Name (Synonyms) | Correlation | |
---|---|---|
drug1638 | pregnant women with laboratory-confirmed 2019-n-CoV Wiki | 0.18 |
drug626 | Hydroxychloroquine as post exposure prophylaxis Wiki | 0.13 |
drug279 | Cambridge Validated Viral Detection Method Wiki | 0.13 |
drug996 | Peginterferon Lambda-1a Wiki | 0.13 |
drug901 | No intervention (survey study for medical doctors). Wiki | 0.13 |
drug672 | Indomethacin Wiki | 0.13 |
drug1400 | To assess for development of IgG antibodies against SARS-CoV2 Wiki | 0.13 |
drug1645 | remdesivir Wiki | 0.13 |
drug1236 | Seraph®-100 Microbind® Affinity Blood Filter Wiki | 0.13 |
drug362 | Convalescent Plasma 1 Unit Wiki | 0.13 |
drug386 | Crest Pro-Health Multi-Protection mouthwash Wiki | 0.13 |
drug658 | IgM and IgG diagnostic kits to SARS-CoV-2 Wiki | 0.13 |
drug655 | Icosapent ethyl Wiki | 0.13 |
drug949 | Oral-B Mouth Sore mouthwash Wiki | 0.13 |
drug1124 | Radiological Detection Wiki | 0.13 |
drug1279 | Standard medical care Wiki | 0.13 |
drug711 | Isotonic saline 0.9% Wiki | 0.13 |
drug666 | Immunological profiling Wiki | 0.13 |
drug511 | Favipiravir Combined With Tocilizumab Wiki | 0.13 |
drug954 | Others(No intervention) Wiki | 0.13 |
drug1375 | Tetrandrine Wiki | 0.13 |
drug1472 | Viral Specific T-cells (VSTs) Wiki | 0.13 |
drug985 | Pathogen-specific aAPC Wiki | 0.13 |
drug1017 | Placebo (PBO) Wiki | 0.13 |
drug286 | Capillary and salivary sampling Wiki | 0.13 |
drug483 | Ergoferon Wiki | 0.13 |
drug620 | Hydroxychloroquine Sulfate Tablets Wiki | 0.13 |
drug632 | Hydroxychloroquine sulfate &Azithromycin Wiki | 0.13 |
drug1525 | biological samples collection Wiki | 0.13 |
drug1181 | SARS-CoV-2 Wiki | 0.13 |
drug727 | Kevzara sc Wiki | 0.13 |
drug1120 | RT-PCR Covid-19 Wiki | 0.13 |
drug1127 | Ranitidine Wiki | 0.13 |
drug330 | CloSYS mouthwash Wiki | 0.13 |
drug862 | NO intervention planned due to the observational study design only a diagnostic testing Wiki | 0.13 |
drug1393 | Thrombin Generation Assay (TGA) Wiki | 0.13 |
drug1061 | Povidone-Iodine 0.5% Wiki | 0.13 |
drug1395 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.13 |
drug1677 | trimethoprim/sulfamethoxazole Wiki | 0.13 |
drug248 | COVID-19 IgM/IgG Rapid Testing, mobile device image capture and telemedicine support Wiki | 0.13 |
drug970 | PLACEBO GROUP Wiki | 0.13 |
drug960 | Oxytocin Wiki | 0.13 |
drug1210 | Saline containing 1% Human serum albumin(solution of MSC) Wiki | 0.13 |
drug336 | Colchicine 1 MG Oral Tablet Wiki | 0.13 |
drug723 | KIR phenotype evaluation Wiki | 0.13 |
drug476 | Enoxaparin Prefilled Syringe [Lovenox] Wiki | 0.13 |
drug868 | NaCl Solution Wiki | 0.13 |
drug1346 | TLRs activation measurement Wiki | 0.13 |
drug678 | Inhaled beclomethasone Wiki | 0.13 |
drug133 | Azithromycin 500 milligram (mg) oral Tablet Wiki | 0.13 |
drug758 | Lopinavir/ Ritonavir Oral Tablet Wiki | 0.13 |
drug510 | Favipiravir + Standard of Care Wiki | 0.13 |
drug621 | Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki | 0.13 |
drug23 | 300 mg EIDD-2801 Wiki | 0.13 |
drug1508 | Zithromax Oral Product Wiki | 0.13 |
drug434 | Distilled water Wiki | 0.13 |
drug1614 | nosocomial infection/hospital acquired infection Wiki | 0.13 |
drug1178 | SAMBA II (Diagnostic for the Real World) Wiki | 0.13 |
drug1062 | Povidone-Iodine 2% Wiki | 0.13 |
drug83 | Anluohuaxian Wiki | 0.13 |
drug466 | Elisa-test for IgM and IgG to SARS-CoV-2 Wiki | 0.13 |
drug722 | JNJ-53718678 Wiki | 0.13 |
drug1163 | Risk of MERS infection Wiki | 0.13 |
drug363 | Convalescent Plasma 2 Units Wiki | 0.13 |
drug1168 | RoActemra sc Wiki | 0.13 |
drug320 | Clarithromycin Wiki | 0.13 |
drug1091 | Pulmonary and Motor Rehabilitation Wiki | 0.13 |
drug296 | Cellular response Wiki | 0.13 |
drug770 | Low nitrite/NDMA meals Wiki | 0.13 |
drug576 | High nitrite/NDMA meals Wiki | 0.13 |
drug983 | Partially HLA-matched Virus Specific T cells (VSTs) Wiki | 0.13 |
drug1605 | nasopharyngeal swab Wiki | 0.13 |
drug147 | BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki | 0.13 |
drug1012 | Physiotherapy Wiki | 0.13 |
drug1089 | Public Health England Gold Standard Wiki | 0.13 |
drug856 | NHANES smell and taste tests Wiki | 0.13 |
drug1519 | artus Influenza A/B RT-PCR Test Wiki | 0.13 |
drug1167 | RoActemra iv Wiki | 0.13 |
drug276 | CYNK-001 Wiki | 0.13 |
drug392 | Cytokines measurement Wiki | 0.13 |
drug1328 | Survey and Questionnaire Wiki | 0.13 |
drug202 | Blood plasma Wiki | 0.13 |
drug729 | LAU-7b Wiki | 0.13 |
drug209 | Blood samples (collection of 5 mL of blood in a dry tube) Wiki | 0.13 |
drug143 | BCG GROUP Wiki | 0.13 |
drug1280 | Standard of Care Wiki | 0.12 |
drug505 | Favipiravir Wiki | 0.12 |
drug1016 | Placebo Wiki | 0.11 |
drug73 | Anakinra Wiki | 0.10 |
drug154 | BNT162b1 Wiki | 0.09 |
drug15 | 200 mg EIDD-2801 Wiki | 0.09 |
drug156 | BNT162c2 Wiki | 0.09 |
drug1350 | Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki | 0.09 |
drug785 | MSCs Wiki | 0.09 |
drug465 | Electronic questionnaire Wiki | 0.09 |
drug618 | Hydroxychloroquine Sulfate Loading Dose Wiki | 0.09 |
drug619 | Hydroxychloroquine Sulfate Regular dose Wiki | 0.09 |
drug594 | Hydroxychloroquine + Azithromycin Wiki | 0.09 |
drug145 | BCG vaccine Wiki | 0.09 |
drug153 | BNT162a1 Wiki | 0.09 |
drug155 | BNT162b2 Wiki | 0.09 |
drug591 | Hydroxychloroquine Wiki | 0.08 |
drug1617 | observational Wiki | 0.08 |
drug1359 | Telemedicine Wiki | 0.08 |
drug592 | Hydroxychloroquine (HCQ) Wiki | 0.08 |
drug1034 | Placebo oral capsule Wiki | 0.08 |
drug1302 | Standard treatment Wiki | 0.08 |
drug1073 | Presatovir Wiki | 0.07 |
drug1402 | Tocilizumab Wiki | 0.06 |
drug335 | Colchicine Wiki | 0.05 |
drug1172 | Ruxolitinib Wiki | 0.05 |
drug308 | Chloroquine Wiki | 0.05 |
drug608 | Hydroxychloroquine Sulfate Wiki | 0.04 |
drug760 | Lopinavir/ritonavir Wiki | 0.04 |
drug1042 | Placebos Wiki | 0.03 |
drug1035 | Placebo oral tablet Wiki | 0.03 |
drug129 | Azithromycin Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D012327 | RNA Virus Infections NIH | 0.26 |
D003333 | Coronaviridae Infections NIH | 0.20 |
D003141 | Communicable Diseases NIH | 0.19 |
D007239 | Infection NIH | 0.19 |
D018352 | Coronavirus Infections NIH | 0.16 |
D012141 | Respiratory Tract Infections NIH | 0.15 |
D030341 | Nidovirales Infections NIH | 0.13 |
D018357 | Respiratory Syncytial Virus Infections NIH | 0.13 |
D000208 | Acute Disease NIH | 0.13 |
D001987 | Bronchiectasis NIH | 0.13 |
D044342 | Malnutrition NIH | 0.13 |
D003384 | Coxsackievirus Infections NIH | 0.13 |
D000370 | Ageusia NIH | 0.13 |
D015817 | Eye Infections NIH | 0.13 |
D010608 | Pharyngeal Diseases NIH | 0.13 |
D055501 | Macrophage Activation Syndrome NIH | 0.13 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.12 |
D007251 | Influenza, Human NIH | 0.10 |
D007154 | Immune System Diseases NIH | 0.09 |
D006331 | Heart Diseases NIH | 0.09 |
D003231 | Conjunctivitis NIH | 0.09 |
D000257 | Adenoviridae Infections NIH | 0.09 |
D058070 | Asymptomatic Diseases NIH | 0.09 |
D012140 | Respiratory Tract Diseases NIH | 0.08 |
D003327 | Coronary Disease NIH | 0.08 |
D004211 | Disseminated Intravascular Coagulation NIH | 0.08 |
D008231 | Lymphopenia NIH | 0.08 |
D018184 | Paramyxoviridae Infections NIH | 0.08 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.07 |
D020141 | Hemostatic Disorders NIH | 0.05 |
D008173 | Lung Diseases, Obstructive NIH | 0.05 |
D001778 | Blood Coagulation Disorders NIH | 0.05 |
D016638 | Critical Illness NIH | 0.05 |
D008171 | Lung Diseases, NIH | 0.05 |
D020246 | Venous Thrombosis NIH | 0.05 |
D000857 | Olfaction Disorders NIH | 0.05 |
D004630 | Emergencies NIH | 0.04 |
D007249 | Inflammation NIH | 0.04 |
D013927 | Thrombosis NIH | 0.04 |
D055370 | Lung Injury NIH | 0.03 |
D011014 | Pneumonia NIH | 0.03 |
D011024 | Pneumonia, Viral NIH | 0.02 |
D013577 | Syndrome NIH | 0.02 |
D055371 | Acute Lung Injury NIH | 0.02 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002110 | Bronchiectasis HPO | 0.13 |
HP:0004395 | Malnutrition HPO | 0.13 |
HP:0000224 | Decreased taste sensation HPO | 0.13 |
HP:0011947 | Respiratory tract infection HPO | 0.12 |
HP:0000509 | Conjunctivitis HPO | 0.09 |
HP:0005521 | Disseminated intravascular coagulation HPO | 0.08 |
HP:0001928 | Abnormality of coagulation HPO | 0.07 |
HP:0002625 | Deep venous thrombosis HPO | 0.06 |
HP:0002088 | Abnormal lung morphology HPO | 0.05 |
HP:0000458 | Anosmia HPO | 0.05 |
HP:0002090 | Pneumonia HPO | 0.03 |
There are 59 clinical trials
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.
The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.
Description: The presence of Influenza A or Influenza B virus.
Measure: Detection of Respiratory Viruses Time: Specimens will be taken within 5 days of the appearance of symptoms.This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning. At the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants. The study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants. During the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed. Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza. The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees. The investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.
Description: Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified
Measure: Number of viral respiratory tract infection in participants according to etiology Time: 6 monthsDescription: Serum concentration of vitamine D will be measured retrospectively from the blood samples taken at the beginning of the study and correlation between vitamine D concentration and the frequency of respiratory tract infection in participants will be made
Measure: Serum vitamine D concentration in participants Time: 6 monthsDescription: Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.
Measure: Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents Time: 6 monthsBronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway flow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.
Description: Respiratory viruses in the nasal swab and sputum will be identified using the polymerase chain reaction(PCR)technique when clinically stable and during exacerbation.The following viruses will be tested for:influenza A,B(including influenza A H1N1),respiratory syncytial virus(RSV),Enterovirus,Parainfluenza 1-4,Rhinovirus,human Coronaviruses(subtypes OC43、229E、HKU1),human metapneumovirus,adenovirus, human bocavirus,chlamydia,mycoplasma.
Measure: The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable. Time: 1 yearDescription: Systemic and airway inflammatory cytokines including IL-1β、IL-6、IL-8、TNF-a were measured using a commercial multiplex bead-based assay.
Measure: The effect of respiratory virus infection on systemic and pulmonary inflammatory markers. Time: 1 yearDescription: Spirometric indices in the present study is referred to as forced expiratory vilume in 1s(FEV1),forced vital capacity(FVC).Spirometry tests are carried out using a spirometer (COSMED, QUARK PFT, Italy). All operation procedures meet the joint recommendation by ATS and ERS. A total of at least 3 (not more than 8) spirometric maneuvers are performed, with the variation between the best two maneuvers of <5% or 200ml in FVC and FEV1. The maximal values of FVC and FEV1 are reported.
Measure: The effect of respiratory virus on lung function Time: 1 yearDescription: Type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter
Measure: The effect of respiratory virus infection on the bacterial load in bronchiectasis. Time: 1 yearDescription: The time from exacerbation onset by which a 3-d moving average was equal to or exceeded the baseline value
Measure: Time to recovery of respective symptom Time: 1 yearDescription: Quality of life in patients with bronchiectasis were measured by St.George Respiratory Questionnaire、Leicester Cough Questionnaire and COPD assessment test during exacerbations,and then compared between virus-postive and virus-negative patients
Measure: The effect of respiratory virus on quality of life in patients with bronchiectasis Time: 1 yearThe purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.
The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.
Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Measure: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 Time: Up to 7 daysDescription: FEV1 is defined as forced expiratory volume in the first second.
Measure: Percent Change From Study Baseline in FEV1% Predicted Value Time: Baseline; Day 28This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.
The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.
Description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measure: Time to Alleviation of All ARVI Symptoms. Time: 14 days of observation.Description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).
Measure: Time to Normalization of Body Temperature. Time: 14 days of observation.Description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.
Measure: Time to Alleviation of Flu-like Nonspecific Symptoms. Time: 14 days of observation.Description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.
Measure: Time to Alleviation of Respiratory Symptoms. Time: 14 days of observation.Description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6. Time: On days 2-6 of the observation period.Description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.
Measure: ARVI Severity. Time: On days 2-6 of the observation period.Description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).
Measure: Percentage of Recovered Patients. Time: On days 2-6 of the observation period.Description: Based on patient diary data. The number of intakes of prescribed antipyretics.
Measure: Rates of Antipyretics Use Per Patient. Time: On days 1- 5 of the treatment period.Description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).
Measure: Percentage of Patients With Worsening of Illness. Time: 14 days of observation peiod.The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
Description: The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.
Measure: Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Time: Up to Day 28Description: The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.
Measure: Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC) Time: Up to Day 28Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measure: Number of Participants with Adverse Events (AEs) Time: Up to 49 DaysDescription: Percentage of participants with abnormal clinical laboratory findings will be reported.
Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings Time: Up to 49 daysDescription: Percentage of participants with abnormal ECGs findings will be reported.
Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings Time: Up to 49 daysDescription: Percentage of participants with abnormal vital signs findings will be reported.
Measure: Percentage of Participants with Abnormal Vital Signs Findings Time: Up to 49 daysDescription: The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality) Time: Up to 49 daysDescription: Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to death (all-cause mortality) will be reported.
Measure: Proportion of Participants Progressing to Death (All-cause Mortality) Time: Up to 49 daysDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Time: Up to 49 daysDescription: Number of supplemental O2 free days will be reported.
Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28 Time: Through Day 28Description: Incidence of supplemental oxygen requirement in participants will be reported.
Measure: Incidence of Supplemental Oxygen Requirement Time: Up to 28 daysDescription: Duration of supplemental oxygen requirement in participants will be reported.
Measure: Duration of Supplemental Oxygen Time: Up to 28 daysDescription: Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Respiratory Rate Time: Baseline up to 49 daysDescription: Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Heart Rate Time: Baseline up to 49 daysDescription: Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Time: Baseline up to 49 daysDescription: Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Body Temperature Time: Baseline up to 49 daysDescription: Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.
Measure: Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline) Time: Up to 49 daysDescription: Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.
Measure: Proportion of Participants Re-hospitalized Time: Up to 49 daysDescription: Total length of hospital stay (time in hospital from first dosing) will be reported.
Measure: Total Length of Hospital Stay Time: Up to 49 daysDescription: Total time in the ICU (time in ICU from first dosing) will be reported.
Measure: Total Time in the Intensive Care Unit (ICU) Time: Up to 49 daysDescription: Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.
Measure: Incidence of Grade 3 and Grade 4 Adverse Events (AEs) Time: Up to 49 daysDescription: Incidence of respiratory AEs will be reported.
Measure: Incidence of Respiratory AEs Time: Up to 49 daysDescription: Incidence of thoracic-related AEs will be reported.
Measure: Incidence of Thoracic-related AEs Time: Up to 49 daysDescription: Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.
Measure: Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Time: Up to 49 daysDescription: Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.
Measure: Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28 Time: Baseline up to Day 28Description: Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.
Measure: Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale Time: Up to 49 daysDescription: Change from baseline in PGI-H scale through Day 28 will be reported.
Measure: Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28 Time: Baseline up to Day 28Description: Change from baseline in PGI-C scale through Day 28 will be reported.
Measure: Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28 Time: Baseline up to Day 28Description: AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.
Measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678 Time: Up to 24 hours postdose (on Days 1 and 8)Description: Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
Measure: Trough Plasma Concentration (Ctrough) of JNJ-53718678 Time: Predose on Days 1 and 8Description: Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.
Measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 Time: Predose; 0.5, 1, 1.5, 2, 4, 8, 24 hours postdose (on Days 1 and 8)Description: The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity Time: Up to 49 daysDescription: The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters Time: Up to 49 daysDescription: The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes Time: Up to 49 daysDescription: RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.
Measure: RSV Viral Load and Change from Baseline Over Time Time: Baseline up to Day 28Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.
Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 8, 11, 15, 22 and 28 Time: Baseline up to Days 8, 11, 15, 22 and 28Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Measure: Time to Undetectable RSV Viral Load Time: Up to 49 daysDescription: Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.
Measure: Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint Time: Up to 49 daysDescription: Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.
Measure: Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28 Time: Baseline up to Day 28Description: Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.
Measure: Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28 Time: Baseline up to Day 28Description: Change from baseline in the RSV F gene sequence will be reported.
Measure: Change from Baseline in the RSV F Gene Sequence Time: Baseline up to 49 daysCOVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Description: Evaluation of Pneumonia Improvement
Measure: Size of lesion area and severity of pulmonary fibrosis by chest CT Time: At Baseline , Day 6, Day 10, Day 14, Day 28 and Day 90Description: Evaluation of Pneumonia Improvement No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
Measure: mMRC (Modified Medical Research Council) dyspnea scale Time: Baseline , Day 7, Day 14, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Oxygenation index( PaO2/FiO2) Time: Baseline , Day 7, Day 14, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Duration of oxygen therapy(days) Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Duration of hospitalization(days) Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Blood oxygen saturation Time: Baseline , Day 7, Day 14, Day 28, Day 90Description: Marker of Immunological function
Measure: CD4+ T cell count and cytokine level Time: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90Description: Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measure: Side effects in the MSCs treatment group Time: Baseline , Day 3, Day 6,Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: 6-minute walk test Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Maximum vital capacity (VCmax) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Diffusing Capacity (DLCO) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported. The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2. Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals. The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals. Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.
Description: The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.
Measure: nosocomial infection Time: At inclusionThe study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.
Description: Death event
Measure: Survival rate Time: 12 weeksDescription: inflammatory indicator
Measure: body temperature Time: 2 weeksThe purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 3 monthsThe Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.
Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission
Measure: Maternal and perinatal outcomes Time: during gestation and at the time of delivery of the babyIn the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.
Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples
Measure: Rate of decline in SARS-CoV-2 viral load Time: Baseline (at randomization) and at 96 hoursDescription: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.
Measure: Change in National Early Warning Score score Time: Baseline (at randomization) and at 96 hoursDescription: Transfer from regular ward to intensive care unit during index admission
Measure: Admission to intensive care unit Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality during index admission
Measure: In-hospital mortality Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Measure: Duration of hospital admission Time: During index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality assessed at 30 and 90 days
Measure: Mortality at 30 and 90 days Time: At follow-up 30 and 90 daysDescription: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities
Measure: Clinical status Time: 14 days after randomizationDescription: Change in C-reactive protein concentrations from randomization to 96 hours after randomization
Measure: Change in C-reactive protein concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in alanine aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in aspartate aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in bilirubin concentrations from randomization to 96 hours after randomization
Measure: Change in bilirubin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization
Measure: Change in estimated glomerular filtration rate Time: Baseline (at randomization) and at 96 hoursDescription: Change in cardiac troponin concentrations from randomization to 96 hours after randomization
Measure: Change in cardiac troponin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization
Measure: Change in natriuretic peptide concentrations Time: Baseline (at randomization) and at 96 hoursThe Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.
Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission
Measure: Maternal and perinatal outcomes Time: at the time of deliveryThis study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysCoronavirus disease 2019 (COVID-19) is caused by the newly discovered coronavirus, SARS-CoV-2. The median time from onset of symptoms of COVID-19 to development of acute respiratory distress syndrome (ARDS) has been reported as short as 9 days. No effective prophylactic or post-exposure therapy is currently available. According to data from the Danish Health Authority (www.sst.dk/corona), as of March 21st, 2020, there were 1326 patients infected with the disease in Denmark, more than 250 are admitted to a hospital, and >50 of them have required intensive care. Nearly 350.000 cases and 15.000 deaths have been reported globally. These numbers are likely to markedly increase during the coming weeks, challenging the capacity of health systems worldwide. In patients infected with SARS-CoV-2, it has been described that disease severity and outcomes are related to the characteristics of the immune response. Interleukin (IL)-6 and other components of the inflammatory cascade contribute to host defense against infections. However, exaggerated synthesis of IL-6 can lead to an acute severe systemic inflammatory response known as 'cytokine storm'. In the pathogenesis of SARS-CoV-2 pneumonia, a study found that a cytokine storm involving a considerable release of proinflammatory cytokines occurred, including IL-6, IL-12, and tumor necrosis factor α (TNF-α). Studies on the Middle East respiratory syndrome caused by another coronavirus (MERS-CoV), indicate that cytokine genes of IL-6, IL-1β, and IL-8 can be markedly upregulated. Similarly, patients with SARS-CoV-2 pneumonia admitted to an intensive care unit had higher plasma levels of cytokines including IL-6, IL-2, IL-7, IL-10, granulocyte-colony stimulating factor (G-CSF), interferon-γ-inducible protein (IP10), monocyte chemoattractant protein (MCP1), macrophage inflammatory protein 1 alpha (MIP1A), and TNF-α. These findings indicate that the magnitude and characteristics of the cytokine response is related to the severity and prognosis of patients with SARS-CoV-2 pneumonia. It has been suggested that IL-6 blockade may constitute a novel therapeutic strategy for other types of cytokine storm, such as the systemic inflammatory response syndrome including sepsis, macrophage activation syndrome and hemophagocytic lymphohistiocytosis. Remarkable beneficial effects of IL-6 blockade therapy using a IL-6 receptor inhibitor has been described in patients with severe SARS-CoV-2 pneumonia in a retrospective case series from China. Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi). IL-6 receptor inhibitors are currently licensed for several autoimmune disorders and are considered well tolerated and safe in general. The most common side effects reported are upper respiratory tract infections, headache, hypertension, and abnormal liver function tests. The most serious side effects are serious infections, complications of diverticulitis, and hypersensitivity reactions. it is hypothesized that IL-6 might play a key role in the cytokine storm associated with serious adverse outcomes in patients infected with SARS-CoV-2 pneumonia, and that blockade of IL-6 would be suitable therapeutic target for these patients. The study will investigate the effect of different types of IL-6 inhibition versus no adjuvant treatment compared to standard of care in patients with severe SARS-CoV-2 pneumonia. Primary objective: To compare the effect of either one of three IL-6 inhibitor administrations, relative to the standard of care, on time to independence from supplementary oxygen therapy, measured in days from baseline to day 28, in patients with severe SARS-CoV-2 pneumonia.
Description: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: baselineDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: peak during hospitalisation, up to 28 daysDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: 14 daysDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: 28 daysDescription: Measured as occurrence of any serious adverse events
Measure: Number of participants with serious adverse events Time: During treatment, up to 28 daysResearchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.
Description: Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients
Measure: ICU and hospital mortality of COVID-19 patients Time: 7 daysDescription: Secondary outcome will be to measure 30 days mortality from Hospital discharge
Measure: 30 days mortality Time: 30 daysCOVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.
Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard
Measure: SAMBA COVID-19 POC PCR Test Time: 28 daysDescription: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
Measure: Patient acceptability Time: 28 daysDescription: Time to positive IgM/IgG test positivity
Measure: Immune Response Positivity Time: 40 daysBased on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.
Description: Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
Measure: Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee Time: 3 weeksDescription: Maximal concentration of high-sensitivity cardiac troponin
Measure: Maximal concentration of cardiac troponin Time: 10 daysCoronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR. It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors. It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.
Description: Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19
Measure: Coinfections Time: during ICU stay, up to 28 daysDescription: it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)
Measure: Respiratory dysfunction requiring mechanical ventilation Time: during ICU stay, up to 28 daysDescription: the SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: during ICU stay, up to 28 daysDescription: APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.
Measure: SAPS II score Time: at admissionDescription: The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained
Measure: Disseminated Intravascular Coagulation (DIC) score Time: during ICU stay, up to 28 daysDescription: measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.
Measure: Short Form 36 Time: at 9 months +/- 3 months after ICU stayDescription: The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Hospital anxiety and depression scale (HADS) Time: at 9 months +/- 3 months after ICU stayDescription: 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection
Measure: Impact of Event Scale - revised (IES-R) Time: at 9 months +/- 3 months after ICU stayDescription: Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5) Time: at 9 months +/- 3 months after ICU stayDescription: The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection
Measure: Modified Medical Research Council (MMRC) Dyspnea Scale Time: at 9 months +/- 3 months after ICU stayDescription: Evolution of viral clearance in nasal and depp PCR during ICU
Measure: Viral clearance Time: through study completion, an average of 28 daysThe coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.
Description: From blood samples: protein levels, whole genome sequence, transcriptomic analysis data. From upper respiratory samples: protein levels, virus transcriptomic analysis data. From stool: microbiota analysis data. From urine: protein level.
Measure: COVID-19 desease description Time: Inclusion visit (Day 1)Description: From blood samples: protein levels.
Measure: COVID-19 desease description Time: Day 30 to 90To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Measure: Viral nucleic acid test negative conversion rate Time: 5 monthsDescription: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 5 monthsTo evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Description: Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Measure: Changes in high-resolution computer tomography of the lung Time: 3 monthsDescription: St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.
Measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire Time: 3 monthsDescription: mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores Time: 3 monthsDescription: Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Measure: Changes in vital capacity of the lung Time: 3 monthsBackground: Aim: To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design, participants and interventions: Prospective, randomized, parallel group, double-blinded, placebo controlled, study. including 440 participants who will be randomised to 2 treatment arms: hydroxychloroquine or placebo. Outcome variables: symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR, viral load during SARS-CoV-2 infection, seroconversion during the study period, incidence of any acute respiratory infection, days of sick leave. Statistical considerations: No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers. Thus, sample size calculations in the proposed trial are based on the investigators' best estimates for several parameters. In accordance to the effect of oseltamivir against symptomatic influenza, we assumed an approximate effectiveness of approximately 60% (HR of 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) as realistic. As a prophylactic intervention with HCQ, which may have side effects and for which supply shortage can be expected, was judged justifiable only if its effectiveness is high, we based our sample size consideration on a HR of 0.3. To estimate the probability of an event in both the experimental and the control group, very little data is available. In a Dutch point-prevalence study 0-10% of health-care workers were infected depending on the healthcare institution, depending on the hospital. This point-prevalence study was performed between 6 and 9 March, when the reported number of cases in the Netherlands was 33 and 77, respectively, according to the RIVM (https://www.rivm.nl/nieuws/resultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus). Additionally, in an a report published in the Lancet, 20% of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-2003 30191539568.html). As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. PCR positivity) probability of 10% in the control group and 3% in the experimental arm after the maximum study period. In summary, a sample size of 210 participants per arm is necessary to detect a HR of 0.3 with a power of 80.3% with an alpha-error of 0.05. To account for drop-outs and asymptomatic, undetected infection at inclusion or past infection with existing immunity, an additional 10 participants will randomized per treatment arm. The overall study population is therefore 440 participants. Statistical analysis will be based on two populations: A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline. And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80% of all doses of study medication.
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
Description: children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies
Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients Time: at the end an average 28 daysDescription: the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency
Measure: Contact frequency Time: At inclusionOur aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Measure: Change of baseline total sequential organ failure assessment (SOFA) score Time: Visit study day 8Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Measure: Improvement of lung involvement measurements Time: Visit study day 8Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Measure: Increase of pO2/FiO2 ratio Time: Visit Study Day 8Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of sequential organ failure assessment (SOFA) score Time: Day 28Description: Mortality on day 28
Measure: Rate of Mortality Time: Day 28Description: Mortality on day 90
Measure: Rate of Mortality Time: Day 90Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Cytokine stimulation Time: Screening, Day 4Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Gene expression Time: Screening, Day 4Description: Change of serum/plasma proteins between days 0 and 4
Measure: Serum/plasma proteins Time: Screening, Day 4Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation
Measure: Classification of the immune function Time: ScreeningThere is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources. This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.
Description: Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death
Measure: Rate of secondary aggravation Time: At 30 days of admission to the emergency departmentDescription: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.
Measure: Change of standart biological parameters Time: Between baseline and at 30 days of admission to the emergency departmentSummary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: - Extent of age-specific infection and antibody formation - Cumulative incidence of infection - Rate of asymptomatic infection - Relationship with socioeconomics, lifestyle and risk factors (comorbidities) Study design: Prospective, longitudinal, stratified by age and gender Duration of study: Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months) Information to be obtained from participants: - serum samples for information on SARS-CoV2 infection and antibody formation - data on clinical symptoms
Description: Antibody Titres IgG and IgM
Measure: Prevalence of SARS-CoV-2 antibody titres Time: 5 weeksDescription: Re-Calculation including incidence of the general population
Measure: Prevalence of SARS-CoV-2 antibody titres after 3 Months Time: 4 MonthsThe goal of the research is to assess candidate COVID-19 rapid (5-15 min) antibody tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by a mobile device camera acquisition software and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of finger-stick capillary blood self-testing assisted by mobile device imaging and telemedicine remote support.
Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test
Measure: Clinical accuracy of the antibody-based rapid tests compared to PCR-based test result Time: 1 yearDescription: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and a clinical diagnosis of COVID-19
Measure: Clinical accuracy of the rapid tests based on Clinical diagnosis Time: 1 yearDescription: Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician
Measure: Self-test interpretation of result vs expert clinical image interpretation of result Time: 1 yearDescription: Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)
Measure: Ease of self-testing procedure Time: 1 yearCoronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.
Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
Measure: Fibrosis Time: 12 monthsDescription: Decreased functional capacity on ergospirometers
Measure: Ergospirometers Time: 12 monthesThe purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Measure: Safety of in-hospital thromboprophylaxis Time: Day 30Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).
Measure: Median twice-daily enoxaparin dose Time: 4 hours post initial doseDescription: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalizedDescription: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE Time: Day 30Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).
Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support Time: Day 30The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.
Description: The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.
Measure: Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. Time: within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCRInflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsIn the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.
Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.
Measure: The ratio of patients who will not develop serious respiratory failure (SRF) Time: Visit study day 14Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database Time: Visit study day 14Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of SOFA score in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7
Measure: Change of cytokine production between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7
Measure: Change of plasma inflammatory mediators levels between days 1 and 7 Time: Visit study day 1, visit study day 7This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score or radiologic evaluation as measured by protocol-defined radiologic evaluation score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by Radiologic Evaluation Score.
Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score Time: Up to 28 daysDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 monthsPurpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Description: Presence or absence of IgG antibodies to SARS-CoV2
Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Time: at enrollmentDescription: swab for presence of SARS-CoV-2 virus
Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. Time: at enrollmentProphylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Description: assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)
Measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections Time: 12 weeks after initiation of therapyDescription: defined as combined endpoint of hospitalization rate or death
Measure: Number of severe COVID-19 cases Time: 12 weeks after initiation of therapyDescription: grading as outlined by the world health organization (WHO)
Measure: Severity of COVID-19 cases Time: 12 weeks after initiation of therapyDescription: significant clinical and laboratory abnormalities according to CTCAE criteria
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 12 weeks after initiation of therapyDescription: other than COVID-19
Measure: Number of viral and bacterial infections Time: 12 weeks after initiation of therapyDescription: Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
Measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test Time: 12 weeks after initiation of therapySevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.
Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples
Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2 Time: 1 yearDescription: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of patients developed COVID-19 divided by the number of the study population
Measure: Rate of development of COVID-19 in the study patient population Time: 1 yearDescription: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19
Measure: Positive conjunctival sample rate in patient developed COVID-19 Time: 1 yearThis is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upDescription: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 yearThe overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children
Description: measure by two rt-PCR COVID-19 tests regardless the serological status of the child
Measure: evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice Time: at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the serological prevalence of the Covid-19 infection Time: at inclusion and at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the COVID-19 reinfection among seropositive children at the inclusion time Time: at inclusion and at 42 daysDescription: positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)
Measure: evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus) Time: at 42 daysDescription: measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
Measure: comparison of inflammatory response level between different coronavirus strains Time: at 42 daysDescription: measure of the medico-social relative risk associated with rt-PCR COVID-19 test positivity among : school level, gender, school type, day care facilities before 11th May, number of siblings, housing type, number of bedrooms, precariousness level, by score EPICES ( (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'examens de santé, means Assessment of precariousness and health inequalities in health examination centers). Questionnaire of EPICES counts 11 items, the answer to each question is assigned a coefficient, the sum of the 11 answers gives the score EPICES. The score is continuous, it varies from 0 (lack of precariousness) to 100 (maximum precariousness).
Measure: Estimation of medico-social risk factors associated with COVID-19 infection Time: at 42 daysThe trial has two parts: a dose-finding part (Part A) with four dose cohorts (treatment groups) for each vaccine and one pre-defined and one optional dose level for a de-escalation approach and, a second part (Part B) dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, and BNT162b2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will be administered using a Single dose (SD) regimen.
Description: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationDescription: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationCOVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Description: days of ICU stay
Measure: Length of ICU stay Time: up to 60 daysDescription: days of hospital stay
Measure: Length of hospital stay Time: up to 90 daysELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.
Description: Time until participant reports well
Measure: Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'. Time: Maximum of 14 daysDescription: Recorded using validated WURSS-24 questionnaire and daily diaries
Measure: Severity of all symptoms Time: 1-14 days or until the participant reports that they are wellDescription: Recorded using validated WURSS-24 questionnaire and daily diaries
Measure: The length of time for individual symptoms to resolve Time: 1-14 days or until the participant reports that they are wellDescription: Recorded using validated WURSS-24 questionnaire and daily diaries
Measure: Severity of individual symptoms Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants and frequency of contacts
Measure: Contacting healthcare (NHS 24, OOH, GP) Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants and frequency of contacts
Measure: Participants needing GP appointments Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants
Measure: Participants attending hospital Time: 1-14 days or until the participant reports that they are wellDescription: Number of days
Measure: Length of stay in hospital if admitted Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants
Measure: Number of participants reporting over the counter medication use Time: 1-14 days or until the participant reports that they are wellDescription: Number of people within participant's household who develop symptoms
Measure: Reduction in transmission to household contacts Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants in intervention arm reporting side effects
Measure: Number of participants reporting side effects of nasal irrigation Time: 1-14 days or until the participant reports that they are wellDescription: Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe'
Measure: Types and severity of side effects reported Time: 1-14 days or until the participant reports that they are wellDescription: Estimated cost requested when participant states over the counter medication used
Measure: Cost of over the counter medication used Time: 1-14 days or until the participant reports that they are wellIntroduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
Description: Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): respiratory failure that requires mechanical ventilation organ failure that requires intensive care monitoring and treatment death
Measure: Proportion of cases who during 14 exhibit one of the following conditions Time: 14 daysDescription: Mortality 28 days after randomization
Measure: Mortality 28 days after randomization Time: 28 daysBackground. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:
Description: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 1 MonthDescription: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 3 MonthsDescription: Usual weight at baseline vs weight before confinement (gk)
Measure: Weight changes during confinement Time: 8 weeksDescription: number and type of nutritional supplements from baseline
Measure: prescription of nutritional supplements and observance Time: 3 monthsCOVID-19 has adversely affected the healthcare system across the world. The world was not prepared for global outbreak of infectious diseases. The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is enabling researchers worldwide to acquire a large amount of clinical data regarding coronavirus disease (COVID-19). The COVID-19 infection severely affects the respiratory system in the critical cases and results in mortalities. The affected people experience a dry cough, fever, breathing problems, diarrhea, muscle pain, and sore throat. Besides that, some of the evidence from Italy, South Korea, China, and Spain suggest that the COVID-19 cases also lose their senses of smell and taste resulting in alterations in those patients. The objective of this proposed study is to determine whether COVID-19 cases have Olfactory and gustatory dysfunctions as a hallmark indicator and can be used as diagnostic tools for the isolation of suspected people. Investigators are presenting a prospective proportional case-control study that is conducted to investigate the COVID-19 cases with anosmia and /or Ageusia in a university hospital in Riyadh, Saudi Arabia. The sample size of this case series would be 250 cases of suspected COVID-19 patients. The cases included in the study are analyzed prospectively to determine if the cases had a history of anosmia and /or Ageusia, and then tested for the alteration of these senses through a panel of standardized odors/taste strips. That is looked at statistically allowing us to confirm the proposed effectiveness of these tests as a diagnostic tool.
Description: to how extent alteration of smell and taste senses is related to covid19 status
Measure: correlation of anosmia and ageusia to covid19 positive patients Time: from 1/06/2020 to 31/12/2020Description: to determine the range of sense affection ranging from total loss to mild form
Measure: objective assessment of severity of smell and taste senses alterations in covid19 patients Time: from 1/06/2020 to 31/12/2020Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) Time: Day 1 to Day 8Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline Time: Day 1 to Day 8Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4 Time: Day 4Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4 Time: Day 4Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)
Measure: Range of development of severe respiratory failure Time: Day 1 to Day 14Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.
Measure: Range of hospital readmission until day 14 Time: Day 1 to Day 14Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8
Measure: Change of viral load in respiratory secretions from baseline on day 8 Time: Day 1 to Day 8Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of function of monocytes at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th1 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th2 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of the IL-10/TNFα ratio between days 1 and 8 Time: Day 1 to Day 8SARS-CoV-2 transmission is frequently occurring in hospital settings, with numerous reported cases of nosocomial transmission highlighting the vulnerability of healthcare workers. If products proved to be efficacious against COVID-19, why are so many HCW getting COVID-19? Is it related to experience? Is it generated by the exhaustive job? Is there any degree of relationship to stress? These questions are still without fully correct answers. Achieving global benefits for HCW is still waiting.
Description: To assess the prevalence of surface contamination with COVID-19 from personal protective equipment (PPE) worn by medical doctors, immediately after evaluating sick patients
Measure: Asses surface contamination personel protective equipment Time: 2 monthsDescription: Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.
Measure: Virus charge cuantification Time: 2 monthsDescription: Determine the most frequent location of viruses inPPE
Measure: Place in PPE contamination Time: 2 monthDescription: using the information found, carry out tips to reduce the risk of contagion
Measure: Prevention risk advice Time: 2 monthSARS-CoV2-specific T cell lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. The cells are then frozen.These cells will be used to treat patients with confirmed SARS-CoV-2 infection who are at high risk of requiring mechanical ventilation.
Description: Primary end point: Treatment-related adverse events (tAE), including GVHD, worsening CRS, and any other treatment-related toxicities by day 14 post-infusion.
Measure: Safety of administering partially HLA-matched SARS-CoVSTs to hospitalized COVID19 patients with high risk of progression to mechanical ventilation. Time: 14 days post infusionDescription: Secondary endpoint: Improvement on the WHO Ordinal Scale by day 14 post-infusion.
Measure: Efficacy of anti-COVID19 of administering banked partially HLA-matched SARS-CoVSTs to hospitalized COVID19 patients. Time: 14 days post infusionBackground: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done.
Description: To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.
Measure: Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery. Time: Throughout the studyDescription: 1. Correlation of lymphopenia, immunologic phenotypes, and inflammatory responses with clinical outcomes. 2. Characterization of complement activation in patients with COVID-19. 3. Evaluation of activationinduced cell death and activated T cell autonomous death through measurement of intracellular reactive oxygen species in monocyte, natural killer (NK), and T cell subsets in peripheral blood and correlation with double stranded (ds)-DNA damage ( >=-H2AX), FAS/FasL, BCL-2, caspase-1 activation, and activation-induced proliferation. 4. Evaluation of homing receptors to lymphoid, skin, and mucosal surfaces on B and T cells and correlate with ACE2, bradykinin, and homing chemokine levels.
Measure: Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis. Time: Throughout the studyTo ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease Time: Measuring during 28-day period since randomization (Intention to treat analysis)Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)
Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization Time: Measuring during 14-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.
Measure: Time to clinical improvement Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;
Measure: Time to clinical failure Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with hospitalization for any cause
Measure: Hospitalization for any cause Time: Measuring during 28-day period since randomizationDescription: Evaluation of adverse events evaluated as associated to any of study arms
Measure: Proportion of participants who presented with adverse events Time: Measuring during 28-day period since randomizationDescription: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.
Measure: Time to improvement on respiratory scale symptoms Time: Measuring during 28-day period since randomizationThe purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.
Description: Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Measure: Successful production of viral specific T-cells Time: Within 30 days post culture initiationDescription: Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Measure: Presence of viral-specific T-cells Time: At 30 days after infusionIn this pilot trial, 120 confirmed COVID-19 individuals will be randomly assigned to 1 of 4 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), or Crest Pro-Health Multi-Protection (Crest, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 15 seconds, for 4 weeks.
Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load
Measure: Change in SARS-Cov-2 viral load Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization
Measure: Change in healthcare utilization and hospitalization Time: Baseline to 4 weeksDescription: Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers
Measure: Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers
Measure: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksThis observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measure: Identification of requirement of mechanical ventilation Time: 3 weeksDescription: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measure: Prediction of requirement of mechanical ventilation Time: 3 weeksDescription: Descriptive assessment of clinical parameters and LUS-score over time
Measure: Association of LUS to clinical parameters Time: 3 weeksDescription: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measure: Description of findings on LUS Time: 3 weeksBased on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria.
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)