with SARS CoV-2 (COVID-19) infection and acute respiratory failure.
NCT03852537 Pneumonia Drug: Methylprednisolone Other: Usual Care MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation Time: Within 30 days of enrollment in study.
Secondary Outcomes
Description: Death from any cause
Measure: Mortality Time: Within 30 days and 90 days of study enrollment
Description: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.
Measure: Progression of disease Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)
Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio
Measure: Evolution of respiratory failure Time: Within 72 hours of enrollment in study.
Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).
Measure: Evolution of kidney failure Time: Within 72 hours of enrollment in study.
Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).
Measure: Evolution of shock Time: Within 72 hours of enrollment in study.
Description: In hospital and in ICU
Measure: Length of stay Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.
Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia Time: Up to day +5 following study enrollment.
Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium Time: Up to day +5 following study enrollment.
Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection Time: Up to day +14 following study enrollment.
2 A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome
Primary Outcomes
Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation Time: Within 30 days of enrollment in study.Secondary Outcomes
Description: Death from any cause
Measure: Mortality Time: Within 30 days and 90 days of study enrollmentDescription: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.
Measure: Progression of disease Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio
Measure: Evolution of respiratory failure Time: Within 72 hours of enrollment in study.Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).
Measure: Evolution of kidney failure Time: Within 72 hours of enrollment in study.Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).
Measure: Evolution of shock Time: Within 72 hours of enrollment in study.Description: In hospital and in ICU
Measure: Length of stay Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia Time: Up to day +5 following study enrollment.Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium Time: Up to day +5 following study enrollment.Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection Time: Up to day +14 following study enrollment.The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
NCT04330638 COVID-19 Other: Usual Care Drug: Anakinra Drug: Siltuximab Drug: Tocilizumab
Primary Outcomes
Description: defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the hospital: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Time to Clinical Improvement Time: at day 15Secondary Outcomes
Description: defined as independece from supplemental oxygen
Measure: Time to improvement in oxygenation Time: during hospital admission (up to 28 days)Description: defined by Pa02/FiO2 ratio while breading room air
Measure: Mean change in oxygenation Time: day 1, day 15 or hospital discharge, whichever is firstMeasure: Number of days with hypoxia Time: during hospital admission (up to 28 days)
Measure: Number of days of supplemental oxygen use Time: during hospital admission (up to 28 days)
Measure: Time to absence fever for more than 48h without antipyretics Time: during hospital admission (up to 28 days)
Measure: Number of days with fever Time: during hospital admission (up to 28 days)
Measure: Time to halving of CRP levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Time to halving of ferritin levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Incidence of AEs (Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Incidence of SAEs (Serious Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay in survivors Time: during hospital admission (up to 28 days)
Description: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7 Time: Day 1, day 7or hospital discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1 Time: at day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6 Time: at day 15 or hospital discharge, whichever is firstMeasure: Incidence of nosocomial bacterial or invasive fungal infection Time: during hospital admission (up to 28 days)
Description: defined by Hs (Hemophagocytic Syndrome) score
Measure: incidence of secondary haemophagocytic lymphohistiocytosis Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1 Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6 Time: during hospital admission (up to 28 days)Measure: Time to first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time to first use of salvage systemic steroids in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Number of ventilator free days Time: during hospital admission (up to 28 days)
Measure: Duration of mechanical ventilation in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients, according to the adapted Berlin criteria Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-1 Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-6 Time: during hospital admission (up to 28 days)
Measure: All-cause mortality rate (excluding group that entered during ventilation) Time: during hospital admission (up to 28 days)
Measure: Percentage of patients in clinical status on 6-point Ordinal Scale Time: at 10-20 weeks follow-up
Measure: Incidence of lung function abnormalities Time: at 10-20 weeks follow-up
Measure: Incidence of lung fibrosis on chest CT scan Time: at 10-20 weeks follow-up
Measure: All-cause mortality rate Time: at 10-20 weeks follow-up
3 Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial
This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.
NCT04351542 Flu Like Illness Dietary Supplement: Ayurveda Other: Usual Care
Primary Outcomes
Description: Time to bring down a fever (oral temperature < 37.2 ̊C)
Measure: Time to achieve afebrile Time: Change from baseline to 3rd and 7th-dayDescription: Symptoms diary card completed twice daily from Day 0 to Day 7
Measure: Severity of symptom score Time: Change from baseline to 3rd and 7th daySecondary Outcomes
Description: Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong
Measure: Patient reported improvement Time: Change from baseline to 3rd and 7th-day4 Pragmatic Trial Exploring Impact of Patient Positioning in the Management of Patients Infected With COVID-19: Supine vs. Prone
This study aims to determine if provider-recommended guidance on supine (on back) vs. prone (on stomach) positioning of patients testing positive for COVID-19 requiring supplemental oxygen, but not yet mechanically ventilated, improves outcomes in the inpatient setting. This study will be performed as a pragmatic clinical trial.
NCT04359797 COVID-19 Other: Prone Other: Usual Care
Primary Outcomes
Description: The highest level of support on the 5th day after enrollment according to the following scale adjusted for patient status at enrollment according to the same scale and ranked by mean FIO2 within each category, as appropriate. Death ECMO Mechanical ventilation (ranked by mean FIO2) Non-invasive ventilation such as BiPAP (ranked by mean FIO2) High flow nasal cannula, e.g. Optiflow, Vapotherm or other similar device (titrated by FiO2%) (ranked by mean FIO2) Standard nasal cannula (titrated by L/min up to 15 L/min) or face mask (ranked by mean FIO2) Room air
Measure: Modified WHO Ordinal Scale Time: 5 days post-randomizationSecondary Outcomes
Description: For each day, the investigators will record the most intensive oxygen delivery mode and then, for that highest level of oxygen support device, the max FiO2 while exposed to that device.
Measure: FIO2 Time: First 5 days post-randomization5 COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)
The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.
NCT04363437 Coronavirus Infection Drug: Colchicine Drug: Usual Care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Measure: Percentage of Patients requiring supplemental oxygen beyond 8L nasal cannula Time: through study completion, estimated 2 monthsSecondary Outcomes
Measure: Percentage of patients who will require mechanical ventillation Time: through study completion, estimated 2 monthsMeasure: Hospital length of stay Time: through study completion, estimated 2 months
Measure: Mortality Time: through study completion, estimated 2 months
Measure: Maximum CRP Time: through study completion, estimated 2 months
Measure: Maximum troponin elevation Time: through study completion, estimated 2 months