Name (Synonyms) | Correlation | |
---|---|---|
drug389 | Hydroxychloroquine and Azithromycin Wiki | 0.32 |
drug566 | Normal Saline Infusion + Maximal intensive care Wiki | 0.32 |
drug387 | Hydroxychloroquine Sulfate and Azithromycin Wiki | 0.32 |
drug143 | CAStem Wiki | 0.32 |
drug91 | BCG Wiki | 0.32 |
drug61 | Ascorbic Acid and Folic Acid Wiki | 0.32 |
drug77 | Aviptadil (VIP) Wiki | 0.32 |
drug81 | Azinc Wiki | 0.32 |
drug323 | Gimsilumab Wiki | 0.32 |
drug951 | eculizumab Wiki | 0.32 |
drug623 | Placebo for Hydroxychloroquine Wiki | 0.32 |
drug709 | Ruxolitinib administration Wiki | 0.32 |
drug682 | Ravulizumab Wiki | 0.32 |
drug622 | Placebo for Azithromycin Wiki | 0.32 |
drug121 | Biological test Wiki | 0.32 |
drug78 | Aviptadil by intravenous infusion + maximal intensive care Wiki | 0.32 |
drug815 | TD-0903 Wiki | 0.32 |
drug474 | Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki | 0.32 |
drug388 | Hydroxychloroquine Sulfate and Folic Acid Wiki | 0.32 |
drug83 | Azithromycin (Azithro) Wiki | 0.32 |
drug114 | Best Supportive Care Wiki | 0.32 |
drug818 | Tacrolimus Wiki | 0.32 |
drug455 | L-ascorbic acid Wiki | 0.22 |
drug82 | Azithromycin Wiki | 0.20 |
drug361 | Hydroxychloroquine (HCQ) Wiki | 0.18 |
drug616 | Placebo Wiki | 0.13 |
drug360 | Hydroxychloroquine Wiki | 0.12 |
drug507 | Methylprednisolone Wiki | 0.11 |
drug627 | Placebo oral tablet Wiki | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
D055371 | Acute Lung Injury NIH | 0.41 |
D014947 | Wounds and Injuries NIH | 0.39 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.38 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.29 |
D013577 | Syndrome NIH | 0.24 |
D004417 | Dyspnea NIH | 0.18 |
D011024 | Pneumonia, Viral NIH | 0.16 |
D011014 | Pneumonia NIH | 0.08 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.02 |
Name (Synonyms) | Correlation |
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There are 10 clinical trials
Novel Corona Virus (COVID-19) is known to cause Acute Lung Injury/Acute Respiratory Distress Syndrome, that results in death of approximately 80% of those who develop ARDS, despite intensive care and mechanical ventilation. Patients with COVID-19 induced Acute Respiratory Distress Syndrome who are admitted for intensive care including endotracheal intubation and mechanical ventilation will be treated with Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
Description: Mortality
Measure: Mortality Time: 5 Days with followup through 30 daysDescription: Index of Respiratory Distress
Measure: PaO2:FiO2 ratio Time: 5 Days with followup through the end of telemetry monitoringDescription: TNF alpha levels as measured in hospital laboratory
Measure: TNF alpha Time: 5 DaysDescription: Multi-system organ failure free days
Measure: Multi-system organ failure free days Time: 5 days with followup through 30 daysA phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.
Description: Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Measure: Adverse reaction (AE) and severe adverse reaction (SAE) Time: Within 28 days after treatmentDescription: Evaluation by chest CT
Measure: Changes of lung imaging examinations Time: Within 28 days after treatmentDescription: Marker for SARS-CoV-2
Measure: Time to SARS-CoV-2 RT-PCR negative Time: Within 28 days after treatmentDescription: The duration of a fever above 37.3 degrees Celsius
Measure: Duration of fever (Celsius) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Changes of blood oxygen (%) Time: Within 28 days after treatmentDescription: Marker for efficacy
Measure: Rate of all-cause mortality within 28 days Time: Within 28 days after treatmentDescription: Counts of lymphocyte in a litre (L) of blood
Measure: Lymphocyte count (*10^9/L) Time: Within 28 days after treatmentDescription: Alanine aminotransferase in unit (U)/litre(L)
Measure: Alanine aminotransferase (U/L) Time: Within 28 days after treatmentDescription: Creatinine in micromole (umol)/litre(L)
Measure: Creatinine (umol/L) Time: Within 28 days after treatmentDescription: Creatine kinase in U/L
Measure: Creatine kinase (U/L) Time: Within 28 days after treatmentDescription: C-reactive in microgram (mg)/litre(L)
Measure: C-reactive protein (mg/L) Time: Within 28 days after treatmentDescription: Procalcitonin in nanogram (ng)/litre(L)
Measure: Procalcitonin (ng/L) Time: Within 28 days after treatmentDescription: Lactate in millimole(mmol)/litre(L)
Measure: Lactate (mmol/L) Time: Within 28 days after treatmentDescription: IL-1beta in picogram(pg)/millilitre(mL)
Measure: IL-1beta (pg/mL) Time: Within 28 days after treatmentDescription: IL-2 in pg/mL
Measure: IL-2 (pg/mL) Time: Within 28 days after treatmentDescription: IL-6 in pg/mL
Measure: IL-6 (pg/mL) Time: Within 28 days after treatmentDescription: IL-8 in pg/mL
Measure: IL-8 (pg/mL) Time: Within 28 days after treatmentThe primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.
Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpm
Measure: Time to reach clinical stability Time: 28 daysDescription: days
Measure: Time to reach an afebrile state for 48 hours. Time: 56 daysDescription: days
Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300 Time: 56 daysDescription: days
Measure: Time to reach FR ≤ 24 rpm for 48 hours Time: 56 daysDescription: days
Measure: Time to normalization of D-dimer (<250 ug / L) Time: 56 daysDescription: days
Measure: Time until PCR normalization (<5mg / L). Time: 56 daysDescription: days
Measure: Time until normalization of ferritin (<400ug / L) Time: 56 daysDescription: viral load
Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR Time: 56 daysDescription: days
Measure: Time until hospital discharge Time: 56 daysDescription: days
Measure: Need for ventilatory support devices Time: 56 daysDescription: days
Measure: Duration that it is necessary to maintain ventilatory support. Time: 56 daysDescription: days
Measure: COVID-19 mortality Time: 56 daysDescription: days
Measure: all-cause mortality Time: 56 daysDescription: cytokines quantification technique by Luminex
Measure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission Time: 56 daysDescription: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance
Measure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone. Time: 56 daysThis study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.
Description: Documented days free off mechanical ventilation the first 28 days post enrollment
Measure: Number of ventilator-free days Time: Up to 28 daysDescription: Mortality at 28-days by all causes
Measure: All-cause-mortality Time: Up to 28 daysDescription: Number of days free of acute inflammation (defined as CRP >= 10 mg/L)
Measure: Acute-inflammation-free days Time: Up to 28 daysDescription: Number of days that the participant is free of organ failure in ALL of the following organ systems: Cardiovascular, Respiratory, Neurological, Liver, Bone marrow organ, Renal
Measure: Organ-failure-free days Time: Up to 1 yearThis is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
Description: Number and severity of treatment emergent adverse events
Measure: Safety and Tolerability of SAD of TD-0903: Adverse Events Time: Day 1 to Day 8Description: Number and severity of treatment emergent adverse events
Measure: Safety and Tolerability of MAD of TD-0903: Adverse Events Time: Day 1 to Day 14Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC Time: Day 1 through Day 4Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax Time: Day 1 through Day 4Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax Time: Day 1 through Day 4Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC Time: Day 1 through Day 9Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax Time: Day 1 through Day 9Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax Time: Day 1 through Day 9Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.
Description: Vital status at Day 43
Measure: Primary endpoint Time: 43 daysDescription: Incidence and duration of mechanical ventilation use during the study
Measure: Secondary endpoint Time: Day 43Description: Number of days in the ICU
Measure: Secondary endpoint Time: Day 43Description: Number of days of inpatient hospitalization
Measure: Secondary endpoint Time: Day 43This protocol provides access to eculizumab treatment for participants with severe COVID-19.
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.
Description: To determine the efficacy of ruxolitinib measured by overall survival
Measure: Overall survival Time: 28 days after registration into trialDescription: Assessment of the duration of ventilation support
Measure: Assessment of the duration of ventilation support Time: registration unitl 90 days after registration into trialDescription: Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)
Measure: cytokine storm Time: registration unitl 90 days after registration into trialDescription: To assess time on ICU
Measure: time on ICU Time: registration unitl 90 days after registration into trialDescription: To assess toxicity and safety of ruxolitinib treatment
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: registration unitl 90 days after registration into trialDescription: To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)
Measure: time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG) Time: registration unitl 90 days after registration into trialDescription: To assess pulmonary function (time point discharge from hospital) by CT scan
Measure: pulmonary function assessed by a CT scan Time: registration unitl 90 days after registration into trialDescription: To determine the efficacy of ruxolitinib measured by overall survival
Measure: overall survival Time: 90 days after registration into trialBrief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Acute Respiratory Distress Syndrome and the need for mechanical ventilation. Mortality rates as high as 80% have been reported among those who develop ARDS, despite intensive care and mechanical ventilation. Patients with COVID-19 induced non-Acute Lung Injury who have demonstrated reduction in blood oxygenation, dyspnea, and exercise intolerance but do not require endotracheal intubation and mechanical ventilation will be treated with Aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP) plus Standard of Care vs. placebo + Standard of Care. Patients will be randomized to intravenous Aviptadil will receive inhaled Aviptadil, 100 μg 3x daily vs. placebo 3x daily. The primary outcome will be progression to ARDS over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.
Description: Progression to ARDS is defined as the need for mechanical ventilation
Measure: Progression to ARDS Time: 28 daysDescription: Blood PO2 as measured by pulse oximetry
Measure: Blood oxygenation Time: 28 daysDescription: 0 = no shortness of breath at all 0.5 = very, very slight shortness of breath = very mild shortness of breath = mild shortness of breath = moderate shortness of breath or breathing difficulty = somewhat severe shortness of breath = strong or hard breathing 7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity
Measure: RDP Dsypnea Scale Time: 28 daysDescription: Distance walked in six minutes
Measure: Distance walked in six minutes Time: 28 daysThis study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.