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Name (Synonyms) | Correlation | |
---|---|---|
drug3349 | TD-0903 Wiki | 0.27 |
drug2800 | Ramelteon 8mg Wiki | 0.19 |
drug358 | Awake prone positioning Wiki | 0.19 |
Name (Synonyms) | Correlation | |
---|---|---|
drug1854 | Lopinavir / Ritonavir Pill Wiki | 0.19 |
drug1785 | Knowledge, Attitude, Practice, Awareness, Preference Wiki | 0.19 |
drug1906 | Lung CT scan analysis in COVID-19 patients Wiki | 0.19 |
drug3362 | TRIIM Treatment Wiki | 0.19 |
drug3161 | Sodium Nitrite Wiki | 0.19 |
drug3617 | VIB7734 Wiki | 0.19 |
drug2473 | Personal freedom message Wiki | 0.19 |
drug3540 | Trust in science message Wiki | 0.19 |
drug854 | Community interest message Wiki | 0.19 |
drug242 | Anger message Wiki | 0.19 |
drug140 | AZD8154 nebuliser Wiki | 0.19 |
drug2934 | Ruxolitinib administration Wiki | 0.19 |
drug890 | Control message Wiki | 0.19 |
drug2547 | Placebo injection Wiki | 0.19 |
drug153 | Acacia Senegal Wiki | 0.19 |
drug593 | CERC-002 Wiki | 0.19 |
drug128 | AVIGAN 200 mg FT Wiki | 0.19 |
drug1905 | Lung CT Wiki | 0.19 |
drug1080 | Dociparastat sodium Wiki | 0.19 |
drug222 | Ambrisentan Wiki | 0.19 |
drug1904 | Lucinactant Wiki | 0.19 |
drug273 | Anticoagulation Agents (Edoxaban and/or high dose LMWH) Wiki | 0.19 |
drug2488 | Phsyiotherapy Wiki | 0.19 |
drug1151 | Economic benefit message Wiki | 0.19 |
drug2806 | Rapamycin Wiki | 0.19 |
drug167 | Active COVID-19 disease Wiki | 0.19 |
drug1109 | During COVID-19 Pandemic Wiki | 0.19 |
drug2265 | Not bravery message Wiki | 0.19 |
drug277 | Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 Wiki | 0.19 |
drug584 | CAStem Wiki | 0.19 |
drug2704 | Pulmonary and Motor Rehabilitation Wiki | 0.19 |
drug1152 | Economic freedom message Wiki | 0.19 |
drug250 | Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki | 0.19 |
drug3367 | Tacrolimus Wiki | 0.19 |
drug195 | After COVID-19 Pandemic Wiki | 0.19 |
drug355 | Aviptadil by intravenous infusion + standard of care Wiki | 0.19 |
drug1401 | Gimsilumab Wiki | 0.19 |
drug2822 | Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid Wiki | 0.19 |
drug448 | Baseline message Wiki | 0.19 |
drug1177 | Embarrassment message Wiki | 0.19 |
drug170 | Active Control Wiki | 0.19 |
drug182 | AdimrSC-2f Wiki | 0.19 |
drug1273 | FAVIR 200 MG FT Wiki | 0.19 |
drug3870 | eculizumab Wiki | 0.19 |
drug3241 | Standard oxygen therapy Wiki | 0.19 |
drug138 | AZD8154 Monodose DPI presented in capsules Wiki | 0.19 |
drug2449 | Pectin Wiki | 0.19 |
drug269 | Antibody testing Wiki | 0.19 |
drug2170 | Nebulized administration of RLF-100 or Placebo Wiki | 0.19 |
drug2253 | Normal Saline Infusion + standard of care Wiki | 0.19 |
drug139 | AZD8154 Placebo Monodose DPI presented in capsules Wiki | 0.19 |
drug1429 | Guilt message Wiki | 0.19 |
drug2166 | Nebulised heparin Wiki | 0.19 |
drug3073 | Self-interest message Wiki | 0.19 |
drug989 | Dapagliflozin Wiki | 0.19 |
drug8 | 0.9% Sodium-chloride Wiki | 0.19 |
drug1889 | Low dose Low molecular weight heparin or Placebo Wiki | 0.19 |
drug290 | Apramycin injection Wiki | 0.19 |
drug2776 | RLF-100 (aviptadil) Wiki | 0.14 |
drug1787 | L-ascorbic acid Wiki | 0.14 |
drug360 | Ayurveda Wiki | 0.14 |
drug2812 | Ravulizumab Wiki | 0.14 |
drug1609 | Ibrutinib Wiki | 0.14 |
drug1121 | EDP1815 Wiki | 0.14 |
drug467 | Best Supportive Care Wiki | 0.11 |
drug1465 | Heparin Wiki | 0.11 |
drug2505 | Placebo Wiki | 0.10 |
drug176 | Ad26.COV2.S Wiki | 0.10 |
drug304 | Ascorbic Acid Wiki | 0.10 |
drug2251 | Normal Saline Wiki | 0.09 |
drug3257 | Standard treatment Wiki | 0.08 |
drug364 | Azithromycin Wiki | 0.06 |
drug2037 | Methylprednisolone Wiki | 0.05 |
drug2572 | Placebos Wiki | 0.05 |
drug3231 | Standard of care Wiki | 0.04 |
drug1520 | Hydroxychloroquine Wiki | 0.02 |
Name (Synonyms) | Correlation | |
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D055371 | Acute Lung Injury NIH | 0.34 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.32 |
D014947 | Wounds and Injuries NIH | 0.21 |
Name (Synonyms) | Correlation | |
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D063806 | Myalgia NIH | 0.19 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.19 |
D004417 | Dyspnea NIH | 0.13 |
D013577 | Syndrome NIH | 0.07 |
D011024 | Pneumonia, Viral NIH | 0.07 |
D011014 | Pneumonia NIH | 0.05 |
D007251 | Influenza, Human NIH | 0.05 |
D007249 | Inflammation NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D016638 | Critical Illness NIH | 0.02 |
D014777 | Virus Diseases NIH | 0.02 |
D007239 | Infection NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0003326 | Myalgia HPO | 0.19 |
HP:0002098 | Respiratory distress HPO | 0.14 |
HP:0002090 | Pneumonia HPO | 0.05 |
Navigate: Correlations HPO
There are 27 clinical trials
Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or 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 daysDescription: Days free of Respiratory Failure
Measure: Days free of Respiratory Failure Time: 14 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: Subjects who die will be assigned "0" ventilator-free days
Measure: Number of ventilator-free days Time: Baseline to Day 29This 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 until 90 days after registration into trialDescription: Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)
Measure: cytokine storm Time: registration until 90 days after registration into trialDescription: To assess time on ICU
Measure: time on ICU Time: registration until 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 until 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 until 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 until 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 Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) 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.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.
Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Alive and Without Respiratory Failure Time: Day 28Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).
Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline Time: Day 14Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.
Measure: Median Reduction in Days Spent on Supplemental Oxygen Time: Up to Day 28Description: Percentage of participants with mortality from any cause.
Measure: All-Cause Mortality Time: Up to Day 28Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Experiencing Respiratory Failure or Death Time: Up to Day 28Description: Percentage of participants alive and not requiring mechanical ventilation.
Measure: Mechanical Ventilation-Free Survival Time: Up to Day 56Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.
Measure: Days on Mechanical Ventilation Time: Up to Day 56Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.
Measure: Duration of hospitalization Time: Up to Day 56Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.
Measure: Time to Discharge Time: Up to Day 56Description: PaO2:FiO2 ratio is an index of respiratory distress.
Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio Time: Up to Day 56Description: Oxygenation Index is a parameter of pulmonary function of participants.
Measure: Oxygenation Index Time: Up to Day 56Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measure: Number of Participants With Adverse Events Time: Up to Day 56Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measure: Number of Participants With Abnormal Laboratory Findings Time: Up to Day 56COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Description: days of ICU stay
Measure: Length of ICU stay Time: up to 60 daysDescription: days of hospital stay
Measure: Length of hospital stay Time: up to 90 daysCombination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ ________________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. A study demonstrated that the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure. pretreatment of B38-CAP markedly down regulated a massive increase of plasma Ang II levels at 5 min after Ang II injection In addition to the currently used drugs to inhibit Ang II generation or signaling, such as ACE inhibitors or Angiotensin receptor blockers, direct down-modulation of Ang II levels by rhACE2 protein is one of the promising candidates for new therapeutic strategy in cardiovascular disease and other Ang II-related diseases, e.g. ARDS. On the other hand, although mass production of rhACE2 as a protein drug costs due to requirement of mammalian cell expression systems, B38-CAP is easily prepared with E. coli expression system and is cost effective. Therapeutic efficacy and less toxicity in mouse heart failure models would warrant further investigation of B38-CAP or other microbial carboxypeptidases in disease models. Finally the principal investigator expects that treatment with ACE2-like enzyme of bacteria B38-CAP expected to work efficiently Like human ACE2 and it will save the lung cells from COVID - 19 inhibitory effect and down regulation of ACE2 because COVID-19 binds to human ACE2 and down regulates it and this receptors is very important for lung cells survival and function So ,the principal investigator also expects that B38-CAP ACE2 like enzyme may be not recognized by COVID -19 spike protein because evolutionary it is too far away from human ace2 and human ACE2 is a real receptor of COVID -19 not ACE2 like enzyme but in the same time it will make the same function of human ACE2 In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening . So, the principal investigator expects strong inhibition of COVID - 19 infection And rescuing the lung cells from its serious attack by treating with ACE2 like enzyme and Isotretinoin Keywords: COVID 2019 , Isotretinoin,B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
Description: Compare the time course of body temperature (fever) between two groups over time.
Measure: Time course of body temperature (fever) Time: at 14 daysDescription: Compare viral load between two groups over time.
Measure: Viral load over time Time: 14 daysDescription: PaO2/FiO2 ratio
Measure: P/F ratio over time Time: 14 daysDescription: SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Measure: Sequential organ failure assessment score(SOFA score) over time Time: 14 daysDescription: Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Measure: Image examination of chest over time Time: 14 daysThis is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.
Description: The AUC for OI through 12 hours measured using the trapezoidal method, where OI is defined as mean airway pressure (Paw)×fraction of inspired oxygen (FiO2)×100/arterial pressure of oxygen (PaO2)
Measure: Oxygenation index (OI) area under the curve (AUC)0-12 Time: 12 hours post initiation of dosingDescription: FiO2 change from baseline
Measure: FiO2 Time: 24 hours post initiation of dosingDescription: PaO2 change from baseline
Measure: PaO2 Time: 24 hours post initiation of dosingDescription: SpO2 change from baseline
Measure: Oxygenation from pulse oximetry (SpO2) Time: 24 hours post initiation of dosingDescription: Change from baseline in P/F ratio, defined as PaO2/FiO2
Measure: P/F ratio Time: 24 hours post initiation of dosingDescription: Change from baseline in VI, defined as [respiration rate (RR)×(peak inspriatory pressure [PIP] - peak expiratory end pressure [PEEP])× arterial pressure of carbon dioxide (PaCO2)]/1000
Measure: Ventilation Index (VI) Time: 24 hours post initiation of dosingDescription: Change from baseline in lung compliance, as measured by the ventilator
Measure: Lung compliance Time: 24 hours post initiation of dosingA randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.
Description: Alive and free of invasive mechanical ventilation
Measure: Proportion of participants who are alive and free of invasive mechanical ventilation Time: Through Day 28Description: Time to all-cause mortality
Measure: All-cause mortality Time: Through Day 28This is a multicenter observational retrospective cohort study that aims to study the morphological characteristics of the lung parenchyma of SARS-CoV2 positive patients identifiable in patterns through artificial intelligence techniques and their impact on patient outcome.
Description: Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT through artificial intelligence techniques.
Measure: A qualitative analysis of parenchymal lung damage induced by COVID-19 Time: Until patient discharge from the hospital (approximately 6 months)Description: Describe the parenchymal lung damage induced by COVID-19 through a quantitative analysis with chest CT through artificial intelligence techniques.
Measure: A quantitative analysis of parenchymal lung damage induced by COVID-19 Time: Until patient discharge from the hospital (approximately 6 months)Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as intensive care mortality.
Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure. Time: Until patient discharge from the hospital (approximately 6 months)Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as hospital mortality.
Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure. Time: Until patient discharge from the hospital (approximately 6 months)Description: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure assessed as days free from mechanical ventilation.
Measure: The potential impact of parenchymal morphological CT scans in patients with severe moderate respiratory failure. Time: Until patient discharge from the hospital (approximately 6 months)Description: The hypothesis is that the uso of deep neural network models for lung segmentation in Acute Respiratory Distress Syndrome (ARDS) in animal models and Chronic Obstructive Pulmonary Disease (COPD) in patients that could be applied to self-segment the lungs of COVID-19 patients through a learning transfer mechanism with artificial intelligence.
Measure: Automated segmentation of lung scans of patients with COVID-19 and ARDS. Time: Until patient discharge from the hospital (approximately 6 months)Description: Expand the knowledge of chest CT features in COVID-19 patients and their detail through the use of machine learning and other quantitative techniques comparing CT patterns of COVID-19 patients to those of patients with ARDS.
Measure: Knowledge of chest CT features in COVID-19 patients and their detail through the use of machine learning and other quantitative techniques. Time: Until patient discharge from the hospital (approximately 6 months)Description: Determine the capacity within which the artificial intelligence analysis that uses deep learning models can be used to predict clinical outcomes from the analysis of the characteristics of the chest CT obtained within 7 days of hospital admission; combining quantitative CT data with clinical data.
Measure: The ability within which the analysis of artificial intelligence that uses deep learning models can be used to predict clinical outcomes Time: Until patient discharge from the hospital (approximately 6 months)Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury and require mechanical ventilation.
Description: Proportion of study subjects who are alive and free of respiratory failure at Day 28
Measure: Survival with Unassisted Breathing Time: Day 28Description: Number of days alive without mechanical ventilation from start of study through Day 28
Measure: Survival without Mechanical Ventilation Time: Day 28Description: Number of days alive and not in the intensive care unit from start of study through Day 28.
Measure: Survival without Intensive Care Time: Day 28Description: Number of days alive and not in hospital from start of study through Day 28.
Measure: Survival without Hospitalization Time: Day 28Description: Alive on Day 28 and no use of ECMO therapy any time between start of study and Day 28.
Measure: Survival without ECMO Time: Day 28Description: Alive on Day 28
Measure: Survival Time: Day 28Description: Oxygenation index (PaO2/FIO2) at Day 14
Measure: Lung Status Time: Day 14Description: Blood urea nitrogen (BUN) at Day 14
Measure: Kidney Status (1) Time: Day 14Description: Creatinine at Day 14
Measure: Kidney Status (2) Time: Day 14Description: Liver function tests (ALT and AST) at Day 14
Measure: Liver Status Time: Day 14This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.
Description: Change from baseline in SaO2/FiO2 ratio
Measure: Part 2: SaO2/FiO2 ratio Time: Baseline, Day 7Description: Number of days the subject was not using invasive mechanical ventilation or non-invasive positive pressure ventilation
Measure: Part 2: Ventilator-free Days (VFDs) Time: Baseline through Day 28Description: Number of days the subject was not in the ICU
Measure: Part 2: Intensive Care Unit Free Days (ICU-free) Time: Baseline through Day 28Description: Area under the plasma concentration-time curve (AUC) in SaO2/FiO2 ratio
Measure: Part 2: AUC in SaO2/FiO2 ratio Time: Baseline through Day 7Description: Change from baseline in SaO2/FiO2 ratio
Measure: Part 2: SaO2/FiO2 ratio Time: Baseline, Day 5Description: Proportion of subjects with a SaO2/FiO2 ratio > 315
Measure: Part 2: SaO2/FiO2 ratio > 315 Time: Day 5, Day 7Description: Proportion of subjects discharged
Measure: Part 2: Subjects Discharged Time: Day 7, 14, 21 and 28Description: Time to hospital discharge
Measure: Part 2: Hospital Discharge Time: Baseline through up to Day 28Description: The subject mortality rate (all causes)
Measure: Part 2: Mortality Rate Time: Day 28Description: Change from baseline in the modified Borg Dyspnea Score. The modified Borg Dyspnea Score is based on a 10-point scale that measures shortness of breath. Scores range from 0 (nothing at all, no shortness of breath) to 10 (maximal shortness of breath).
Measure: Part 2: Modified Borg Dyspnea Score Time: Baseline through Day 7Description: Proportion of subjects in each category of the Clinical Status scale. The Clinical Status scale contains 6 different categories that are each assigned a numeric score. The values range from 1 (representing 'Not hospitalized'), 2 (hospitalized, not requiring supplemental oxygen), 3 (hospitalized, requiring low-flow oxygen supplementation), 4 (hospitalized, on non-invasive positive pressure ventilation or high-flow oxygen supplementation), 5 (hospitalized, on invasive mechanical ventilation, 6 (Death).
Measure: Part 2: Clinical Status Scale Time: Day 7, 14, 21 and 28Description: Proportion of subjects in each category of Vital Status, where the categories are defined as death, discharge, or hospitalized.
Measure: Part 2: Vital Status Time: Day 7, 14, 21 and 28Description: Proportion of subjects alive and free of ventilatory support
Measure: Part 2: Subjects alive and free of ventilatory support Time: Day 28The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT, for the treatment of patients with COVID-19 pneumonia who have mild to moderate ARDS. LIGHT is a cytokine in the TNF super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.
Description: Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation, Extracorporeal membrane oxygenation
Measure: Proportion of patient alive and free of respiratory failure Time: Baseline to Day 28Description: 1-month mortality
Measure: Proportion of subjects who are alive Time: Baseline to Day 28Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.
Description: KAP towards COVID-19 was assessed using validated questionnnaire
Measure: Knowledge, Attitude, Practice of dental students towards COVID-19 Time: 4 monthsDescription: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire
Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics Time: 4 monthsDescription: Preference towards online learning. was assessed using a standard questionnaire
Measure: Preference towards online learning. Time: 4 monthsCOVID-19 is impacting on health systems in Brazil and worldwide. Reducing the risk of clinical deterioration and prolonged disease duration in hospitalized patients with COVID-19 may alleviate the burden caused by the pandemic. Melatonin (N-acetyl-5-methoxytryptamine) has demonstrated antiapoptotic, antioxidative, and anti-inflammatory roles and has been suggested as a potential protector against organ injuries and even mediate lower mortality rates after polymicrobial sepsis in animal models. Melatonin agonists may modulate protective effects against acute lung injury and play a clinical role in individuals with SARS-CoV-2 infection. The investigators proposed a clinical trial testing the effects of ramelteon 8mg in hospitalized patients with COVID-19.
Description: Defined as a National Early Warning Score 2 (NEWS2) of 0 maintained for 24 hours [Time Frame: Assessed daily (enrollment is day 0)] The NEWS consists of a simple aggregate scoring system based on physiological measurements, regularly registered in inpatient settings, including six parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and temperature.
Measure: Time to resolution of symptoms [National Early Warning Score 2 (NEWS2) of 0] Time: enrollment is day 0Description: Critical COVID-19 illness as a composite of admission to the intensive care unit (ICU), invasive ventilation, or death
Measure: Clinical worsening to critical COVID-19 illness Time: until Day 30Description: Measured by duration of use of supplemental oxygen (if applicable)
Measure: Duration of supplemental oxygen therapy Time: until day 14Description: Measured by duration of use of mechanical ventilation
Measure: Duration of mechanical ventilation (if applicable) Time: until day 30Description: Measured by duration of hospitalization
Measure: Duration of hospitalisation Time: until day 30Description: Presence or absence of SARS-CoV-2 Viral RNA in nasopharyngeal swab or lower respiratory secretions
Measure: Proportion of participants with virologic clearance in nasopharyngeal swab RT-PCR Time: Day 14Description: Reduction of C-reactive protein levels > 50% in comparison with PCR levels at the admission
Measure: C-reactive protein (CRP) level's reduction Time: Days 3, 5 and 8Description: Incidence of new onset lymphopenia during hospitalization measured by blood draw
Measure: Incidence of New Onset Lymphopenia Time: Through study completion, average of 15 daysDescription: Reduction of mean direct bilirubin levels in comparison with levels at the admission
Measure: Direct bilirubin level's reduction Time: Measured in study Days 3, 5, and 8Description: Differences in number of patients in study arms who experienced side effects
Measure: Side Effects Time: until day 14This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.
Description: The proportion of participants who survive without respiratory failure
Measure: Survival rate Time: 4 weeksDescription: The WHO ordinal scale is a measure of clinical improvement using a scale score of 0-8, where 0 indicates a better outcome and 8 indicates death: Uninfected, no clinical oor virological evidence of infection 0 Ambulatory, no limitation of activities 1 Ambulatory, limitation of activities 2 Hospitalized Mild disease, no oxygen therapy 3 Hospitalized mild disease, oxygen by mask or nasal prongs 4 Hospitalized Severe Disease, non-invasive ventilation 5 Hospitalized severe disease, intubation and mechanical ventilation 6 Hospitalized severe disease, ventilation+organ support 7 Death 8
Measure: Change in Clinical Status assessed by the World Health Organization (WHO) scale Time: Baseline to 4 weeksDescription: An ordinal scale for clinical improvement scored from 1 to 8, where 1 represents death and 8 represents recovery to discharge from hospital with no limitation on activities: Death (1) Hospitalized, on invasive mechanical ventilation of extracorporeal membrane oxygenation (ECMO) (2) Hospitalized, on non-invasive ventilation or high flow oxygen devices (3) Hospitalized, requiring supplemental oxygen (4) Hospitalized, not requiring supplemental oxygen or ongoing medical care (6) Not hospitalized, limitation on activities &/or requiring supplemental home oxygen (7) Not hospitalized, no limitation on activities (8)
Measure: Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale Time: Baseline to 4 weeksDescription: Total number of deaths during the study period
Measure: All cause mortality Time: 4 weeksDescription: Number of days on ECMO
Measure: Duration of ECMO Time: Up to 4 weeksDescription: Number of days participants are on supplemental oxygen
Measure: Duration of supplemental oxygen Time: Up to 4 weeksDescription: Days of hospitalization
Measure: Length of hospital stay Time: Up to 4 weeksDescription: Number of days until there is a negative response to the reverse transcriptase-polymerase chain reaction test (RT-PCR)
Measure: Length of time to SARS-CoV2 negativity Time: Up to 4 weeksThe investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to evaluate the association between the radiological CT pattern and the need for invasive mechanical ventilation. A secondary aim is to assess the mortality within the first 28 days of intensive care unit admission.
Description: Need for oral intubation within the first 10 days.
Measure: Oral intubation Time: 10 daysDescription: 28-day survival analysis using the Kaplan Meyer and Cox regression models.
Measure: Survival Time: 28 daysAcute Respiratory Distress Syndrome (ARDS) reflects the hallmark of the critical course of COVID19. We have recently shown that Exhaled Breath Particles (EBP) measured as particle flowrate (PFR) from the airways could be used as a noninvasive real time early detection method for primary graft dysfunction (similar to ARDS) in lung transplant patients and for ARDS in a large animal model. PFR increased before the cytokine storm. Early detection of ALI and ARDS is crucial for the patient's chance of survival as early treatment, such as preparing for intensive care, prone position and protective ventilation when the patient is treated in mechanical ventilation, can be implemented early in the process. In the present study we aim to use real time PFR as an early detector for COVID19 induced ARDS. We will also collect EBPs onto a membrane for subsequent molecular analysis. Previous studies have shown that most of those proteins found in broncho alveolar lavage (BAL) are also found in EBP. We therefore also aim to be able to diagnose COVID19 by analyzing EBP using PCR with the same specificity as PCR from BAL, but also to identify protein biomarkers for early detection of ARDS.
Description: Detect COVID-19 in EBP using RT-PCR
Measure: COVID-19 RT-PCR detection in EBP Time: 12-36 monthsDescription: Detection of proteins biomarkers in EBP
Measure: Detection of proteins biomarkers in EBP Time: 12-36 monthsDescription: We have recently shown that Exhaled Breath Particles (EBP) measured as particle flowrate (PFR) from the airways could be used as a noninvasive real time early detection method for primary graft dysfunction (similar to ARDS) in lung transplant patients and for ARDS in a large animal model. PFR increased before the cytokine storm. Early detection of ALI and ARDS is crucial for the patient's chance of survival as early treatment, such as preparing for intensive care, prone position and protective ventilation when the patient is treated in mechanical ventilation, can be implemented early in the process. In the present study we aim to use real time PFR as an early detector for COVID19 induced ARDS.
Measure: Particle flow rate as an early indicator for lung injury Time: 12-36 monthsExisting information suggests that a drug called heparin, given through a device called a nebuliser, will decrease severity of lung damage caused by COVID-19 who require the assistance of a ventilator to breathe. It is thought that heparin could do this through multiple mechanisms. The investigators will measure the effect with a marker called d-dimer, which is related to blood clotting, and monitor the safety of this treatment as one of the major outcomes for the study. The investigators will also assess clinical outcomes such as markers of oxygen levels, time to liberation from a ventilator in patients with COVID-19 lung disease, and functional outcomes at day 28 and 60 as secondary outcomes.
Description: Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.
Measure: D-dimer profile Time: Up to day 10.Description: Safety of nebulised heparin delivered by aerogen solo nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.
Measure: Frequenccy of Severe Adverse Outcomes Time: Up to day 60Description: Determine the impact of nebulised heparin on oxygenation index
Measure: Oxygenation Index Time: Up to day 10Description: Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1β, IL-6, IL-8, IL-10 and soluble TNF receptor 1 (sTNFR1), C-reactive protein, procalcitonin, Ferritin,) will be assessed (AUC on days 1, 3, 5 and 10)
Measure: Indices of Inflammation Time: Up to day 10Description: Effect of nebulised heparin on the ratios of IL-1β/IL-10 and IL-6/IL-10 will also be assessed.
Measure: Ratios of Indices of Inflammation Time: Up to day 10Description: Effect of nebulised heparin on other indices of coagulation (Fibrinogen; lactate dehydrogenase) will be assessed (AUC on days 1, 3, 5 and 10).
Measure: Indices of Coagulation Time: Up to day 10Description: Determine the effect of nebulised heparin on Quasi-Static Lung Compliance (i.e. tidal volume/(Plateau pressure-PEEP) measured on days 1,3,5,10.
Measure: Quasi-Static Lung Compliance Time: Up to day 10Description: Time to separation from invasive ventilation, where non survivors are treated as though not separated from invasive ventilation.
Measure: Time to separation from invasive ventilation Time: Up to day 28Description: Number treated with neuromuscular blockers instituted after enrolment
Measure: Number treated with neuromuscular blockers Time: Up to day 10Description: Number treated with prone positioning instituted after enrolment
Measure: Number treated with Prone positioning Time: Up to day 10Description: Number treated with extra-corporeal membrane oxygenation instituted after enrolment
Measure: Number treated with extra-corporeal membrane oxygenation Time: Up to day 10Description: Number tracheotomised
Measure: Number requiring Tracheostomy Time: Up to day 28Description: Time to separation from invasive ventilation among survivors
Measure: Time to separation from invasive ventilation among survivors Time: Up to day 28Description: Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from invasive care
Measure: Discharge to ward Time: Up to day 28Description: Time to discharge from the ICU to day 28, among survivors
Measure: Discharge to ward in survivors Time: Up to day 28Description: Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60
Measure: Patient Survival Time: Up to day 60Description: Number residing at home or in a community setting at day 60
Measure: Number of patients residing at home or in a community setting at day 60 Time: Up to day 60Description: Number residing at home or in a community setting at day 60, among survivors
Measure: Number of surviving patients residing at home or in a community Time: Up to day 60The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
Description: Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)
Measure: The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness Time: Day 1 (Baseline) through Day 28Description: Defined as measure of safety
Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events Time: Day 1 (Baseline) through Day 70Description: Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time [PT], partial thromboplastin time [PTT], D dimer, fibrinogen), and urinalysis)
Measure: Change in safety laboratory parameters Time: Day 1 (Baseline) through Day 70Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports