Covid 19 Research using Clinical Trials (Home Page)
Report for D018450: Disease Progression NIH
(Synonyms: Disease Progression)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (25)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2661 | Vitamin B12 Wiki | 0.26 |
| drug10 | 0.9% sodium chloride (normal saline) Wiki | 0.26 |
| drug2695 | Whole Genome Analysis Wiki | 0.26 |
| drug1675 | Octagam 10% Wiki | 0.26 |
| drug294 | BIOVITALS Wiki | 0.26 |
| drug2717 | Zinc Citrate Wiki | 0.26 |
| drug2406 | T-cell receptor (TCR) repertoire Wiki | 0.26 |
| drug2141 | SARS-CoV-2 viral composition Wiki | 0.26 |
| drug2489 | The control group will not receive hydroxychloroquine Wiki | 0.26 |
| drug1995 | RBT-9 (90 mg) Wiki | 0.26 |
| drug511 | Camostat Wiki | 0.26 |
| drug201 | Apilimod Dimesylate Capsule Wiki | 0.26 |
| drug2765 | blood sample Wiki | 0.21 |
| drug2068 | Remdesivir placebo Wiki | 0.18 |
| drug1751 | PUL-042 Inhalation Solution Wiki | 0.18 |
| drug2787 | convalescent plasma Wiki | 0.13 |
| drug2664 | Vitamin D3 Wiki | 0.13 |
| drug454 | COVID-19 Convalescent Plasma Wiki | 0.12 |
| drug1484 | Methylprednisolone Wiki | 0.08 |
| drug2662 | Vitamin C Wiki | 0.08 |
| drug1086 | Hydroxychloroquine Wiki | 0.08 |
| drug2067 | Remdesivir Wiki | 0.07 |
| drug1822 | Placebo Wiki | 0.06 |
| drug2527 | Tocilizumab Wiki | 0.05 |
| drug262 | Azithromycin Wiki | 0.04 |
Correlated MeSH Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007239 | Infection NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 15 clinical trials
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 COVID-19 Drug: PUL-042 Inhalation Solution 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 daysSecondary 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 daysDescription: 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 daysDescription: 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 daysDescription: The requirement for ICU admission within 28 days from the start of experimental therapy.
Measure: ICU admission Time: 28 daysDescription: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.
Measure: Mechanical ventilation Time: 28 daysDescription: All cause mortality at 28 days from the start of experimental therapy.
Measure: Mortality Time: 28 days2 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 COVID-19 Drug: Hydroxychloroquine 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 days3 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 COVID19 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 daysSecondary Outcomes
Description: Adherence to device
Measure: Compliance to complete the study Time: within 14 daysDescription: To identify COVID19 subjects
Measure: Sensitivity and specificity of Biovitals® Sentinel Time: within 14 daysDescription: % of family members infection
Measure: Cross infection rate within the family cluster Time: within 14 daysDescription: Length of hospital stay
Measure: Length of hospital stay of positive subjects Time: 1 year at study completionDescription: Length of ICU stay
Measure: Length of ICU stay of positive patients Time: 1 year at study completionDescription: Vital signs of positive patients
Measure: National Early Warning Score 2 rating of positive patients Time: 4 weeks from diagnosisDescription: Virology laboratory result of nasopharyngeal swab
Measure: Viral load of positive patients Time: 4 weeks from diagnosisDescription: Worsening of comorbidities
Measure: Worsening of comorbidities Time: 1 year at study completionDescription: Mortality
Measure: Mortality Time: 1 year at study completion4 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 COVID-19 Drug: Tocilizumab Drug: Methylprednisolone MeSH:Disease Progression
Primary Outcomes
Measure: The proportion of patients requiring mechanical ventilation Time: Through study completion, and average of 6 monthsMeasure: 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 monthsMeasure: 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 COVID-19 Drug: RBT-9 (90 mg) 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 daysSecondary 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 DaysDescription: Percentage of subjects who are alive at Day 28
Measure: All-cause survival Time: 28 DaysDescription: 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 DaysDescription: Percentage of subjects with fever through Day 28
Measure: Fever incidence Time: 28 DaysDescription: 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 DaysDescription: Percentage of subjects with new or worsening congestive HF through Day 28
Measure: New or worsening congestive heart failure (HF) Time: 28 DaysDescription: Percentage of subjects who remain hospitalized at Day 28
Measure: Hospitalization status Time: 28 DaysDescription: 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 DaysDescription: Number of oxygen-free days through Day 28
Measure: Oxygen-free days Time: 28 DaysDescription: Percentage of subjects transferred to the ICU through Day 28
Measure: Intensive care unit (ICU) status Time: 28 DaysDescription: Number of days on mechanical ventilation through Day 28
Measure: Days on ventilator Time: 28 DaysDescription: Time to and duration of vasopressor or inotrope utilization through Day 28
Measure: Time to and duration of vasopressor or inotrope utilization Time: 28 DaysDescription: Percentage of subjects who begin dialysis through Day 28
Measure: Dialysis status Time: 28 Days6 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 COVID-19 Genetic: Whole Genome Analysis Genetic: T-cell receptor (TCR) repertoire 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 recoverySecondary 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 recoveryDescription: 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 recovery7 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 Kidney Transplant; Complications Coronavirus Infection 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 months8 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 COVID-19 by SARS-CoV-2 Infection 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 months9 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 Coronavirus Disease 2019 )COVID-19) 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 COVID19 Dietary Supplement: Vitamin C Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Zinc Citrate Dietary Supplement: Vitamin D3 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 hospitalDescription: total number of days in hospital since admission
Measure: Length of hospital stay Time: at 15 and 45 days since admission/ enrolmentDescription: 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 enrolmentSecondary Outcomes
Description: Death
Measure: Mortality Time: 15 and 45 days since enrolmentDescription: 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 enrolmentDescription: need for and number of days for humidified high-flow oxygen
Measure: oxygen Time: 15 and 45 days since enrolmentDescription: admission to ICU (intensive care unit)
Measure: ICU Time: 15 and 45 days since enrolmentDescription: days in hospital
Measure: days in hospital Time: 15 and 45 days since enrolmentDescription: days in ICU
Measure: days in ICU Time: 15 and 45 days since enrolmentDescription: need for and days of renal replacement therapy
Measure: renal replacement therapy Time: 15 and 45 days since enrolmentDescription: need for and days of Extracorporeal support
Measure: Extracorporeal support Time: 15 and 45 days since enrolment11 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 Covid-19 Biological: Octagam 10% 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 daysDescription: 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 daysSecondary 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 daysDescription: Time to death
Measure: Time to death Time: Up to 33 daysDescription: Proportion of subjects requiring invasive mechanical ventilation by Day 33.
Measure: Mechanical Ventilation Initiation Time: Up to 33 daysDescription: Duration of invasive mechanical ventilation
Measure: Mechanical Ventilation Duration Time: Up to 33 daysDescription: 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 daysDescription: Incidence of all AEs
Measure: Incidence of all AEs Time: Up to 33 daysDescription: Incidence of AEs considered related to the IMP
Measure: Incidence of AEs considered related to the IMP Time: Up to 33 daysDescription: Incidence of serious adverse events (SAEs)
Measure: Incidence of serious adverse events (SAEs) Time: Up to 33 daysDescription: Radiological findings (chest CT/chest X-ray)
Measure: Radiological findings (chest CT/chest X-ray) Time: Up to 7 daysDescription: Change from baseline in blood glucose
Measure: Blood glucose Time: Up to 33 dayaDescription: Change from baseline in blood calcium
Measure: Blood calcium Time: Up to 33 daysDescription: Change from baseline in sodium
Measure: Sodium Time: Up to 33 daysDescription: Change from baseline in potassium
Measure: Potassium Time: Up to 33 daysDescription: Change from baseline in carbon dioxide
Measure: Carbon dioxide Time: Up to 33 daysDescription: Change from baseline in chloride
Measure: Chloride Time: Up to 33 daysDescription: Change from baseline in albumin
Measure: Albumin Time: Up to 33 daysDescription: Change from baseline in total protein
Measure: Total protein Time: Up to 33 daysDescription: Change from baseline in alkaline phosphatase
Measure: Alkaline phosphatase Time: Up to 33 daysDescription: Change from baseline in alanine transaminase
Measure: Alanine transaminase Time: Up to 33 daysDescription: Change from baseline in aspartate aminotransferase
Measure: Aspartate aminotransferase Time: Up to 33 daysDescription: Change from baseline in bilirubin
Measure: Bilirubin Time: Up to 33 daysDescription: Change from baseline in blood urea nitrogen
Measure: Blood urea nitrogen Time: Up to 33 daysDescription: Change from baseline in D-dimer
Measure: D-dimer Time: Up to 33 daysDescription: Change from baseline in fibrinogen
Measure: Fibrinogen Time: Up to 33 daysDescription: Change from baseline in PT
Measure: PT Time: Up to 33 daysDescription: Change from baseline in PTT
Measure: PTT Time: Up to 33 daysDescription: Change from baseline in INR
Measure: INR Time: Up to 33 daysDescription: Change from baseline in hsCRP
Measure: hsCRP Time: Up to 33 daysDescription: Change from baseline in ferritin
Measure: Ferritin Time: Up to 33 daysDescription: Change from baseline in LDH
Measure: LDH Time: Up to 33 daysDescription: Change from baseline in IgG
Measure: IgG Time: Up to 33 daysDescription: Change from baseline in IgM
Measure: IgM Time: Up to 33 daysDescription: Change from baseline in IgA
Measure: IgA Time: Up to 33 daysDescription: Change from baseline in IFE
Measure: IFE Time: Up to 33 daysDescription: Change from baseline in troponin
Measure: Troponin Time: Up to 33 daysDescription: Change from baseline in red blood cell count
Measure: Red blood cell count Time: Up to 33 daysDescription: Change from baseline in hemoglobjn
Measure: Hemoglobin Time: Up to 33 daysDescription: Change from baseline in hematocrit
Measure: Hematocrit Time: Up to 33 daysDescription: Change from baseline in mean corpuscular volume
Measure: Mean corpuscular volume Time: Up to 33 daysDescription: Change from baseline in mean corpuscular hemoglobin
Measure: Mean corpuscular hemoglobin Time: Up to 33 daysDescription: Change from baseline in mean corpuscular hemoglobin concentration
Measure: Mean corpuscular hemoglobin concentration Time: Up to 33 daysDescription: Change from baseline in red cell distribution width
Measure: Red cell distribution width Time: Up to 33 daysDescription: Change from baseline in white blood cell count
Measure: White blood cell count Time: Up to 33 daysDescription: Change from baseline in white blood cell differential
Measure: White blood cell differential Time: Up to 33 daysDescription: Change from baseline in platelet count
Measure: Platelet count Time: Up to 33 daysDescription: Change from baseline in mean platelet volume
Measure: Mean platelet volume Time: Up to 33 daysDescription: Change from baseline in platelet distribution width
Measure: Platelet distribution width Time: Up to 33 daysDescription: Change from baseline in SpO2
Measure: SpO2 Time: Up to 33 daysDescription: Change from baseline in A-a gradient
Measure: A-a gradient Time: Up to 33 daysDescription: Change from baseline in blood pressure
Measure: Blood Pressure Time: Up to 33 daysDescription: Change from baseline in pulse
Measure: Pulse Time: Up to 33 daysDescription: Change from baseline in respiration rate
Measure: Respiration Rate Time: Up to 33 daysDescription: Change from baseline in body temperature
Measure: Body Temperature Time: Up to 33 days12 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 COVID-19 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. December13 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 COVID-19 Drug: Hydroxychloroquine 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 DaysSecondary Outcomes
Measure: Hospital length of stay Time: 30 DaysMeasure: 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 DaysMeasure: 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 COVID-19 Disease Drug: Apilimod Dimesylate Capsule 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 DaysSecondary 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 DaysDescription: 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 DaysDescription: 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 DaysDescription: 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 DaysDescription: 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 DaysDescription: 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 DaysOther 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 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.
Measure: Oxygen Saturation Time: 1 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.
Measure: Oxygen Saturation Time: 4 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.
Measure: Oxygen Saturation Time: 6 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.
Measure: Oxygen Saturation Time: 8 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo.
Measure: Oxygen saturation Time: 11 DaysDescription: 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 days15 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 COVID-19 Infection Drug: Camostat MeSH:Disease Progression
Primary Outcomes
Measure: Number of participants who require hospital admission and require supplemental oxygen. Time: Days 1-28Secondary 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.