CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D007249: Inflammation NIH

(Synonyms: Infl, Infla, Inflam, Inflamm, Inflamma, Inflammati, Inflammatio, Inflammation)

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


Correlated Drug Terms (17)


Name (Synonyms) Correlation
drug802 Mavrilimumab Wiki 0.43
drug1622 oxyhydrogen Wiki 0.30
drug957 Oxygen Wiki 0.30
drug666 Immunological profiling Wiki 0.30
drug1309 Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki 0.30
drug783 MSC Wiki 0.30
drug424 Dexmedetomidine Injectable Product Wiki 0.30
drug75 Anakinra alone (stages 2b/3) Wiki 0.30
drug76 Anakinra and Ruxolitinib (overcome stage 3) Wiki 0.30
drug30 ABX464 Wiki 0.30
drug335 Colchicine Wiki 0.12
drug1285 Standard of care Wiki 0.08
drug1042 Placebos Wiki 0.08
drug1035 Placebo oral tablet Wiki 0.06
drug129 Azithromycin Wiki 0.06
drug1016 Placebo Wiki 0.05
drug591 Hydroxychloroquine Wiki 0.03

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D015817 Eye Infections NIH 0.30
D000071257 Emergence Delirium NIH 0.30
D003231 Conjunctivitis NIH 0.21
D003693 Delirium NIH 0.21
D013577 Syndrome NIH 0.08
D011014 Pneumonia NIH 0.06
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D011024 Pneumonia, Viral NIH 0.04
D014777 Virus Diseases NIH 0.04
D055371 Acute Lung Injury NIH 0.04
D012127 Respiratory Distress Syndrome, Newborn NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0000509 Conjunctivitis HPO 0.21
HP:0002090 Pneumonia HPO 0.07

There are 11 clinical trials

Clinical Trials


1 Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.

NCT04299152 Severe Acute Respiratory Syndrome (SARS) Pneumonia Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Inflammation
HPO:Pneumonia

Primary Outcomes

Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.

Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy

Time: 4 weeks

Secondary Outcomes

Description: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.

Measure: Chest imaging changes by computed tomography (CT) scan of the chest

Time: 4 weeks

Description: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.

Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR

Time: 4 weeks

2 Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

NCT04354584 COVID-19 Respiratory Failure
MeSH:Respiratory Insufficiency Inflammation

Primary Outcomes

Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

Measure: White blood cell counts

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

Measure: White blood cell counts

Time: Day 7

Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood

Measure: Lymphocyte populations

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood

Measure: Lymphocyte populations

Time: Day 7

Secondary Outcomes

Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)

Measure: Cytokines

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)

Measure: Cytokines

Time: Day 7

Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

Measure: Lectin complement pathway

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

Measure: Lectin complement pathway

Time: Day 7

Description: Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)

Measure: Microorganisms

Time: Up to 12 weeks

Description: Respiratory filmarray PCR for testing for pathogens

Measure: Respiratory pathogens

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Respiratory filmarray PCR for testing for pathogens

Measure: Respiratory pathogens

Time: Day 7

Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

Measure: Ribosomal RNA in the airways

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

Measure: Ribosomal RNA in the airways

Time: Day 7

Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

Measure: Levels of SARS-CoV-2 in the airways

Time: Day 0 (subsequent to study inclusion in the ICU)

Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

Measure: Levels of SARS-CoV-2 in the airways

Time: Day 7

Other Outcomes

Description: ICU mortality

Measure: Mortality

Time: Up to 6 months

Description: In hospital mortality

Measure: Mortality II

Time: Up to 6 months

Description: C-reactive protein, procalcitonin, ferritin

Measure: Blood markers of inflammation

Time: Daily assessment in the ICU up to 12 weeks

Description: Platelets, creatinine, urea, sodium, potassium, D-dimer, lactate dehydrogenase, bilirubin, lactate

Measure: Blood markers of organ dysfunction

Time: Daily assessment in the ICU up to 12 weeks

Description: Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram

Measure: Infiltrates on conventional chest x-ray

Time: Up to 12 weeks

3 Impact of Dexmedetomidine Infusion on the Time Course and Outcomes of Acute Respiratory Distress Syndrome (ARDS) in Patients Affected by the SARS-CoV-2 (COVID-19) Admitted to Critical Care Unit

A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series

NCT04358627 Acute Respiratory Distress Syndrome Inflammation Dexmedetomidine Cytokine Storm Delirium, Emergence Drug: Dexmedetomidine Injectable Product
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Delirium Emergence Delirium Syndrome Inflammation

Primary Outcomes

Description: (Presence/Absence) requirement of mechanical ventilation

Measure: Mechanical ventilation

Time: expected within first three days (non conclusive due to lack of evidence yet)

Secondary Outcomes

Description: Duration of mechanical ventilation if it is required (hours from the start)

Measure: Duration of mechanical ventilation

Time: expected within first seven days (non conclusive due to lack of evidence yet)

Description: Delirium criteria as defined in DSM-4

Measure: Delirium on recovery from sedation

Time: First 24 hours after retiring dexmedetomidine sedation

4 Interleukin-1 (IL-1) and Interferon Gamma (IFNg) Inhibition During COVID 19 Inflammation: Randomized, Controlled Study Assessing Efficacy and Safety of Anakinra and Ruxolitinib

During SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.

NCT04366232 Covid-19 Drug: Anakinra alone (stages 2b/3) Drug: Anakinra and Ruxolitinib (overcome stage 3) Other: Standard of care
MeSH:Inflammation

Primary Outcomes

Description: At least 3 parameters are met including CRP and/or Ferritin among: CRP: decrease > 50% Ferritinemia: decrease > 1/3 Serum creatinine: decrease > 1/3 AST/ALT: decrease > 50% Eosinophils > 50 /mm3 Lymphocytes > 1000 /mm3

Measure: Biological criteria

Time: 7 days from enrolment

Secondary Outcomes

Description: Number of days without mechanical ventilation

Measure: Duration of oxygen therapy (days)

Time: 28 days from enrolment

Description: Number of patients included in stage 2b

Measure: Number of intensive care units admissions

Time: 28 days from enrolment

Description: Number of days in intensive care units for patients managed in intensive care units

Measure: Number of days in intensive care units

Time: 28 days from enrolment

Description: Mortality rate

Measure: Mortality rate

Time: 28 days from enrolment

Description: Total number of days in hospital

Measure: Total number of days in hospital

Time: 28 days from enrolment

Description: Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score); Sofa score's minimum and maximum values are 0 and 24, the lowest score corresponds to a better outcome.

Measure: Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score)

Time: 28 days from enrolment

Description: Number of bacterial and/or fungal sepsis

Measure: Number of bacterial and/or fungal sepsis

Time: 28 days from enrolment

5 Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.

NCT04367168 COVID Drug: Colchicine Drug: Placebo oral tablet
MeSH:Inflammation

Primary Outcomes

Description: Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin

Measure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels

Time: Up to 24 days

Description: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg

Measure: Progression to severe disease

Time: Up to 10 days

6 Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients Presenting With Conjunctivitis to the Ophthalmology Clinics During the COVID-19 Pandemic

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.

NCT04374656 Conjunctivitis SARS-CoV-2 COVID-19 Ocular Infection, Viral Ocular Inflammation
MeSH:Eye Infections Eye Infections, Viral Conjunctivitis Inflammation Virus Diseases
HPO:Conjunctivitis

Primary Outcomes

Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples

Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2

Time: 1 year

Secondary Outcomes

Description: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

Description: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

Description: Number of patients developed COVID-19 divided by the number of the study population

Measure: Rate of development of COVID-19 in the study patient population

Time: 1 year

Description: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19

Measure: Positive conjunctival sample rate in patient developed COVID-19

Time: 1 year

7 Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS

To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

NCT04377334 ARDS COVID-19 Biological: MSC
MeSH:Inflammation

Primary Outcomes

Description: improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points

Measure: lung injury score

Time: day 10

Secondary Outcomes

Description: D-dimers blood levels

Measure: D-dimers

Time: day 0, 1, 2, 3, 10 and 15

Description: distribution of phenotypes of immune cells

Measure: phenotype

Time: day 0, 1, 2, 3, 10 and 15

Description: Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage

Measure: pro-resolving lipid mediators

Time: day 0, 1, 2, 3, 10 and 15

Description: Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions

Measure: cytokines

Time: day 0, 1, 2, 3, 10 and 15

Description: Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions

Measure: chemokines

Time: day 0, 1, 2, 3, 10 and 15

Description: Survival at 10 days and 28 days

Measure: Survival

Time: day 10 and 28

Description: Time to removal of endotracheal tube

Measure: extubation

Time: day 28

Description: lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)

Measure: lymphocyte subpopulations

Time: day 0, 3, 5 and 10

Description: evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.

Measure: SARS-CoV-2-specific antibody titers

Time: day 0, 5 and 10

Description: evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion

Measure: complement molecules (C5-C9)

Time: day 0, 5 and 10

8 A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.

A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

NCT04393038 COVID-19 Drug: ABX464 Drug: Placebo
MeSH:Respiratory Insufficiency Inflammation

Primary Outcomes

Measure: Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive

Time: at the end of the 28-day treatment period

Secondary Outcomes

Measure: Rate of patients hospitalized

Time: 28-day treatment period

Description: 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death

Measure: Percentage of patients reporting each severity rating on a 7-point ordinal scale

Time: 28-day treatment period

Measure: Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs

Time: at each study visit during the 28-day treatment period

Measure: Rate of patients requiring oxygen supplementation

Time: 28-day treatment period

Measure: Time to hospitalization

Time: 28-day treatment period

Measure: Time to assisted ventilation and oxygen supplementation

Time: 28-day treatment period

Measure: Change from baseline in microRNA-124 levels

Time: at each study visit during the 28-day treatment period

Measure: Change from baseline in CRP, Troponin I & T and D-dimer

Time: at each study visit during the 28-day treatment period

Description: Nasopharyngeal sample and/or in blood

Measure: SARS-CoV-2 viral load

Time: at each study visit during the 28-day treatment period

Measure: Number and rates of participants with Treatment Emergent Adverse Event

Time: 28-day treatment period

9 A Randomized, Double Blind, Placebo-controlled Trial of Mavrilimumab for Acute Respiratory Failure Due to COVID-19 Pneumonia With Hyper-inflammation (the COMBAT-19 Trial)

This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.

NCT04397497 Covid-19 Acute Respiratory Failure ARDS, Human Sars-CoV2 Viral Pneumonia Drug: Mavrilimumab Drug: Placebo
MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan- Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm

Measure: Reduction in the dependency on oxygen supplementation

Time: within day 14 of treatment

Secondary Outcomes

Description: Response is defined as a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Proportion of responders (using the WHO 7-point ordinal scale)

Time: Day 7, 14, and 28

Description: Time from date of randomization to the date with a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen

Measure: Time to response (using the WHO 7-point ordinal scale)

Time: Within day 28 of intervention

Description: Proportion of patients with at least two-point improvement in clinical status

Measure: Proportion of improving patients (using the WHO 7-point ordinal scale)

Time: At day 7, 14, and 28

Description: Time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner

Measure: Time to resolution of fever

Time: Within day 28 of intervention

Description: COVID-19-related death

Measure: Reduction in case fatality

Time: Within day 28 of intervention

Description: Proportion of hospitalized patients who died or required mechanical ventilation (WHO Categories 6 or 7)

Measure: Proportion of patient requiring mechanical ventilation/deaths

Time: Within day 14 of intervention

Description: Change of the following serological markers over follow-up (C-reactive protein; Ferritin; D-Dimer)

Measure: Change in biochemical markers

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Median changes of NEWS2 score from baseline

Measure: Median changes in the National Early Warning Score 2 (NEWS2)

Time: At day 7, 14, and 28

Description: Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first)

Measure: Time to clinical improvement as evaluated with the National Early Warning Score 2 (NEWS2)

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Variations from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern,parenchymal consolidations, and evolution towards fibrosis.

Measure: Variations in radiological findings

Time: Within day 28 of intervention or discharge -whatever comes first

Description: Number of patients with treatment- related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: By day 84

Other Outcomes

Description: To evaluate the primary and secondary endpoints in different subgroups of patients: mild respiratory failure: PaO2/FiO2 ≤ 300 and > 200 mmHg; moderate respiratory failure: PaO2/FiO2 ≤ 200 and > 100 mmHg

Measure: Clinical efficacy of mavrilimumab compared to the control arm by clinical severity

Time: Within day 28 of intervention

Description: Median changes in serum IL-6

Measure: Changes in serum IL-6 (exploratory biomarker)

Time: By day 84

Description: Median changes in serum IL-1 receptor antagonist

Measure: Changes in serum IL-1RA (exploratory biomarker)

Time: By day 84

Description: Median changes in serum TNF-alpha

Measure: Changes in serum TNF-alpha (exploratory biomarker)

Time: By day 84

Description: Median variations in haemoglobin and leucocyte counts

Measure: Changes in CBC + differential (exploratory biomarker)

Time: By day 84

Description: Median titres od anti-SARS-CoV2 antibodies

Measure: Level of anti-SARS-CoV2 antibodies (exploratory biomarker)

Time: By day 84

Description: Proportion of patients with a positive swab for SARS-CoV2 by PCR

Measure: Virus eradication (exploratory biomarker)

Time: By day 84

Description: Proportion of patients who developed anti-drug antibodies

Measure: Anti-drug antibodies (exploratory biomarker)

Time: By day 84

10 Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation

The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

NCT04399980 COVID 19 SARS-CoV 2 Pneumonia Drug: Mavrilimumab Drug: Placebos
MeSH:Pneumonia Respiratory Insufficiency Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Number of subjects alive and off of oxygen

Measure: Proportion of subjects alive and off of oxygen at day 14

Time: Day 14

Secondary Outcomes

Description: Number of subjects alive and without respiratory failure

Measure: Proportion of subjects alive and without respiratory failure at 28 days

Time: Day 28

11 Endothelial Function, Inflammation, and Organ Dysfunction in Critically Ill Patients With COVID-19

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients which require intensive care unit admission. In critically ill patients infected with COVID-19, approximately 15% had severe shock requiring medications to increase blood pressure. It appears that blood vessel tone is altered and microcirculation is not well regulated in patients with COVID-19. The underlying pathophysiology and contributing factors are unknown. The association with subsequent organ dysfunction and outcome is also unclear. Therefore, we aim to investigate serial changes of relevant biomarkers in this population to improve the understanding of this disease, to investigate the association with clinically important outcomes and to find out how best to treat patients. The data will serve to develop strategies for individualised management of this high-risk group.

NCT04408365 COVID Shock
MeSH:Inflammation

Primary Outcomes

Description: Plasma bio-adrenomedullin, proenkephalin, dipeptidyl peptidase-3, renin and angiotensin II

Measure: Plasma bio-adrenomedullin, proenkephalin, dipeptidyl peptidase-3, renin and angiotensin II

Time: Daily from admission, and around the onset of vasodilatory shock until day 7

Secondary Outcomes

Description: Duration of vasodilatory shock

Measure: Duration of vasodilatory shock

Time: 7 and 28 days

Description: As defined by the Kidney Disease: Improving Global Outcomes criteria

Measure: Acute kidney injury

Time: 7 and 28 days

Description: Need for renal replacement therapy

Measure: Need for renal replacement therapy

Time: 7 and 28 days

Description: Duration of ventilation

Measure: Duration of ventilation

Time: 7 and 28 days

Description: Duration of extracorporeal membrane oxygenation

Measure: Duration of extracorporeal membrane oxygenation

Time: 7 and 28 days

Description: ICU and hospital

Measure: Mortality

Time: 28 days


HPO Nodes