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D018450: Disease Progression

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 (27)


Name (Synonyms) Correlation
drug10 0.9% sodium chloride (normal saline) Wiki 0.24
drug2974 SARS-CoV-2 viral composition Wiki 0.24
drug2929 Rt PCR Wiki 0.24
Name (Synonyms) Correlation
drug2301 Octagam 10% Wiki 0.24
drug1804 LYMPHOCYTE MONOCYTE RATIO Wiki 0.24
drug2420 Pamrevlumab Wiki 0.24
drug716 Camostat Wiki 0.24
drug3673 Vitamin B12 Wiki 0.24
drug3441 The control group will not receive hydroxychloroquine Wiki 0.24
drug281 Apilimod Dimesylate Capsule Wiki 0.24
drug408 BIOVITALS Wiki 0.24
drug3330 T-cell receptor (TCR) repertoire Wiki 0.24
drug3722 Whole Genome Analysis Wiki 0.24
drug2764 RBT-9 (90 mg) Wiki 0.24
drug3751 Zinc Citrate Wiki 0.24
drug2880 Respiratory rehabilitation Wiki 0.24
drug2414 PUL-042 Inhalation Solution Wiki 0.17
drug3812 blood sample Wiki 0.17
drug1434 HCQ Wiki 0.12
drug632 COVID-19 Convalescent Plasma Wiki 0.11
drug3678 Vitamin D3 Wiki 0.10
drug1520 Hydroxychloroquine Wiki 0.07
drug3674 Vitamin C Wiki 0.07
drug2037 Methylprednisolone Wiki 0.06
drug2505 Placebo Wiki 0.05
drug3485 Tocilizumab Wiki 0.04
drug364 Azithromycin Wiki 0.04

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D007239 Infection NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 18 clinical trials


1 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

NCT04313023
Conditions
  1. COVID-19
Interventions
  1. Drug: PUL-042 Inhalation Solution
  2. Drug: Placebo
MeSH:Infection Disease Progression

Primary Outcomes

Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

Description: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 28 days

Description: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 14 days

Description: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 14 days

Description: The requirement for ICU admission within 28 days from the start of experimental therapy.

Measure: ICU admission

Time: 28 days

Description: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

Measure: Mechanical ventilation

Time: 28 days

Description: All cause mortality at 28 days from the start of experimental therapy.

Measure: Mortality

Time: 28 days
2 Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death

This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.

NCT04323631
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Other: The control group will not receive hydroxychloroquine
MeSH:Infection Disease Progression

Primary Outcomes

Description: Number patients developing severe infection or death

Measure: Number patients developing severe infection or death

Time: within 28 days
3 Using Biovitals® Sentinel to Monitor Disease Progression in Subjects Quarantined for Suspected COVID-19

The novel coronavirus (COVID-19) emerged in December 2019, and in mere months has spread to more than 104 countries, resulting in an outbreak of viral pneumonia worldwide. Current local quarantine policy in Hong Kong for individuals suspected for COVID-19 requires daily self-reported symptomatology and body temperature, given the intermittent nature and the high dependency of self-discipline undermine the practicality of the approach. To date, the advance in sensor technology has made possible to continuously monitor individual physiological parameters using a simple wearable device. Together with the mobile wearable technology that allowing instantaneous, multi-directional, and massive data transfer, remote continuous physiological monitoring is made possible. The Cardiology division, the Univeristy of Hong Kong has been in collaboration with Biofourmis to implement such technology for remote heart failure management. Similar digital therapeutic system can be applied to remotely monitor physiological parameters of large number of quarantined or suspected COVID-19 at home or in quarantine facility. It is purposed to allow the monitoring team to effectively and remotely monitor COVID-19 quarantined and patients, manage and evaluate the disease progression.

NCT04343794
Conditions
  1. COVID19
Interventions
  1. Device: BIOVITALS
MeSH:Disease Progression

Primary Outcomes

Description: Time from quarantine to diagnosis of COVID-19

Measure: Time to diagnosis of COVID-19 by RT-PCR in subjects

Time: within 14 days

Secondary Outcomes

Description: Adherence to device

Measure: Compliance to complete the study

Time: within 14 days

Description: To identify COVID19 subjects

Measure: Sensitivity and specificity of Biovitals® Sentinel

Time: within 14 days

Description: % of family members infection

Measure: Cross infection rate within the family cluster

Time: within 14 days

Description: Length of hospital stay

Measure: Length of hospital stay of positive subjects

Time: 1 year at study completion

Description: Length of ICU stay

Measure: Length of ICU stay of positive patients

Time: 1 year at study completion

Description: Vital signs of positive patients

Measure: National Early Warning Score 2 rating of positive patients

Time: 4 weeks from diagnosis

Description: Virology laboratory result of nasopharyngeal swab

Measure: Viral load of positive patients

Time: 4 weeks from diagnosis

Description: Worsening of comorbidities

Measure: Worsening of comorbidities

Time: 1 year at study completion

Description: Mortality

Measure: Mortality

Time: 1 year at study completion
4 An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study. Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.

NCT04345445
Conditions
  1. COVID-19
Interventions
  1. Drug: Tocilizumab
  2. Drug: Methylprednisolone
MeSH:Disease Progression

Primary Outcomes

Measure: The proportion of patients requiring mechanical ventilation

Time: Through study completion, and average of 6 months

Measure: Mean days of ventilation

Time: Through study completion, and average of 6 months

Secondary Outcomes

Measure: The proportion of patients requiring ICU admission

Time: Through study completion, and average of 6 months

Measure: Overall 28-day survival

Time: 28 day from baseline

Measure: Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline

Time: 7 days from baseline

Measure: Duration of hospital and ICU stay

Time: Through study completion, and average of 6 months
5 A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)

The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.

NCT04364763
Conditions
  1. COVID-19
Interventions
  1. Drug: RBT-9 (90 mg)
  2. Drug: 0.9% sodium chloride (normal saline)
MeSH:Disease Progression

Primary Outcomes

Description: Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which measures the clinical status of a subject at the first assessment of a given day with category 1, most favorable, and category 8, least favorable (1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support - pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]; 8. Death)

Measure: Evaluate the effect of RBT-9 versus placebo on clinical status of COVID-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale

Time: 28 days

Secondary Outcomes

Description: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through Day 28, defined as at least one of the following: 1. Respiratory decompensation; 2. New or worsening congestive heart failure; 3. Requirement of vasopressor therapy and/or inotropic or mechanical circulatory support; 4. Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest; 5. Initiation of renal replacement therapy

Measure: Time to first occurrence of death from any cause or new/worsened organ dysfunction

Time: 28 Days

Description: Percentage of subjects who are alive at Day 28

Measure: All-cause survival

Time: 28 Days

Description: Among subjects who begin oxygen therapy, mean change from initiation to last day on oxygen or Day 28 (whichever happens first) in SpO2/FiO2 ratio

Measure: Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio

Time: 28 Days

Description: Percentage of subjects with fever through Day 28

Measure: Fever incidence

Time: 28 Days

Description: Percentage of subjects who develop AKI (defined as an increase in serum creatinine by 0.5 mg/dL or more within 48 hours or an increase in serum creatinine to 1.5 × Baseline or more within the last 7 days) through Day 28

Measure: Acute kidney injury (AKI) incidence

Time: 28 Days

Description: Percentage of subjects with new or worsening congestive HF through Day 28

Measure: New or worsening congestive heart failure (HF)

Time: 28 Days

Description: Percentage of subjects who remain hospitalized at Day 28

Measure: Hospitalization status

Time: 28 Days

Description: Percentage of subjects with ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest through Day 28

Measure: Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest

Time: 28 Days

Description: Number of oxygen-free days through Day 28

Measure: Oxygen-free days

Time: 28 Days

Description: Percentage of subjects transferred to the ICU through Day 28

Measure: Intensive care unit (ICU) status

Time: 28 Days

Description: Number of days on mechanical ventilation through Day 28

Measure: Days on ventilator

Time: 28 Days

Description: Time to and duration of vasopressor or inotrope utilization through Day 28

Measure: Time to and duration of vasopressor or inotrope utilization

Time: 28 Days

Description: Percentage of subjects who begin dialysis through Day 28

Measure: Dialysis status

Time: 28 Days
6 NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression

In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .

NCT04364828
Conditions
  1. COVID-19
Interventions
  1. Genetic: Whole Genome Analysis
  2. Genetic: T-cell receptor (TCR) repertoire
  3. Genetic: SARS-CoV-2 viral composition
MeSH:Disease Progression

Primary Outcomes

Description: The change in the genetic makeup of a virus population (measured in numbers) as the viruses mutate and multiply over time at different time points

Measure: Viral evolution

Time: Day 1, Day 3-5, Day 7-9, 48 hours after recovery

Secondary Outcomes

Description: CD4+ and CD8+ T cells from blood (per µl) at different time points measured

Measure: Immune response

Time: Day 1, Day 3-5, Day 7-9, 48 hours after recovery

Description: Clinical classification according to severity: Light and uncomplicated (mild symptoms) Moderate (mild pneumonia) Severe pneumonia Critical (Acute Respiratory Distress Syndrome (ARDS), sepsis, septic shock) Evaluated at several time points

Measure: Disease severity

Time: Day 1, Day 3-5, Day 7-9, 48 hours after recovery
7 Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients

SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.

NCT04369456
Conditions
  1. Kidney Transplant; Complications
  2. Coronavirus Infection
Interventions
  1. Other: blood sample
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Disease Progression

Primary Outcomes

Description: quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.

Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation

Time: 10 months
8 Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Chronic Haemodialysis Patients

SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis the investigators formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigators propose to follow recently infected chronic haemodialysis patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The investigators plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 chronic haemodialysis patients with moderate symptoms followed in 9 centers.

NCT04371510
Conditions
  1. COVID-19 by SARS-CoV-2 Infection
Interventions
  1. Other: blood sample
MeSH:Disease Progression

Primary Outcomes

Description: Quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 patients.

Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation

Time: 10 months
9 Early transfusIon of COVID-19 Convalescent Plasma in Elderly COVID-19 Patients to Prevent Disease Progression.

Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality. The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus. The objective of this study are: - To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone - To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities - To decrease viral load - To raise anti-SARS-CoV-2 antibody titer in recipients

NCT04374526
Conditions
  1. Coronavirus Disease 2019 )COVID-19)
Interventions
  1. Biological: COVID-19 Convalescent Plasma
MeSH:Disease Progression

Primary Outcomes

Description: Proportion of patients without progression in severity of pulmonary disease defined as worsening of 2 points in the ordinal scale of WHO within day 14

Measure: Rate of COVID-19 progression

Time: days 1 to 14.
10 Therapies to Prevent Progression of COVID-19, Including Hydroxychloroquine, Azithromycin, Zinc, Vitamin D, Vitamin B12 With or Without Vitamin C, a Multi-centre, International, Randomized Trial: The International ALLIANCE Study

COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients.

NCT04395768
Conditions
  1. COVID19
Interventions
  1. Dietary Supplement: Vitamin C
  2. Drug: Hydroxychloroquine
  3. Drug: Azithromycin
  4. Dietary Supplement: Zinc Citrate
  5. Dietary Supplement: Vitamin D3
  6. Dietary Supplement: Vitamin B12
MeSH:Disease Progression

Primary Outcomes

Description: Composite measure: Change in severity and duration of symptoms

Measure: Symptoms

Time: once daily for 15 days since enrollment/baseline at admission to hospital

Description: total number of days in hospital since admission

Measure: Length of hospital stay

Time: at 15 and 45 days since admission/ enrolment

Description: need for invasive mechanical ventilation or mortality within 15 days from enrolment

Measure: invasive mechanical ventilation or mortality

Time: any time within 15 days from enrolment

Secondary Outcomes

Description: Death

Measure: Mortality

Time: 15 and 45 days since enrolment

Description: need for and number of days of invasive mechanical ventilation, in case of no need for mechanical ventilation: days=0

Measure: mechanical ventilation

Time: at 15 and 45 days since enrolment

Description: need for and number of days for humidified high-flow oxygen

Measure: oxygen

Time: 15 and 45 days since enrolment

Description: admission to ICU (intensive care unit)

Measure: ICU

Time: 15 and 45 days since enrolment

Description: days in hospital

Measure: days in hospital

Time: 15 and 45 days since enrolment

Description: days in ICU

Measure: days in ICU

Time: 15 and 45 days since enrolment

Description: need for and days of renal replacement therapy

Measure: renal replacement therapy

Time: 15 and 45 days since enrolment

Description: need for and days of Extracorporeal support

Measure: Extracorporeal support

Time: 15 and 45 days since enrolment
11 Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease

NCT04400058
Conditions
  1. Covid-19
Interventions
  1. Biological: Octagam 10%
  2. Other: Placebo
MeSH:Disease Progression

Primary Outcomes

Description: Proportion of subjects with stabilized or improved clinical status at Day 7 on at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Stabilization or Improvement in Clinical Status

Time: 7 days

Description: Change from Baseline (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis). Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Descriptive Clinical Status Analysis

Time: 7 days

Secondary Outcomes

Description: Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure) Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Clinical Status Assessment

Time: 14 days

Description: Time to death

Measure: Time to death

Time: Up to 33 days

Description: Proportion of subjects requiring invasive mechanical ventilation by Day 33.

Measure: Mechanical Ventilation Initiation

Time: Up to 33 days

Description: Duration of invasive mechanical ventilation

Measure: Mechanical Ventilation Duration

Time: Up to 33 days

Description: Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.

Measure: SARS-CoV-2 Test Result

Time: 7 days

Description: Incidence of all AEs

Measure: Incidence of all AEs

Time: Up to 33 days

Description: Incidence of AEs considered related to the IMP

Measure: Incidence of AEs considered related to the IMP

Time: Up to 33 days

Description: Incidence of serious adverse events (SAEs)

Measure: Incidence of serious adverse events (SAEs)

Time: Up to 33 days

Description: Radiological findings (chest CT/chest X-ray)

Measure: Radiological findings (chest CT/chest X-ray)

Time: Up to 7 days

Description: Change from baseline in blood glucose

Measure: Blood glucose

Time: Up to 33 daya

Description: Change from baseline in blood calcium

Measure: Blood calcium

Time: Up to 33 days

Description: Change from baseline in sodium

Measure: Sodium

Time: Up to 33 days

Description: Change from baseline in potassium

Measure: Potassium

Time: Up to 33 days

Description: Change from baseline in carbon dioxide

Measure: Carbon dioxide

Time: Up to 33 days

Description: Change from baseline in chloride

Measure: Chloride

Time: Up to 33 days

Description: Change from baseline in albumin

Measure: Albumin

Time: Up to 33 days

Description: Change from baseline in total protein

Measure: Total protein

Time: Up to 33 days

Description: Change from baseline in alkaline phosphatase

Measure: Alkaline phosphatase

Time: Up to 33 days

Description: Change from baseline in alanine transaminase

Measure: Alanine transaminase

Time: Up to 33 days

Description: Change from baseline in aspartate aminotransferase

Measure: Aspartate aminotransferase

Time: Up to 33 days

Description: Change from baseline in bilirubin

Measure: Bilirubin

Time: Up to 33 days

Description: Change from baseline in blood urea nitrogen

Measure: Blood urea nitrogen

Time: Up to 33 days

Description: Change from baseline in D-dimer

Measure: D-dimer

Time: Up to 33 days

Description: Change from baseline in fibrinogen

Measure: Fibrinogen

Time: Up to 33 days

Description: Change from baseline in PT

Measure: PT

Time: Up to 33 days

Description: Change from baseline in PTT

Measure: PTT

Time: Up to 33 days

Description: Change from baseline in INR

Measure: INR

Time: Up to 33 days

Description: Change from baseline in hsCRP

Measure: hsCRP

Time: Up to 33 days

Description: Change from baseline in ferritin

Measure: Ferritin

Time: Up to 33 days

Description: Change from baseline in LDH

Measure: LDH

Time: Up to 33 days

Description: Change from baseline in IgG

Measure: IgG

Time: Up to 33 days

Description: Change from baseline in IgM

Measure: IgM

Time: Up to 33 days

Description: Change from baseline in IgA

Measure: IgA

Time: Up to 33 days

Description: Change from baseline in IFE

Measure: IFE

Time: Up to 33 days

Description: Change from baseline in troponin

Measure: Troponin

Time: Up to 33 days

Description: Change from baseline in red blood cell count

Measure: Red blood cell count

Time: Up to 33 days

Description: Change from baseline in hemoglobjn

Measure: Hemoglobin

Time: Up to 33 days

Description: Change from baseline in hematocrit

Measure: Hematocrit

Time: Up to 33 days

Description: Change from baseline in mean corpuscular volume

Measure: Mean corpuscular volume

Time: Up to 33 days

Description: Change from baseline in mean corpuscular hemoglobin

Measure: Mean corpuscular hemoglobin

Time: Up to 33 days

Description: Change from baseline in mean corpuscular hemoglobin concentration

Measure: Mean corpuscular hemoglobin concentration

Time: Up to 33 days

Description: Change from baseline in red cell distribution width

Measure: Red cell distribution width

Time: Up to 33 days

Description: Change from baseline in white blood cell count

Measure: White blood cell count

Time: Up to 33 days

Description: Change from baseline in white blood cell differential

Measure: White blood cell differential

Time: Up to 33 days

Description: Change from baseline in platelet count

Measure: Platelet count

Time: Up to 33 days

Description: Change from baseline in mean platelet volume

Measure: Mean platelet volume

Time: Up to 33 days

Description: Change from baseline in platelet distribution width

Measure: Platelet distribution width

Time: Up to 33 days

Description: Change from baseline in SpO2

Measure: SpO2

Time: Up to 33 days

Description: Change from baseline in A-a gradient

Measure: A-a gradient

Time: Up to 33 days

Description: Change from baseline in blood pressure

Measure: Blood Pressure

Time: Up to 33 days

Description: Change from baseline in pulse

Measure: Pulse

Time: Up to 33 days

Description: Change from baseline in respiration rate

Measure: Respiration Rate

Time: Up to 33 days

Description: Change from baseline in body temperature

Measure: Body Temperature

Time: Up to 33 days
12 Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19

The study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study. At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. Following the interim analysis, based on the results, another 800 people are planned to involve.

NCT04426253
Conditions
  1. COVID-19
  2. Sars-CoV2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Disease Progression

Primary Outcomes

Description: Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants

Measure: Identification of genetic factors determining the course of the disease in case of COVID-19

Time: 2020. December
13 Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease

The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.

NCT04429867
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo
MeSH:Disease Progression

Primary Outcomes

Description: The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.

Measure: Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.

Time: 30 Days

Secondary Outcomes

Measure: Hospital length of stay

Time: 30 Days

Measure: 30-Day Mortality

Time: 30 Days

Description: Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.

Measure: Resolution of Symptoms

Time: 14 Days

Measure: Incidence of QTc >500ms after initiation of therapy

Time: 30 Days

Measure: Incidence of discontinuation of therapy

Time: 30 Days
14 A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19

This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.

NCT04446377
Conditions
  1. COVID-19 Disease
Interventions
  1. Drug: Apilimod Dimesylate Capsule
  2. Other: Placebo
MeSH:Disease Progression

Primary Outcomes

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 4

Measure: Viral Load Change

Time: 4 Days

Secondary Outcomes

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 6, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 6 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 8, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 8 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 11, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 11 Days

Description: To evaluate the antiviral efficacy of LAM-002A in participants with COVID-19 as the change from baseline (Day 1, pre-dose) of SARS-CoV-2 viral load as measured by qRT-PCR from nasopharyngeal samples on day 28, compared between the LAM-002A arm and the placebo arm.

Measure: Viral Load Change

Time: 28 Days

Description: To evaluate the anti-viral efficacy of LAM-002A in participants with COVID-19 as difference in SARS-Cov-2 viral load as measured by qRT-PCR from nasopharyngeal samples based on AUC (days1-28), between LAM-002A arm and placebo arm.

Measure: Viral Load AUC

Time: 28 Days

Description: The proportion of LAM-002A treated patients who develop treatment-emergent adverse events (TEAEs) compared to placebo. TEAEs will be defined as AEs that occur on or after the date and time of study drug administration, or those that first occur pre-dose but worsen in frequency or severity after study drug administration. AEs will be followed up until complete resolution or until the Principal Investigator (PI) or Sub-Investigator deems it safe to discontinue followup.

Measure: Safety and Tolerability measured in proportion of TEAEs

Time: 28 Days

Other Outcomes

Description: To evaluate the efficacy of LAM-002A in preventing COVID-19 disease progression in participants who have proven infection with SARS-CoV-2 virus as determined by a molecular test and who have mild manifestations of COVID-19 and less than or equal to 4 days of symptoms; disease progression is defined as occurance of death or hospitalization at day 28.

Measure: Clinical Efficacy in prevention of hospitalization or death

Time: 28 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 1 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 4 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 6 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen Saturation

Time: 8 Days

Description: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.

Measure: Oxygen saturation

Time: 11 Days

Description: Change in COVID-19 clinical status as defined by the ordinal scale, of participants treated with LAM-002A as compared with placebo at Day 28, in participants who become hospitalized and continue LAM-002A/placebo treatment, based on the following scores: Not in the hospital Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula) Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU) Hospitalized, in the ICU, on invasive ventilation or ECMO Dead For participants (who have the same ordinal score), control versus experimental arms will be compared based on percentage of participants at each score.

Measure: Clinical Status defined by ordinal scale

Time: 28 days
15 A Randomised Phase II/III Trial in a Community Setting, Assessing Use of Camostat in Reducing the Clinical Progression of COVID-19 by Blocking SARS-CoV-2 Spike Protein-initiated Membrane Fusion

This is a phase II/III randomised, multi-centre, prospective, open label, community-based clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who have mild disease and therefore can treat their symptoms in the community. Patients who seek testing and have a confirmed positive test result will be invited to enrol in the trial.

NCT04455815
Conditions
  1. COVID-19 Infection
Interventions
  1. Drug: Camostat
MeSH:Disease Progression

Primary Outcomes

Measure: Number of participants who require hospital admission and require supplemental oxygen.

Time: Days 1-28

Secondary Outcomes

Measure: Rate of COVID-19 related hospital admission in patients with SARS-CoV-2 infection.

Time: Days 1-28 from randomisation.

Measure: Number of supplementary oxygen-free days at 28 days (from randomisation).

Time: Days 1-28 from randomisation.

Measure: Number of ventilator-free days at 28 days (from randomisation).

Time: Days 1-28 from randomisation.

Measure: To evaluate overall mortality.

Time: one year from randomisation.

Measure: Time to worst point on the scale or deterioration of two points or more (from randomisation) on a 9-point category ordinal scale.

Time: Days 1-28.
16 Predictors of COVID-19 Infection and Disease Progression

Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19

NCT04484597
Conditions
  1. Positive COVID-19 by PCR
Interventions
  1. Diagnostic Test: Rt PCR
MeSH:Disease Progression

Primary Outcomes

Description: Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM & IgG and the severity of the clinical picture

Measure: correlation of COVID-19 antibody to PCR

Time: 1 year

Secondary Outcomes

Description: Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture

Measure: correlation of ancillaey tests to PCR

Time: 1 year
17 Clearing the Fog: Is HCQ Effective in Reducing COVID-19 progression-a Randomized Controlled Trial

Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance. Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III

NCT04491994
Conditions
  1. Covid19
  2. Progression
Interventions
  1. Drug: HCQ
MeSH:Disease Progression

Primary Outcomes

Description: After start of treatment, development of fever > 101 F for > 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC < 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status

Measure: Number of Participants With Progression

Time: 5 days

Secondary Outcomes

Description: PCR negativity on day 7 and 14 after admission

Measure: Viral Clearance

Time: 14 days
18 Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19

Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.

NCT04534712
Conditions
  1. Covid19
Interventions
  1. Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO
MeSH:Disease Progression

Primary Outcomes

Description: disease progression equal or more than 2 stages

Measure: progression

Time: 28 days

Secondary Outcomes

Description: end outcome of the patients diagnosed of COVID-19 infection

Measure: mortality

Time: 28 days

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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