Name (Synonyms) | Correlation | |
---|---|---|
drug1162 | IW-3718 Wiki | 0.38 |
drug1322 | Lactoferrin Wiki | 0.27 |
drug2430 | TJ003234 Wiki | 0.27 |
drug214 | Artemisinin / Artesunate Wiki | 0.27 |
drug1028 | HFNO Wiki | 0.27 |
drug2883 | mechanical ventilation Wiki | 0.27 |
drug308 | BVRS-GamVac Wiki | 0.27 |
drug3025 | thalidomide Wiki | 0.27 |
drug3049 | washed microbiota transplantation Wiki | 0.27 |
drug2791 | conventional oxygen Wiki | 0.27 |
drug2375 | Sulfonatoporphyrin(TPPS) plus Sunlight exposure. Wiki | 0.27 |
drug2908 | nangibotide Wiki | 0.27 |
drug2741 | anti-SARS-CoV-2 plasma Wiki | 0.27 |
drug2857 | intradermal injection of BCG Vaccine Wiki | 0.27 |
drug2822 | fezolinetant Wiki | 0.27 |
drug1320 | Lactobaciltus rhamnosus GG Wiki | 0.27 |
drug309 | BVRS-GamVac-Combi Wiki | 0.27 |
drug492 | CPAP Wiki | 0.27 |
drug1321 | Lactobaciltus rhamnosus GG Placebo Wiki | 0.27 |
drug1652 | Novel laser inferometry test for CORONA virus Wiki | 0.27 |
drug2482 | Thalidomide Wiki | 0.27 |
drug751 | Dexamethasone injection Wiki | 0.19 |
drug1783 | Peginterferon Lambda-1A Wiki | 0.19 |
drug2276 | SnPP Protoporphyrin plus Sunlight exposure Wiki | 0.15 |
drug1355 | Lopinavir / Ritonavir Wiki | 0.13 |
drug923 | Favipiravir Wiki | 0.06 |
drug1822 | Placebo Wiki | 0.03 |
drug1086 | Hydroxychloroquine Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D004942 | Esophagitis, Peptic NIH | 0.38 |
D005764 | Gastroesophageal Reflux NIH | 0.31 |
D019584 | Hot Flashes NIH | 0.27 |
D018352 | Coronavirus Infections NIH | 0.07 |
D013577 | Syndrome NIH | 0.06 |
D007249 | Inflammation NIH | 0.05 |
D011014 | Pneumonia NIH | 0.03 |
D003141 | Communicable Diseases NIH | 0.02 |
D007239 | Infection NIH | 0.02 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002020 | Gastroesophageal reflux HPO | 0.31 |
HP:0002090 | Pneumonia HPO | 0.03 |
There are 14 clinical trials
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standarddose proton pump inhibitors (PPIs).
This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks. This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo). At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
Description: An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
Measure: Frequency of Adverse Events (AE) Time: Up to 55 weeksDescription: An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
Measure: Severity of Adverse Events Time: Up to 55 weeksDescription: Endometrial hyperplasia is thickening of the lining of the uterus. Endometrial cancer is cancer of the lining of the uterus. Percentage of participants will be reported.
Measure: Percentage of participants with endometrial hyperplasia and/or endometrial cancer Time: Up to 52 weeksDescription: Endometrial thickness is a measure of how thick the lining of the uterus is. Change from baseline will be reported.
Measure: Change from baseline in endometrial thickness Time: Baseline and 52 weeksDescription: Bone density is the amount of bone mineral in bone tissue. The change from baseline will be reported.
Measure: Change from baseline in bone mass density (BMD) at hip Time: Baseline and 52 weeksDescription: The trabecular bone score is a measure of bone texture correlated with bone microarchitecture. High TBS value means that microarchitecture bone is dense, well connected with little spaces between trabeculaes. Low TBS value means that the microarchitecture of bone is incomplete and poorly connected with wide spaces between trabeculae. Change from baseline will be reported.
Measure: Change from baseline in trabecular bone score (TBS) at hip Time: Baseline and 52 weeksDescription: Bone density is the amount of bone mineral in bone tissue. Change from baseline will be reported.
Measure: Change from baseline in bone mass density (BMD) at spine Time: Baseline and 52 weeksDescription: The trabecular bone score is a measure of bone texture correlated with bone microarchitecture. High TBS value means that microarchitecture bone is dense, well connected with little spaces between trabeculaes. Low TBS value means that the microarchitecture of bone is incomplete and poorly connected with wide spaces between trabeculae. Change from baseline will be reported.
Measure: Change from baseline in trabecular bone score (TBS) at spine Time: Baseline and 52 weeksDescription: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs) Time: Up to 55 weeksDescription: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to 55 weeksDescription: Number of participants with potentially clinically significant ECG values.
Measure: Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs) Time: Up to 52 weeksDescription: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.
Measure: Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Time: Up to 55 weeksThe Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants With Serious Adverse Events
Measure: Number of Participants With Serious Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measure: Number of Participants with Solicited Local and Systemic Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA) Time: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90Description: determination of specific T-cell- mediated response vs. baseline values and placebo
Measure: Assessment of antigen-specific cell-mediated immune response Time: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Measure: Neutralizing antibody levels Time: at days 0, 14 and 28 from the start of vaccination compared to baseline valuesThe Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.
Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants With Serious Adverse Events
Measure: Number of Participants With Serious Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measure: Number of Participants with Solicited Local and Systemic Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA) Time: at days 0, 7, 14, 21, 28, 42, 56 and 90Description: determination of specific T-cell- mediated response vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Assessment of antigen-specific cell-mediated immune response Time: at 0 and 14 days from the start of vaccination compared to baseline values (day 0)Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values
Measure: Neutralizing antibody levels Time: at days 0, 14 and 28Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.
Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.
Measure: Number of participants with improvement from severe type to common type Time: 2 weeksIn December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 daysDescription: baseline SpO2 during screening, PaO2/FiO2 <300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Measure: All cause mortality Time: up to 28 daysDescription: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measure: Frequency of respiratory progression Time: up to 28 daysDescription: in those with fever at enrolment
Measure: Time to defervescence Time: up to 28 daysDescription: in those with cough at enrolment rated severe or moderate
Measure: Time to cough reported as mild or absent Time: up to 28 daysDescription: patients with moderate / severe dyspnea when enrolled
Measure: Respiratory improvement time Time: up to 28 daysIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.
Description: TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Measure: Time to Clinical Improvement (TTCI) Time: up to 28 daysDescription: Clinical status, assessed by the ordinal scale at fixed time points
Measure: Clinical status Time: days 7, 14, 21, and 28The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
Description: The time-to-death from all causes within the first 60 days after randomization.
Measure: The time-to-death from all causes Time: day-60Description: the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
Measure: The time to need for mechanical ventilation (MV) Time: day-28.Description: The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
Measure: The viral load in the respiratory tract Time: day-10Description: Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
Measure: Number of patient with at least one episode of healthcare-associated infections Time: day-28Description: To compare the exposition to mechanical ventilation
Measure: Number of days alive without mechanical ventilation Time: day-28Description: Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)
Measure: Measure of SOFA score Time: day-28Description: to compare the exposition to renal replacement therapy
Measure: Number of days alive without renal replacement therapy Time: day-28Description: To compare the lengths of ICU
Measure: Lengths of ICU-stay Time: day-60Description: To compare the lengths of hospital-stay
Measure: Lengths of hospital-stay Time: day-60Description: Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
Measure: Number of patients with severe hypoxemia, Time: day 60Description: Proportion of patients with cardiac arrest within 1 hour after intubation
Measure: Number of patients with cardiac arrest within 1 hour after intubation Time: day 60Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
Description: Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
Measure: incidence of confirmed COVID-19 Time: 9 monthsDescription: Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers
Measure: Effectiveness of BCG vaccine Time: 9 monthsInterferon lambda is one of the main arms of the innate antiviral immune response and is critical for controlling respiratory viral infections in mice. Interferon lambda has a better side effect profile than other interferons because of the limited tissue distribution of its receptor. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming its safety. We propose to evaluate peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.
Description: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
Measure: Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint) Time: At day 7Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Measure: Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint) Time: Day 0 to Day 30Description: Time to SARS-CoV-2 RNA negativity.
Measure: Cohort B (Hospitalized) - Time to viral negativity (Primary Efficacy Endpoint) Time: Day 0 to day 28Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Measure: Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint) Time: Day 0 to Day 30Description: Time to resolution of symptoms (fever, cough, diarrhea)
Measure: Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1) Time: Day 0 to Day 14Description: Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better
Measure: Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2) Time: Day 0 to Day 7Description: Proportion with need for hospital admission
Measure: Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3) Time: Day 0 to Day 14Description: Adverse events and serious adverse events
Measure: Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4) Time: Day 0 to Day 14Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab
Measure: Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1) Time: At Day 3Description: Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva
Measure: Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2) Time: Day 0 to Day 14Description: Proportion with SARS-CoV-2 RNA in blood.
Measure: Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3) Time: Day 0 and Day 7Description: Proportion with SARS-CoV-2 antibodies blood
Measure: Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4) Time: Day 0 and Day 7Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
Measure: Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5) Time: Through day 7Description: Proportion with symptom development in household contacts (categorical symptom type yes/no)
Measure: Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1) Time: Day 0 to Day 14Description: Proportion with confirmed diagnosis of COVID-19 in household contacts
Measure: Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2) Time: At Day 30Description: Proportion with ICU admission during hospitalization
Measure: Cohort B (Hospitalized) - ICU admission (Clinical Outcome #1) Time: Day 0 to day 30Description: Proportion with need for intubation
Measure: Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #2) Time: Day 0 to Day 14Description: Length of hospital stay (days)
Measure: Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #3) Time: Day 0 to Day 14Description: Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)
Measure: Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #4) Time: Day 0 to 7 and Day 0 to 14Description: Proportion with readmission to hospital
Measure: Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #5) Time: By day 30 and Day 90Description: All-cause mortality
Measure: Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6) Time: At day 30 and day 90Description: COVID-19-related mortality
Measure: Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #7) Time: At day 30Description: Adverse (AEs) and Serious Adverse Events (SAEs)
Measure: Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #8) Time: Day 0 to day 30Description: Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
Measure: Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #9) Time: Day 7 to day 11Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab.
Measure: Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #1) Time: Day 7Description: Proportion negative for SARS-CoV-2 by nasopharyngeal swab
Measure: Cohort B (Hospitalized) - Proportion negative by day 14 (Virologic/Immunological Outcome) #2) Time: Day 14Description: Time to SARS-CoV-2 RNA negativity by rectal swab
Measure: Cohort B (Hospitalized) - Time to negativity by rectal swab (Virologic/Immunological Outcome #3) Time: Day 0 to day 14Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
Measure: Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4) Time: Through Day 14Description: Proportion with SARS-CoV-2 Antibody.
Measure: Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological Outcome #6) Time: At Day 7 and Day 14Description: Proportion with SARS-CoV-2 RNA in blood
Measure: Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #7) Time: Day 0, Day 7, and Day 14Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients (SnPPIX) Mahmoud ELkazzaz(1),Rokia yousry abdelaziz sallam(2) _____________________________________________________________________________________________ _________________________________________________________________________ Abstract : The novel coronavirus pneumonia (COVID-19) is an infectious acute respiratory caused by the novel coronavirus. The virus is a positive-strand RNA virus with high homology to bat coronavirus. Depending on published study in which , conserved domain analysis, homology modeling, and molecular docking were used to compare the biological roles of specific proteins of the novel coronavirus. The principal investigator demonstrated according to previous researches that some viral structural and nonstructural proteins could bind to the porphyrin, respectively. At the same time, orf1ab, ORF10 and ORF3a proteins coordinated to attack heme on the 1-beta chain of hemoglobin, COVID-19 binds to the porphyrin of haem and displaces iron and a study denonestrated that Covid-19 could cause acquired acute porphyria which is the condition in which there is excess accumulation of porphyrin intermediate metabolites. This point can be taken advantage of X-ray induced visible luminescence of porphyrin for producing of Reactive Oxygen Species (ROS).Many porphyrins are benign in the dark but are transformed by sunlight into caustic, flesh-eating toxins Porphyrins have been used for photodynamic therapy (PDT) against a wide range of targets like bacteria, viruses and tumor cells It has been reported that ROS-based inactivation of viruses may occur due to several reasons, such as protein oxidation, single strand breaks in the RNA genome and protein-RNA crosslinking. Since ROS-based inactivation has a multi-targeted mechanism, it is much less likely that a virus would be able to develop resistance against it. Recently, porphyrins, already in use as photosensitizers for Photodynamic Therapy (PDT), were a study target to applications in medical area, namely as possible contrast agents in MRI. could be observed some examples of porphyrin derivatives already study as MRI contrast media. Low dark toxicity, neoplastic tissue affinity and synthetic accessibility are some of the important properties that contribute for its selection. In MRI studies was found that CM based on paramagnetic metalloporphyrins showed higher affinity for neoplastic tissues, observed by increased relaxation time of the neoplastic tissues, which is reflected on an increase in MRI signal and consequently in a better neoplastic lesions detection. A study demonestrated that The sulfonated tetranaphthyl porphyrin contrast agents in MRI (TNapPS), sulfonated tetra-anthracenyl porphyrin (TAnthPS), and sulfonated 2,6-difluoro-meso-tetraphenylporphine [TPP(2,6-F2)S] and its copper chelate [TPP(2,6-F2)S,Cu], which reduced HIV infection by 99, 96, 94, and 96%, respectively. Previous studies which showed that Covid -19 binds to the porphyrin of haem and displaces iron in addition to Sulfonated porphyrins and light-stimulated Sn- protoporphyrin IX have broad antiviral activity against more distinct types of viruses, Co-protoporphyrin IX and Sn-protoporphyrin IX inactivate Zika, Chikungunya and other arboviruses by targeting the viral envelope Porphyrins are amphipathic molecules able to interact with membranes and absorb light, being widely used in photodynamic therapy. Previously, we showed that heme, Co-protoporphyrin IX (CoPPIX) and Sn-protoporphyrin IX (SnPPIX) directly inactivate DENV and YFV infectious particles. Here we demonstrate that the antiviral activity of these porphyrins can be broadened to CHIKV, ZIKV, Mayaro virus, Sindb is virus and Vesicular Stomatitis virus. Porphyrin treatment causes viral envelope protein loss, affecting viral morphology, adsorption and entry into target cells , Finally, the principal investigator expect that viral load will be declined with sunlight because In particular, porphyrins absorb essentially all the UV/visible light wavelengths in the emission spectrum of the sun; hence they are active at very low doses . Keywords: COVID 2019 ,Infection, Sulfonated porphyrins and X-ray induced visible luminescence of porphyrin
Description: Proportion of lung injury score decreased or increased after treatment
Measure: lung injury score Time: at 7and 14 daysDescription: Serum ferritin
Measure: Serum ferritin Time: at day 1-3-7 and 14Description: lymphocyte counts
Measure: Absolute lymphocyte counts Time: at day 7 and 14Description: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon
Measure: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon Time: at day 7 and 14Description: Serum level of COVID19 RNA
Measure: Serum level of COVID19 RNA Time: at day 7 and 14Description: died
Measure: All cause mortality rate Time: at day 7 and 14Description: ventilation free days
Measure: Ventilation free days Time: at 14 daysDescription: ICU free days
Measure: ICU free days Time: at 14 daysDescription: less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Measure: d-dimers Time: at 3-5daysDescription: (if pos. at baseline)
Measure: Time to first negative SARS-CoV-2 PCR in NP swap Time: within 14 daysCoronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
Description: absence of the virus shedding evidenced by negative swabs
Measure: length of stay in hospital Time: within the first 6 days interventionDescription: reduction of morbidity and mortality
Measure: number of ICU admission Time: 14 daysDescription: finding the time that the symptoms disappear
Measure: resolution of symptoms Time: 6 days - 10 dayThis 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.
Description: Incidence of adverse events until day 28
Measure: Adverse Events Time: 28 daysDescription: Incidence of mortality until day 28
Measure: Mortality Time: 28 days