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D007249: Inflammation

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (42)


Name (Synonyms) Correlation
drug1936 Mavrilimumab Wiki 0.28
drug2603 Problem-solving and relationship improvement intervention. Wiki 0.19
drug225 Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki 0.19
Name (Synonyms) Correlation
drug2085 NK-1R antagonist Wiki 0.19
drug245 Antibody testing Wiki 0.19
drug1989 Methotrexate-LDE phase 1 Wiki 0.19
drug2400 Pemziviptadil (PB1046) Wiki 0.19
drug3890 nangibotide Wiki 0.19
drug1828 Low Dose (10 mg) Control Wiki 0.19
drug3865 mavrilimumab Wiki 0.19
drug786 Cognitive and behavioral intervention. Wiki 0.19
drug3178 Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki 0.19
drug210 Anakinra alone (stages 2b/3) Wiki 0.19
drug2990 Self-guided exercises Wiki 0.19
drug3538 Venous blood was collected for biochemistry testing. Wiki 0.19
drug2526 Placebo-LDE phase 2 Wiki 0.19
drug1006 Dexmedetomidine Injectable Product Wiki 0.19
drug2809 Respiratory physiotherapy Wiki 0.19
drug2473 Placebo Control Wiki 0.19
drug3470 UCMSCs Wiki 0.19
drug2354 PT-Pal Wiki 0.19
drug3038 Sham Device Treatment Wiki 0.19
drug286 Assessing antibody responses, neutralizing capacity and memory B-cell function Wiki 0.19
drug2429 Physical Exercises Wiki 0.19
drug2204 Non-invasive red LLLT treatment to chest of patient. Wiki 0.19
drug1990 Methotrexate-LDE phase 2 Wiki 0.19
drug2246 Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. Wiki 0.19
drug66 ABX464 Wiki 0.19
drug212 Anakinra and Ruxolitinib (overcome stage 3) Wiki 0.19
drug2771 Regadenoson Wiki 0.19
drug1893 MSC Wiki 0.13
drug3253 TD-0903 Wiki 0.13
drug1377 HB-adMSCs Wiki 0.13
drug152 Ad26.COV2.S Wiki 0.09
drug2532 Placebos Wiki 0.09
drug2448 Placebo Wiki 0.06
drug791 Colchicine Wiki 0.05
drug3943 placebo Wiki 0.05
drug1262 Favipiravir Wiki 0.04
drug3146 Standard of care Wiki 0.04
drug2514 Placebo oral tablet Wiki 0.03
drug3375 Tocilizumab Wiki 0.03

Correlated MeSH Terms (23)


Name (Synonyms) Correlation
D015817 Eye Infections NIH 0.19
D000071257 Emergence Delirium NIH 0.19
D013959 Thyroid Diseases NIH 0.13
Name (Synonyms) Correlation
D000075902 Clinical Deterioration NIH 0.13
D000073296 Noncommunicable Diseases NIH 0.13
D003231 Conjunctivitis NIH 0.13
D011654 Pulmonary Edema NIH 0.11
D011014 Pneumonia NIH 0.11
D003693 Delirium NIH 0.08
D002908 Chronic Disease NIH 0.08
D011665 Pulmonary Valve Insufficiency NIH 0.07
D006331 Heart Diseases NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.07
D006333 Heart Failure NIH 0.07
D055371 Acute Lung Injury NIH 0.06
D013577 Syndrome NIH 0.05
D012127 Respiratory Distress Syndrome, Newborn NIH 0.05
D008171 Lung Diseases, NIH 0.04
D018352 Coronavirus Infections NIH 0.04
D055370 Lung Injury NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D011024 Pneumonia, Viral NIH 0.02
D014777 Virus Diseases NIH 0.02

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0000820 Abnormality of the thyroid gland HPO 0.13
HP:0000509 Conjunctivitis HPO 0.13
HP:0002090 Pneumonia HPO 0.11
Name (Synonyms) Correlation
HP:0100598 Pulmonary edema HPO 0.11
HP:0010444 Pulmonary insufficiency HPO 0.07
HP:0001635 Congestive heart failure HPO 0.07
HP:0002088 Abnormal lung morphology HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 29 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
Conditions
  1. Severe Acute Respiratory Syndrome (SARS) Pneumonia
Interventions
  1. 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
Conditions
  1. COVID-19
  2. 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
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Inflammation
  3. Dexmedetomidine
  4. Cytokine Storm
  5. Delirium, Emergence
Interventions
  1. 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
Conditions
  1. Covid-19
Interventions
  1. Drug: Anakinra alone (stages 2b/3)
  2. Drug: Anakinra and Ruxolitinib (overcome stage 3)
  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
Conditions
  1. COVID
Interventions
  1. Drug: Colchicine
  2. 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
Conditions
  1. Conjunctivitis
  2. SARS-CoV-2
  3. COVID-19
  4. Ocular Infection, Viral
  5. Ocular Inflammation
MeSH:Eye Infections Virus Diseases Eye Infections, Viral Conjunctivitis Inflammation
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
Conditions
  1. ARDS
  2. COVID-19
Interventions
  1. 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
Conditions
  1. COVID-19
Interventions
  1. Drug: ABX464
  2. 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
Conditions
  1. Covid-19
  2. Acute Respiratory Failure
  3. ARDS, Human
  4. Sars-CoV2
  5. Viral Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. 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
Conditions
  1. COVID 19
  2. SARS-CoV 2
  3. Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. 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 that are alive

Measure: Proportion of subjects alive at 28 days

Time: Day 28

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 Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)

Background: COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it. Objective: To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection. Eligibility: People ages 18-80 with COVID-19 infection Design: Participants will be screened with a review of their medical records. Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests. Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein. Participants will have an ultrasound of the kidneys and heart. Participants will provide blood and urine samples. They will provide nasal swabs. Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction. Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid. Participants will have lung and heart function tests. At various points after recovery, participants will repeat many of these tests.

NCT04401449
Conditions
  1. Acute and Long Term Effects of COVID-19:on Systemic Inflammation
  2. Acute and Long Term Effects of COVID-19 on Lung Function
  3. Acute and Long Term Effects of COVID-19 on Mrain Function
  4. Acute and Long Term Effects of COVID-19 on Cardiac Function
  5. Acute and Long Term Effects of COVID-19 on Kidney Function
MeSH:Inflammation

Primary Outcomes

Description: Link inflammatory responses present in blood, urine and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain and kidneys) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.

Measure: Inflammatory responses of cells in lung and circulation

Time: From onset of illness in hospital through acute phase ( days 1 28 more or less 7), at the time of resolution of infection ( day 28 more or less 7 to 6 weeks, andduring convalescence (6 months to 1 year after the infection)
12 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19

This 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.

NCT04402866
Conditions
  1. Acute Lung Injury (ALI) Associated With COVID-19
  2. Lung Inflammation Associated With COVID-19
Interventions
  1. Drug: TD-0903
  2. Drug: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Number of Respiratory Failure-Free Days (RFDs) from randomization through Day 28

Measure: Part 2: Respiratory Failure-Free Days (RFDs)

Time: Baseline through Day 28

Secondary Outcomes

Description: Proportion of subjects in each category of the 8-point Clinical Status scale. The Clinical Status scale contains 8 different categories that are each assigned a numeric score. The values range from 1 (representing 'Not hospitalized, no limitations on activities') to 8 (representing 'Death'). The various measures describe hospitalization status and the various limitations and requirements for oxygen support.

Measure: Part 2: Clinical Status Scale

Time: Day 7, 14, 21 and 28

Description: Proportion of subjects alive and respiratory failure-free on Day 28

Measure: Part 2: Subjects alive and respiratory failure-free

Time: Day 28

Description: Change from baseline in SaO2/FiO2 ratio on Day 7

Measure: Part 2: SaO2/FiO2 ratio

Time: Baseline, Day 7
13 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, the investigators 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
Conditions
  1. COVID
  2. Shock
MeSH:Inflammation

Primary Outcomes

Description: Change of plasma bio-adrenomedullin

Measure: Change of plasma bio-adrenomedullin

Time: Day 1-7 after intensive care unit admission

Description: Change of plasma proenkephalin

Measure: Change of plasma proenkephalin

Time: Day 1-7 after intensive care unit admission

Description: Change of plasma dipeptidyl peptidase-3

Measure: Change of plasma dipeptidyl peptidase-3

Time: Day 1-7 after intensive care unit admission

Description: Change of plasma renin

Measure: Change of plasma renin

Time: Day 1-7 after intensive care unit admission

Description: Change of plasma angiotensin II

Measure: Change of plasma angiotensin II

Time: Day 1-7 after intensive care unit admission

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
14 A Nested Interventional Cohort Study to Assess the Efficacy and Safety of Adjunctive Humanized Monoclonal Interleukin-6 Receptor Blocker Tocilizumab (TCZ) Therapy to Standard of Care for the Reduction of Hyperinflammation Related Mortality in SARS-Cov2 Positive Patients

This is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.

NCT04423042
Conditions
  1. Covid19
  2. COVID-19
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Coronavirus
  5. Inflammation
Interventions
  1. Biological: Tocilizumab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Inflammation

Primary Outcomes

Description: Mortality status of participants

Measure: All-cause mortality

Time: Assessed at 30 days post treatment

Secondary Outcomes

Description: Uninfected, ambulatory, hospitalized: mild disease, hospitalized: severe disease, death

Measure: Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment.

Time: Assessed at days 3, 8, 15, 30, 60 post treatment
15 Exploratory Study of the Safety, Tolerability and Efficacy of Nangibotide in Mechanically Ventilated Patients With COVID-19 and Features of Systemic Inflammation A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features

This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo. All patients with a diagnosis of coronavirus disease 2019 (COVID-19), and a requirement for invasive mechanical ventilation will be considered for study participation. All study patients will receive standard of care treatment throughout the study. After screening for eligibility, patients will be randomized to one of two treatment arms. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of invasive mechanical ventilation. Patients will be treated for 5 days or until discharge from critical care, whichever is sooner. The treatment with study drug will be in addition to standard of care. A follow-up visit will be performed on days 8 and 14. The end of study visit is at day 28.

NCT04429334
Conditions
  1. COVID19
Interventions
  1. Drug: nangibotide
  2. Drug: placebo
MeSH:Inflammation

Primary Outcomes

Description: Incidence of adverse events until day 28

Measure: Adverse Events

Time: 28 days

Description: Incidence of mortality until day 28

Measure: Mortality

Time: 28 days
16 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (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 pemziviptadil (PB1046) by improving the clinical outcomes 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
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Coronavirus
  3. Hypoxic Respiratory Failure
  4. Hypoxemic Respiratory Failure
  5. Respiratory Complication
  6. Respiratory Insufficiency
  7. Cardiac Dysfunction
  8. Pneumonia
  9. Pulmonary Edema
  10. Pulmonary Inflammation
  11. Respiratory Failure
  12. Cytokine Storm
  13. COVID 19
  14. SARS-CoV-2
  15. Cardiac Event
  16. Cardiac Complication
  17. Cardiac Failure
  18. Cardiac Infarct
Interventions
  1. Drug: Pemziviptadil (PB1046)
  2. 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:Abnormal left ventricular function Congestive heart failure Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure

Primary Outcomes

Measure: Time to clinical recovery from initiation of pemziviptadil (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

Measure: Time to hospital discharge

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 troponin I (TrI)

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

Measure: Change from baseline in cardiac marker NT-proBNP/BNP

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 pemziviptadil (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 pemziviptadil (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 pemziviptadil (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 pemziviptadil (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 pemziviptadil (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

Measure: Change in circulating ferritin

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

Measure: Change in circulating D-dimer

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

Measure: Change in liver function

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

Measure: Change in other blood chemistry

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

Measure: Change in hematology

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

Measure: Change in inflammatory markers

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

Measure: Change in coagulation markers

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

Measure: Percent of clinical failure

Time: Any time point between injection initiation and Day 35+7
17 Assessment of Lung Inflammation With FDG PET/CT in COVID-19

The aim of the study was to assess the inflammatory status at the presumed peak of the inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of symptoms.

NCT04441489
Conditions
  1. COVID-19
  2. FDG PET/CT
  3. Inflammation
MeSH:Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)

Measure: Primary endpoint

Time: Day 6 to Day 14
18 Long-term Sequelae of Severe Sars-CoV-2 Infections

By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.

NCT04442789
Conditions
  1. Lung Diseases
  2. Cardiac Disease
  3. Inflammatory Reaction
MeSH:Lung Diseases Heart Diseases Inflammation
HPO:Abnormal lung morphology

Primary Outcomes

Description: Identify organ dysfunction after SARS-CoV-2 infections

Measure: Sequelae after COVID-19

Time: 12 months, extension if required
19 Nutritional Habits, Does it Affect Coronavirus Disease 2019 (COVID-19) Infection Outcome? An Egyptian Experience

As of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. Post viral entry, intense immune response against the virus with infiltration of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability, thrombosis and multiple organ damage, The gut microbiota and immune homeostasis seem to have a back and forth relationship. Also, gut microbiota derived signals are known to tune the immune cells for pro and anti-inflammatory responses thereby affecting the susceptibility to various diseases. Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system to prevent an array of excessive immune reactions that eventually become detrimental to lungs and vital organ systems. Numerous studies have shown that the patient's nutritional status have a significant effect on an individual's immunity and over all health status and it has been suggested that nutritional deficiencies may predispose to severe forms of COVID-19 infections. Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to delay patients recovery and worsen their prognosis, the reason may be due to aggravated inflammatory pathology found in NCDs exacerbating COVID-19 infection. The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients and whether type of diet (Mediterranean or Western) will affect disease outcomes

NCT04447144
Conditions
  1. Covid19
  2. Chronic Inflammation
  3. Non-Communicable Chronic Diseases
MeSH:Inflammation Chronic Disease Noncommunicable Diseases

Primary Outcomes

Description: To assess the relation between type of diet in mild to moderate COVID 19, to the fate of their course; either improvement or progression

Measure: Western versus Mediterranean diet in COVID-19 outcome

Time: 2 months

Description: To asses any possible links between gut microbiome and the lung affecting clinical presentation of mild to moderate COVID cases; as diarrhea, loss of taste or smell

Measure: Gut- Lung axis in COVID-19

Time: 2 months

Description: Possible protective effects of minerals and vitamins against COVID-19 respiratory illness

Measure: Protective role of minerals and vitamins in COVID-19 patients

Time: 2 months

Description: Trying to explain the link between non-communicable disease severity and COVID-19 prognosis

Measure: non-communicable diseases and COVID-19

Time: 2 months
20 A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

NCT04447469
Conditions
  1. COVID
Interventions
  1. Drug: mavrilimumab
  2. Other: Placebo
MeSH:Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Respiratory failure is defined as the need for high flow oxygen (HFO), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Measure: Cohort 1: Proportion of Participants Alive and Without Respiratory Failure at Day 15

Time: Day 15

Description: Mortality rate is defined as the proportion of participants who die.

Measure: Cohort 2: Mortality Rate at Day 15

Time: Day 15

Secondary Outcomes

Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (National Institute of Allergy and Infectious Diseases [NIAID] scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohort 1: Time to Return to Room Air by Day 15

Time: up to Day 15

Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohort 1: Time to 2-point Clinical Improvement by Day 15

Time: up to Day 15

Description: Mortality rate is defined as the proportion of participants who die.

Measure: Cohort 1: Mortality Rate at Day 29

Time: Day 29

Description: Clinical improvement, defined as time from randomization to a 1-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohort 1: Time to 1-Point Clinical Improvement by Day 15

Time: up to Day 15

Description: Mortality rate is defined as the proportion of participants who die.

Measure: Cohort 2: Mortality Rate at Day 29

Time: Day 29

Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO.

Measure: Cohort 2: Proportion of Participants Alive and Without Respiratory Failure at Day 15

Time: Day 15

Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO

Measure: Cohorts 1 and 2: Proportion of Participants Alive and Without Respiratory Failure At Day 29

Time: Day 29

Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohorts 1 and 2: Time to Return to Room Air by Day 29

Time: up to Day 29

Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohort 2: Time to 2-point Clinical Improvement by Day 15

Time: up to Day 15

Description: Clinical Improvement, defined as time from randomization to a 1-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohorts 1 and 2: Time to 1-point Clinical Improvement by Day 29

Time: up to Day 29

Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohorts 1 and 2: Time to 2-point Clinical Improvement by Day 29

Time: up to Day 29

Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO.

Measure: Cohort 1: Respiratory Failure-Free Survival by Day 15

Time: up to Day 15

Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO

Measure: Cohort 1: Respiratory Failure-Free Survival by Day 29

Time: up to Day 29

Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohort 1: Proportion of Participants Who Return to Room Air by Day 15

Time: up to Day 15

Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohorts 1 and 2: Proportion of Participants Who Return to Room Air by Day 29

Time: up to Day 29

Description: Mortality rate is defined as the proportion of participants who die.

Measure: Cohort 1: Mortality Rate at Day 15

Time: Day 15

Description: Overall survival is defined as time from date of randomization to the date of death.

Measure: Cohorts 1 and 2: Overall Survival by Day 29

Time: up to Day 29

Description: Clinical status, based on the NIAID 8-point ordinal scale. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.

Measure: Cohorts 1 and 2: Clinical Status Over Time

Time: Days 4, 8, 15, 22, and 29

Measure: Cohorts 1 and 2: Number of Days Alive and Out of Hospital Through Day 90

Time: through Day 90
21 The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Coronavirus Disease 2019

COVID-19 is a new disease and therefore it is still not clear exactly how the virus affects the body and why people are affected so differently. It causes infection in the lungs and the virus can then attack blood vessels in the lungs and other organs to spark off an inflammatory process that can make a person very ill. It also can cause damage within tiny blood vessels that makes a person's blood thicken up and stop flow in vital organs. The investigators believe complement (which is a chemical in the body which can be harmful in excess) orchestrates the inflammation and thickening of the blood that can make a person sick. The investigators now need to know which of these complement chemicals are elevated in COVID-19 and compare to healthy volunteers, and assess whether the levels are higher in people with severe lung disease. The investigators believe that if levels are increased there are special treatments that can counteract them and potentially be an effective treatment for COVID-19. In this study the investigators will measure different parts of the inflammation process to better understand what may be causing severe disease and to see if there may be benefits from a new treatment to reduce inflammation

NCT04453527
Conditions
  1. Coronavirus
MeSH:Coronavirus Infections Inflammation

Primary Outcomes

Description: C5a, C5, C3, sC5b9, Bb concentration from serum

Measure: Complement Activation

Time: 14 days sampling time period

Description: LTB4 concentration from plasma

Measure: Leukotrienes Measure

Time: 14 days sampling time period

Description: Level of platelets, INR, APTS, D-Dimer, Fibrinogen, thrombin antithrombin complex (TAT), from citrate plasma

Measure: Coagulation Measure

Time: 14 days sampling time period

Description: • CRP, Ferritin, PCT, LDH, Troponin, ALT from plasma

Measure: Hyperinflammation Measure

Time: 14 days sampling time period

Description: Total White Blood Cell count (including lymphocytes, monocytes and neutrophils)

Measure: Cell Count

Time: 14 days sampling time period

Description: Level of • Pro-inflammatory - IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-7, IL-8, IL-17, GCSF, GMCSF, IFN γ, IP10, MCP-1, MIP1α, TNFα and anti inflammatory IL-4, IL-10, IL-13, IL-22, TGF-α from plasma

Measure: Cytokines and Chemokine Measure

Time: 14 days sampling time period

Description: VEGF, tissue factor and PAI-1, from plasma

Measure: Endothelial dysfunction measures:

Time: 14 days sampling time period
22 Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.

NCT04455347
Conditions
  1. COVID-19 Infection
MeSH:Inflammation

Primary Outcomes

Description: Description of imaging data from MRI ans CT scan and associated clinical data.

Measure: Imaging data at Baseline

Time: Baseline

Description: Description of imaging data from MRI ans CT scan and associated clinical data.

Measure: Imagine data at Follow-up

Time: During the 2 years follow-up period
23 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.

NCT04463004
Conditions
  1. COVID-19
  2. Sars-CoV2
  3. Pneumonia
Interventions
  1. Drug: Mavrilimumab
  2. 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: 14 days

Secondary Outcomes

Description: Number of subjects alive and without respiratory failure

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

Time: 28 days
24 To Determine the Efficacy of Neurokinin 1 Receptor Antagonist as a Therapeutic Tool Against Cytokine Storm and Respiratory Failure in Covid-19 Patients

This is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

NCT04468646
Conditions
  1. Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammatio
  2. Neurokinin 1 Receptor, Substance P, Respiratory Illness, Inflammation, Covid-19, Coronavirus
Interventions
  1. Drug: NK-1R antagonist
MeSH:Coronavirus Infections Respiratory Insufficiency Inflammation

Primary Outcomes

Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

Time: 14 days or discharge

Secondary Outcomes

Measure: total in-hospital days and the total duration

Time: 14 days or discharge

Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

Time: 14 days or discharge

Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

Measure: Time to normalization of fever for at least 48 hours

Time: 14 days or discharge

Measure: Time to improvement in oxygenation for at least 48 hours

Time: 14 days or discharge
25 Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

NCT04490486
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
  3. Corona Virus Infection
Interventions
  1. Biological: UCMSCs
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.

Measure: Percent of participants with treatment related Serious Adverse Events (SAE)

Time: 12 months

Secondary Outcomes

Description: Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.

Measure: Change in inflammatory marker levels

Time: Baseline, Day 30

Description: Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.

Measure: Change in systemic inflammatory marker levels

Time: Baseline, Day 30

Description: Assessed using blood samples or nose/throat swabs.

Measure: COVID-19 Viral Load

Time: Up to 30 Days

Description: Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.

Measure: Change in SOFA score

Time: Baseline, Up to 30 Days

Description: Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.

Measure: Change in electrolytes levels

Time: Baseline, Up to 30 Days

Description: Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.

Measure: Change in LDH levels

Time: Baseline, Up to 30 Days

Description: ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.

Measure: Number of subjects discharged from the ICU

Time: Up to 7 Days

Description: Percentage of participants requiring less use of vasoactive agents will be reported.

Measure: Percentage of participants with less requirement for vasoactive agents

Time: Up to 30 Days

Description: Percentage of participant deaths throughout the study period.

Measure: Rate of Mortality

Time: Up to 30 Days

Description: The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.

Measure: Percentage of participants with changes in immune marker expression

Time: Up to 30 Days

Description: Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).

Measure: Percentage of participants with changes in radiologic findings

Time: Up to 30 Days

Description: Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.

Measure: Percentage of participants with less pneumonia symptoms

Time: Up to 30 Days
26 Low-Level Laser Therapy Treatment of Lung Inflammation in COVID-19 Patients

To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.

NCT04524715
Conditions
  1. Covid19
Interventions
  1. Device: Non-invasive red LLLT treatment to chest of patient.
  2. Device: Sham Device Treatment
MeSH:Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Change in inflammation of the lungs as measured by O2 saturation levels

Measure: Inflammation of the lungs - O2

Time: 10 days

Description: Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test

Measure: Inflammation of the lungs - CRP

Time: 10 days

Description: Change in inflammation of the lungs as measured by IL-6 Levels

Measure: Inflammation of the lungs - IL6

Time: 10 days
27 Clinical Trial on the Safety and Efficacy of Regadenoson for Moderate to Severe COVID-19 Adult Patients

More than 17 million people have been infected and more than 677K lives have been lost since the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung injury and need oxygen therapy, and even ventilators, to help them breathe. When a person gets a viral infection, certain body cells (inflammatory/immune cells) get activated and release a wide range of small molecules, also known as cytokines, to help combat the virus. But it is possible for the body to overreact to the virus and release an overabundance of cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed, these cytokines cause more damage to their own cells than to the invading COVID-19 that they're trying to fight. Recently, doctors and research scientists are becoming increasingly convinced that, in some cases, this is likely what is happening in the moderate to severe COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control the formation of cytokine storms will also help alleviate the symptoms and aid in the recovery of severe COVID-19 patients.

NCT04606069
Conditions
  1. COVID-19
  2. Lung Inflammation
Interventions
  1. Drug: Regadenoson
  2. Other: Placebo Control
MeSH:Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities: 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 or CPAP Whether patient is on ECMO

Measure: Proportion of patients alive and free of respiratory failure through the 30-day trial.

Time: 30 Days

Secondary Outcomes

Description: We will collect blood samples of the regadenoson and placebo treated patients at the baseline, 30mins, 4 hours during drug infusion and 12 hour post drug infusion. It may also including the daily blood collected on normal standard care base. The inflammatory cytokines, including IL-1 beta, IL-6, IL-4, IL-8, IL-10, IL-12, IL-17, TNF-α, and IFN-γ will be measured using the Luminex™ 100 Multi-analyte System at The UM SOM Cytokine Core Laboratory. The levels of of cytokines will be measure in picogram/milliliter (pg/ml).

Measure: Change of the levels of the inflammatory cytokines prior, during and post drug infusion.

Time: 30 days

Description: The same blood samples used in outcomes 2 will be used to measure the levels of matrix metalloproteinase-2 (MMP-2) and MMP-9 using gelatin zymography as described in our previous publications (Zhao et al, 2010 & 2011). The enzyme levels will be quantified using The Image Lab 5.1 software. The unit will be nanogram/ml (ng/ml).

Measure: Change of the levels of MMP-2 and MMP-9 prior, during and post drug infusion.

Time: 30 days
28 Two Phases Clinical Trial to Evaluate Safety and Efficacy of Methotrexate Associated to LDL Like Nanoparticles (LDE-MTX) in the Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease.

The investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease. A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.

NCT04610567
Conditions
  1. Coronavirus
  2. Inflammation
  3. Covid19
Interventions
  1. Drug: Methotrexate-LDE phase 1
  2. Drug: Methotrexate-LDE phase 2
  3. Drug: Placebo-LDE phase 2
MeSH:Coronavirus Infections Inflammation

Primary Outcomes

Description: Compare the duration of hospital stay between groups

Measure: Duration of hospital stay

Time: 30 days after randomization

Secondary Outcomes

Description: The secondary outcome is the need for mechanical ventilation between groups

Measure: Number of participants requiring mechanical ventilation

Time: 15 days after randomization

Description: The secondary outcome is the need for vasoactive drugs between groups

Measure: Number of participants requiring vasoactive drugs

Time: 15 days after randomization

Description: The secondary outcome is the need for renal replacement therapy between groups

Measure: Number of participants requiring renal replacement therapy

Time: 15 days after randomization

Description: The secondary outcome is the incidence of secondary infection between groups

Measure: Incidence of secondary infection

Time: 15 days after randomization

Description: The secondary outcome is the comparison of Sequential Organ Failure Assessment (SOFA) score between groups

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: Baseline and change from baseline to 15 days after randomization

Description: The secondary outcome is the comparison of World Health Organization (WHO) COVID-19 clinical score between groups

Measure: World Health Organization (WHO) COVID-19 score

Time: Baseline and change from baseline to 15 days after randomization

Description: The secondary outcome is the comparison of IL-6 levels between groups

Measure: Interleukin 6 (IL-6)

Time: Baseline and change from baseline to 15 days after randomization

Description: The secondary outcome is the comparison of dimer-D levels between groups

Measure: Dimer-D

Time: Baseline and change from baseline to 15 days after randomization

Description: The secondary outcome is the comparison of chest CT scan between groups

Measure: Chest CT scan

Time: Baseline and change from baseline to 15 days after randomization

Description: The secondary outcome is the comparison of red blood cells; white blood cells;Platelets; Urea;Creatinine levels between groups

Measure: Incidence and severity of laboratory alterations

Time: 30 days after randomization

Description: Compare the incidence of clinical significant symptoms (new and persistent stomatitis, vomiting, diarrhea, alopecia, neurotoxicity, bradycardia, hypotension, local pain) reported between groups.

Measure: Clinical side effects

Time: 30 days after randomization

Description: Compare the incidence of other adverse events (not expected) between groups

Measure: Other adverse events

Time: 30 days after randomization
29 Thyroid Function Tests and the Status of Thyroid Autoantibodies in Hospitalized Covid-19 Patients and Their Relationship With White Blood Cells, Neutrophil / Lymphocyte Ratio, c Reactive Protein, Fibrinogen, Procalcitonin, Ferritin and D-dimer

COVID-19 infection causes a hypersensitive immune reaction and widespread inflammation through cytokines in various organs of the body, especially the lungs. This cytokine-mediated widespread inflammation can also affect the thyroid gland, causing thyroiditis and impaired thyroid functions. The researchers evaluated thyroid function tests and thyroid autoantibodies in patients hospitalized for COVID-19 infection. Researchers excluded patients on intensive care therapy and patients with known thyroid disease. The researchers examined the relationship of thyroid hormones and thyroid autoantibodies to COVID-19 disease, white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer stages in these patients. Researchers compared changes in thyroid hormones and autoantibodies in people without COVID-19 infection and without thyroid disease.

NCT04659200
Conditions
  1. COVID-19 Infection
  2. Thyroid Function Tests
  3. Inflammation; Thyroid
  4. Inflammatory Markers
Interventions
  1. Diagnostic Test: Venous blood was collected for biochemistry testing.
MeSH:Thyroid Diseases Inflammation
HPO:Abnormality of the thyroid gland

Primary Outcomes

Description: In the study, serum TSH results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

Measure: Comparison of thyroid stimulating hormone (TSH) between groups

Time: 90 days

Description: In the study, serum fT3 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

Measure: Comparison of free triiodothyronine (fT3) between groups

Time: 90 days

Description: In the study, serum fT4 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

Measure: Comparison of free thyroxine (fT4) between groups

Time: 90 days

Description: In the study, serum anti-TPO results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

Measure: Comparison of anti-thyroid peroxidase (Anti-TPO) between groups

Time: 90 days

Description: In the study, serum anti-Tg results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

Measure: Comparison of anti-thyroglobulin (Anti-Tg) between groups

Time: 90 days

Description: In the study, serum WBC results were recorded in Covid 19 patient groups.

Measure: White blood cells (WBC) results of Covid 19 patient group

Time: 90 days

Description: In the study, serum N/LO results were recorded in Covid 19 patient groups.

Measure: Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group

Time: 90 days

Description: In the study, serum CRP results were recorded in Covid 19 patient groups.

Measure: C-reactive protein (CRP) results of Covid 19 patient group

Time: 90 days

Description: In the study, serum fibrinogen results were recorded in Covid 19 patient groups.

Measure: Fibrinogen results of Covid 19 patient group

Time: 90 days

Description: In the study, serum procalcitonin results were recorded in Covid 19 patient groups.

Measure: Procalcitonin results of Covid 19 patient group

Time: 90 days

Description: In the study, serum ferritin results were recorded in Covid 19 patient groups.

Measure: Ferritin results of Covid 19 patient group

Time: 90 days

Description: In the study, serum D-dimer results were recorded in Covid 19 patient groups.

Measure: D-dimer results of Covid 19 patient group

Time: 90 days

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 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  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook