CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D000075902: Clinical Deterioration NIH

(Synonyms: Clinical Deterioration)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug2018 PB1046 Wiki 0.71
drug3236 convalescent plasma application to SARS-CoV-2 infected patients Wiki 0.71
drug1609 Low Dose (10 mg) Control Wiki 0.71
drug916 Dornase Alfa Inhalation Solution Wiki 0.71
drug313 Azithromycin Wiki 0.12
drug1284 Hydroxychloroquine Wiki 0.07

Correlated MeSH Terms (12)


Name (Synonyms) Correlation
D011654 Pulmonary Edema NIH 0.50
D011665 Pulmonary Valve Insufficiency NIH 0.27
D006333 Heart Failure NIH 0.24
D007249 Inflammation NIH 0.14
D013577 Syndrome NIH 0.07
D055371 Acute Lung Injury NIH 0.07
D012127 Respiratory Distress Syndrome, Newborn NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D003141 Communicable Diseases NIH 0.06
D011014 Pneumonia NIH 0.04
D007239 Infection NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0100598 Pulmonary edema HPO 0.50
HP:0010444 Pulmonary insufficiency HPO 0.27
HP:0001635 Congestive heart failure HPO 0.24
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials


1 Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)

This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.

NCT04389944 Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) Other: convalescent plasma application to SARS-CoV-2 infected patients
MeSH:Communicable Diseases Infection Coronavirus Infections Clinical Deterioration

Primary Outcomes

Description: Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection

Measure: Serious adverse events in convalescent plasma treated patients

Time: From baseline (enrolment) to 24 hours follow-up

Description: Change in SARS-CoV2 quantitative in nasopharyngeal swab

Measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Description: Transfer to ICU

Measure: Transfer to ICU

Time: at Baseline (admission to Covid-ward) until day 28

Description: in-hospital death

Measure: in-hospital death

Time: at Baseline (admission to Covid-ward) until day 28

Description: Change in SARS-CoV2 quantitative in plasma

Measure: Virologic clearance in plasma of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Secondary Outcomes

Description: Duration of hospitalisation

Measure: Time to discharge from hospital after enrolment

Time: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)

Description: Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)

Measure: Humoral immune response

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

2 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of PB1046, a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.

NCT04433546 Acute Respiratory Distress Syndrome Coronavirus Hypoxic Respiratory Failure Hypoxemic Respiratory Failure Respiratory Complication Respiratory Insufficiency Cardiac Dysfunction Pneumonia Pulmonary Edema Pulmonary Inflammation Respiratory Failure Cytokine Storm COVID 19 SARS-CoV-2 Cardiac Event Cardiac Complication Cardiac Failure Cardiac Infarct Drug: PB1046 Drug: Low Dose (10 mg) Control
MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Edema Pulmonary Valve Insufficiency Heart Failure Syndrome Inflammation Clinical Deterioration
HPO:Congestive heart failure Left ventricular dysfunction Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure

Primary Outcomes

Measure: Days alive and free of respiratory failure from initiation of PB1046

Time: 28 days

Secondary Outcomes

Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)

Time: 28 days

Description: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen

Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization

Time: Any time point between injection initiation and Day 28

Measure: All-cause mortality

Time: 28 days

Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy

Measure: Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy

Time: 28 days

Measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.

Time: Any time point between injection initiation and Day 28

Measure: Change from baseline in cardiac marker high sensitivity troponin I (hsTnI)

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in cardiac marker NT-proBNP

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in TNF alpha

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-1

Time: Any time point between injection initiation and Day 35+7

Measure: Change from baseline in IL-6

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to PB1046

Time: Any time point between injection initiation and Day 35+7

Other Outcomes

Measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization

Time: Any time point between injection initiation and Day 35+7

Measure: Incidence of multi-system organ failure (MSOF)

Time: Any time point between injection initiation and Day 35+7

Measure: Number of multi-system organ failure (MSOF) free days

Time: Any time point between injection initiation and Day 35+7

Measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO)

Time: Any time point between injection initiation and Day 35+7


HPO Nodes