Primary Outcomes

Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Testing Throughput After Hexapod Implementation

Time: Up to 22 weeks

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Description: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Isolation Gowns Utilized After Hexapod Utilization

Time: Up to 22 weeks

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Description: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.

Measure: Change in Cost per Test After Hexapod Implementation

Time: Up to 22 weeks

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Description: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.

Measure: Return on Investment

Time: Up to 22 weeks

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Secondary Outcomes

Description: The difference in median shift salaries before and after Hexapod implementation will be calculated.

Measure: Change in Testing Personnel Cost Per Test

Time: Up to 22 weeks

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Description: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.

Measure: Change in Cost of Isolation Gowns Utilized

Time: Up to 22 weeks

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Other Outcomes

Description: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.

Measure: Cost of Additional Consumable Supplies Utilized

Time: Up to 22 weeks

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Primary Outcomes

Measure: Death

Time: 60-day period following enrollment

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Secondary Outcomes

Measure: Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome

Time: approximately 60 days

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Primary Outcomes

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.

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Primary Outcomes

Description: January 2031

Measure: Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf...

Time: open-ended

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Primary Outcomes

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 months

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Secondary Outcomes

Description: 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 months

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Description: 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 months

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Primary Outcomes

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 year

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Secondary Outcomes

Description: 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 year

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Description: 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 year

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Description: 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 year

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Description: 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 year

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Description: 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 year

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Measure: To investigate if upper respiratory tract symptoms are associated with viral infections.

Time: 1 year

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Primary Outcomes

Measure: Freedom from new or progressive chronic lung allograft dysfunction

Time: 180 days

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Measure: Death

Time: 180 days

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Secondary Outcomes

Measure: Respiratory virus symptom score

Time: 7 days

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Measure: Acute rejection

Time: 180 days

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Measure: Lymphocytic bronchiolitis

Time: 180 days

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Measure: Donor-specific antibodies

Time: 180 days

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Measure: Chronic lung allograft dysfunction

Time: 365 days

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Primary Outcomes

Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

Time: Up to 7 days

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Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

Time: Up to 7 days

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Secondary Outcomes

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 days

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Description: FEV1 is defined as forced expiratory volume in the first second.

Measure: Percent Change From Study Baseline in FEV1% Predicted Value

Time: Baseline; Day 28

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Primary Outcomes

Measure: Numbers of infected patient

Time: Serologic confimred MERS case within 4 weeks after contacting to a case patients

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Primary Outcomes

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.

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Secondary Outcomes

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Primary Outcomes

Description: RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

Measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

Time: Baseline through Day 5

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Secondary Outcomes

Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline through Day 21

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Description: 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 3, 8, and 14

Time: Baseline through Days 3, 8 and 14

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Description: 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 21 days

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Description: Proportion of participants with undetectable RSV viral load will be reported.

Measure: Proportion of Participants with Undetectable RSV Viral Load at each timepoint

Time: Up to 21 days

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Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS)

Time: Up to 21 days

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Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days

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Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

Measure: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

Time: Baseline up to 21 days

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Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Measure: Change from Baseline in Clinician PRESORS Scores

Time: Baseline up to 21 days

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Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Measure: Time to Resolution of RSV Symptoms

Time: Up to 21 days

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Description: Time to improvement based on general questions on overall health will be reported.

Measure: Time to Improvement on Overall Health

Time: Up to 21 days

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Description: Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Measure: Proportion of Participants with Improvement or Worsening of RSV Disease

Time: Up to 21 days

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Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

Time: Up to 21 days

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Description: Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Measure: Proportion of Participants with Vital Sign Abnormalities

Time: Up to 28 days

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Description: Proportion of participants with abnormal body temperature will be reported.

Measure: Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s)

Time: Up to 28 days

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Description: Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.

Measure: Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up

Time: Up to 21 days

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Description: Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.

Measure: Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease

Time: Up to 21 days

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Description: Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.

Measure: Cohort 1: Time to Discharge

Time: Up to 21 days

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Description: Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU)

Time: Up to 21 days

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Description: In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of ICU Stay

Time: Up to 21 days

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Description: Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen

Time: Up to 21 days

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Description: Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of Supplemental Oxygen

Time: Up to 21 days

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Description: Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support

Time: Up to 21 days

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Description: Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support

Time: Up to 21 days

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Description: Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Non-invasive Ventilator Support

Time: Up to 21 days

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Description: Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Invasive Ventilator Support

Time: Up to 21 days

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Description: Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube

Time: Up to 21 days

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Description: Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.

Measure: Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator

Time: Up to 21 days

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Description: Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.

Measure: Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms

Time: Up to 21 days

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Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Measure: Percentage of Participants with Adverse Events

Time: Up to 28 days

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Description: Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.

Measure: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days

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Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 21 days

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Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Measure: Plasma Concentrations of JNJ-53718678

Time: Days 1 and 3

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Description: Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.

Measure: Medical Resource Utilization

Time: Up to 28 days

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Description: Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.

Measure: Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)

Time: Day 8

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Description: Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.

Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences

Time: Up to 21 days

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Primary Outcomes

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 28

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Secondary Outcomes

Description: 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 28

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Description: 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 days

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Description: Percentage of participants with abnormal clinical laboratory findings will be reported.

Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings

Time: Up to 49 days

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Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 49 days

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Description: Percentage of participants with abnormal vital signs findings will be reported.

Measure: Percentage of Participants with Abnormal Vital Signs Findings

Time: Up to 49 days

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Description: 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 days

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Description: 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 days

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Description: 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 days

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Description: 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 1 year

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Description: 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 days

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Description: 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 days

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Description: Number of supplemental O2 free days will be reported.

Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28

Time: Through Day 28

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Description: Incidence of supplemental oxygen requirement in participants will be reported.

Measure: Incidence of Supplemental Oxygen Requirement

Time: Up to 28 days

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Description: Duration of supplemental oxygen requirement in participants will be reported.

Measure: Duration of Supplemental Oxygen

Time: Up to 28 days

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Description: 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 days

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Description: 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 days

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Description: 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 days

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Description: 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 days

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Description: 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 1 year

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Description: 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 1 year

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Description: Total length of hospital stay (time in hospital from first dosing) will be reported.

Measure: Total Length of Hospital Stay

Time: Up to 49 days

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Description: 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 days

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Description: 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 days

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Description: Incidence of respiratory AEs will be reported.

Measure: Incidence of Respiratory AEs

Time: Up to 49 days

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Description: Incidence of thoracic-related AEs will be reported.

Measure: Incidence of Thoracic-related AEs

Time: Up to 49 days

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Description: 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 days

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Description: 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 days

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Description: 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 28

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Description: 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 days

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Description: 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 28

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Description: 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 28

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Description: 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)

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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 8

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Description: 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: Day 1

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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 days

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Description: 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 days

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Description: 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 days

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Description: 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 28

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Description: 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 28

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Description: 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 days

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Description: 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 days

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Description: 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 28

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Description: 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 28

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Description: 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 days

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Primary Outcomes

Description: Respiratory Syncytial Virus (RSV) viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.

Measure: Part 2: RSV Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

Time: On the day of diagnosis (Baseline) through Day 5 of interventional stage

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Secondary Outcomes

Description: Total Respiratory Symptom Score over time will be captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive participants that do not enter in the interventional stage.

Measure: Part 1: Total Respiratory Symptom Score Over Time

Time: Up to 21 Days of observational stage

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Description: Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Measure: Part 1: Change from Baseline in Clinician Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Scores

Time: On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stage

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Description: RSV Viral load during pre-diagnostic phase will be determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens.

Measure: Part 1: RSV Viral Load

Time: Pre-diagnostic phase: Within 24hrs of Observation Day 1

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Description: RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) will be measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens.

Measure: Part 1: RSV Viral Load Kinetics from Day 1 to Day 8

Time: On the day of diagnosis (Baseline) through Day 8 of observational stage

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Description: Change from baseline in Parent(s)/Caregiver(s) PRESORS scores (worsening or improvement) will be reported.

Measure: Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time

Time: On the day of diagnosis (Baseline) up to 21 Days of the observational stage

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Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in mid-turbinate nasal swab specimens.

Measure: Part 2: RSV Viral Load and Change from Baseline Over Time

Time: On the day of diagnosis (Baseline) through Day 21 of interventional stage

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Description: RSV viral load AUC will be determined by qRT-PCR assay in mid-turbinate nasal swab specimens.

Measure: Part 2: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

Time: On the day of diagnosis (Baseline) through Days 3, 8 and 14 of interventional stage

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Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Measure: Part 2: Time to Undetectable RSV Viral Load

Time: Up to 21 days of interventional stage

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Description: Percentage of participants with undetectable RSV viral load will be reported.

Measure: Part 2: Percentage of Participants with Undetectable RSV Viral Load at each timepoint

Time: Up to 21 days of interventional stage

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Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Part 2: Duration of Signs and Symptoms of RSV Disease Assessed by the PRESORS

Time: Up to 21 days of interventional stage

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Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Part 2: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days of interventional stage

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Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

Measure: Part 2: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

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Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Measure: Part 2: Change from Baseline in Clinician PRESORS Scores

Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

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Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Measure: Part 2: Time to Resolution of RSV Symptoms

Time: Up to 21 days of interventional stage

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Description: Time to improvement based on general questions on overall health will be reported.

Measure: Part 2: Time to Improvement on Overall Health

Time: Up to 21 days of interventional stage

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Description: Percentage of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Measure: Part 2: Percentage of Participants with Improvement or Worsening of RSV Disease

Time: Up to 21 days of interventional stage

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Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Measure: Part 2: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

Time: Up to 21 days of interventional stage

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Description: Percentage of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Measure: Part 2: Percentage of Participants with Vital Sign Abnormalities

Time: Up to 28 days of interventional stage

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Description: Percentage of participants who require (re)hospitalization during treatment and follow-up will be reported.

Measure: Part 2: Percentage of Participants who Require (re)Hospitalization During Treatment and Follow-up

Time: Up to 28 days of interventional stage

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Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Measure: Part 2: Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability

Time: Up to 28 days of interventional stage

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Description: Percentage of participants with abnormal laboratory findings (hematology, biochemistry, urinalysis) will be reported.

Measure: Part 2: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days of interventional stage

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Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Part 2: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 28 days of interventional stage

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Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Measure: Part 2: Plasma Concentrations of JNJ-53718678

Time: Day 1 and Day 3 of interventional stage

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Primary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 28.

Time: Day 28

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Secondary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90

Time: Day 10, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening

Time: Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)

Time: Day 10, Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

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Description: Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale: Not hospitalized; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Time to clinical improvement in 28 days.

Time: Day 28

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Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index( PaO2/FiO2)

Time: Day 6, Day 10, Day 28

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Description: Evaluation of Pneumonia Improvement

Measure: Duration of oxygen therapy(days)

Time: Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Blood oxygen saturation

Time: Day 6, Day 10, Day 28

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Description: Evaluation of Pneumonia Improvement

Measure: 6-minute walk test

Time: Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Maximum vital capacity (VCmax)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

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Description: Evaluation of Pneumonia Improvement

Measure: Diffusing Capacity (DLCO)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

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Description: 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: Day 28, Day 90

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Description: Marker of Immunological function

Measure: Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

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Description: Marker of Immunological function

Measure: Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

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Description: Safety endpoints

Measure: Adverse events

Time: Day 0 through Day 90

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Description: Safety endpoints

Measure: Serious adverse events

Time: Day 0 through Day 90

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Description: Safety endpoints

Measure: All-cause mortality

Time: Day 0 through Day 90

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Primary Outcomes

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 inclusion

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Primary Outcomes

Description: Death event

Measure: Survival rate

Time: 12 weeks

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Secondary Outcomes

Description: inflammatory indicator

Measure: body temperature

Time: 2 weeks

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Primary Outcomes

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 months

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Secondary Outcomes

Measure: Viral nucleic acid test negative conversion rate and days from positive to negative

Time: 14 days after taking medicine

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Measure: Duration of fever

Time: 14 days after taking medicine

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Measure: Lung imaging improvement time

Time: 14 days after taking medicine

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Measure: Mortality rate because of Corona Virus Disease 2019

Time: 3 months

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Measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs

Time: 3 months

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Measure: Mean in-hospital time

Time: 3 months

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Primary Outcomes

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 baby

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Primary Outcomes

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 hours

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Secondary Outcomes

Description: 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 hours

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Description: 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)

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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)

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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)

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Description: All-cause mortality assessed at 30 and 90 days

Measure: Mortality at 30 and 90 days

Time: At follow-up 30 and 90 days

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Description: 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 randomization

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Description: 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 hours

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Description: 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 hours

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Description: 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 hours

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Description: Change in bilirubin concentrations from randomization to 96 hours after randomization

Measure: Change in bilirubin concentrations

Time: Baseline (at randomization) and at 96 hours

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Description: 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 hours

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Description: 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 hours

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Description: 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 hours

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Primary Outcomes

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 delivery

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Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

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Secondary Outcomes

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 days

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Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

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Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

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Measure: Mortality

Time: 30 days

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Measure: Length of hospitalization

Time: 14 days

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Measure: Days alive and discharged from hospital

Time: 30 days

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Measure: Mortality

Time: 90 days

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Measure: Mortality

Time: 365 days

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Measure: Number of readmissions (all causes)

Time: 30 days

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Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

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Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

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Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

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Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

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Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

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Primary Outcomes

Measure: Time to independence from supplementary oxygen therapy

Time: days from enrolment up 28 days

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Secondary Outcomes

Measure: Number of deaths

Time: 28 days from enrolment

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Measure: Days out of hospital and alive

Time: 28 days from enrolment

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Measure: Ventilator free days alive and out of hospital

Time: 28 days from enrolment

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Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: baseline

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Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: peak during hospitalisation, up to 28 days

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Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: 14 days

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Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: 28 days

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Description: Measured as occurrence of any serious adverse events

Measure: Number of participants with serious adverse events

Time: During treatment, up to 28 days

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Primary Outcomes

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 days

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Secondary Outcomes

Description: Secondary outcome will be to measure 30 days mortality from Hospital discharge

Measure: 30 days mortality

Time: 30 days

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Primary Outcomes

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 days

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Secondary Outcomes

Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

Measure: Patient acceptability

Time: 28 days

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Description: Time to positive IgM/IgG test positivity

Measure: Immune Response Positivity

Time: 40 days

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Primary Outcomes

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 weeks

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Description: Maximal concentration of high-sensitivity cardiac troponin

Measure: Maximal concentration of cardiac troponin

Time: 10 days

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Primary Outcomes

Measure: Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU

Time: within 24 hours of admission to ICU

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Secondary Outcomes

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 days

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Description: 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 days

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Description: 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 days

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Description: 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 admission

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Description: 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 days

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Measure: Number of days on vasopressive amines

Time: during ICU stay, up to 28 days

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Measure: Occurrence of an event of venous or arterial thromboembolic disease

Time: during ICU stay, up to 28 days

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Measure: Number of days with extra renal treatment (ERA)

Time: during ICU stay, up to 28 days

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Measure: Number of patients alive after ICU stay less than 28 days will be tracked

Time: At 28 day

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Description: 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 stay

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Description: 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 stay

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Description: 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 stay

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Description: 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 stay

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Description: 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 stay

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Measure: Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters

Time: until day 28 after admission of ICU

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Description: Evolution of viral clearance in nasal and depp PCR during ICU

Measure: Viral clearance

Time: through study completion, an average of 28 days

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Primary Outcomes

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)

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Description: From blood samples: protein levels.

Measure: COVID-19 desease description

Time: Day 30 to 90

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Primary Outcomes

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 months

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Secondary Outcomes

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: 5 months

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Primary Outcomes

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 months

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Measure: Change in 6-minute walking distance

Time: 3 months

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Secondary Outcomes

Measure: Changes in compound physiological index

Time: 3 months

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Description: 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 months

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Description: 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 months

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Description: 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 months

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Primary Outcomes

Measure: Symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR

Time: 4 weeks

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Secondary Outcomes

Measure: Viral load during SARS-CoV-2 infection

Time: 4 weeks

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Measure: Seroconversion during the study period

Time: 4 weeks

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Measure: Incidence of any acute respiratory infection

Time: 4 weeks

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Measure: Days of sick leave

Time: 4 weeks

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Primary Outcomes

Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR

Time: At 28 days

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Secondary Outcomes

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 days

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Measure: Respiratory signs of children tested within 28 day

Time: through study completion, an average 28 days

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Measure: Percentage of children hospitalized tested within 28 day

Time: through study completion, an average 28 days

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Description: 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 inclusion

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Measure: Prevalence of positivity of other respiratory viruses measured by rt-PCR

Time: at 28 days

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Primary Outcomes

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 8

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Description: 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 8

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Description: 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 8

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Secondary Outcomes

Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 28

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Description: Mortality on day 28

Measure: Rate of Mortality

Time: Day 28

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Description: Mortality on day 90

Measure: Rate of Mortality

Time: Day 90

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Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Cytokine stimulation

Time: Screening, Day 4

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Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Gene expression

Time: Screening, Day 4

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Description: Change of serum/plasma proteins between days 0 and 4

Measure: Serum/plasma proteins

Time: Screening, Day 4

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Description: 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: Screening

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Primary Outcomes

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: an average at 30 days (- 2 days +3 days) of admission to the emergency department

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Secondary Outcomes

Description: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.

Measure: Change of standart biological parameters

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

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Measure: Change of Von willebrand factor (vWF) changes over time

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

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Measure: Change of the Factor VIII (FVIII)

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

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Measure: Prevalence of positivity of COVID-19 virus measured by PCR or serology

Time: an average at 30 days (- 2 days +3 days) of admission to the emergency department

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Primary Outcomes

Description: Analysis of all-cause death in relation with clinical patient profile

Measure: Death rate

Time: Through study completion, an average of 4 weeks

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Description: Correlation between clinical patient profile and transfer need to intensive care unit

Measure: Transfer to intensive care unit

Time: Through study completion, an average of 4 weeks

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Description: Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile

Measure: Ventilation analysis

Time: Through study completion, an average of 4 weeks

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Secondary Outcomes

Description: Description of clinical and biological patient profile leading to a worse prognosis

Measure: Construction of a predictive score for COVID-19 severe form

Time: Through study completion, an average of 4 weeks

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Primary Outcomes

Description: Antibody Titres IgG and IgM

Measure: Prevalence of SARS-CoV-2 antibody titres

Time: 5 weeks

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Secondary Outcomes

Description: Re-Calculation including incidence of the general population

Measure: Prevalence of SARS-CoV-2 antibody titres after 3 Months

Time: 4 Months

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Primary Outcomes

Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

Measure: Fibrosis

Time: 12 months

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Description: Decreased functional capacity on ergospirometers

Measure: Ergospirometers

Time: 12 monthes

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Primary Outcomes

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 30

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Secondary Outcomes

Description: 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 dose

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Other Outcomes

Description: 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 hospitalized

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Description: 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 30

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Description: 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 30

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Primary Outcomes

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-PCR

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Primary Outcomes

Description: nM;

Measure: ETP (AUC) without rhThrombomodulin (rhTM)

Time: 6 months

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Description: nM;

Measure: ETP (AUC) with rhThrombomodulin (rhTM)

Time: 6 months

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Description: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

Measure: ETP-ratio

Time: 6 months

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Description: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Measure: ETP-Normalisation

Time: 6 months

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Primary Outcomes

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 14

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Secondary Outcomes

Description: 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 14

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Description: 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 7

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Description: 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 14

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Description: 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 7

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Description: 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 14

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Description: 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 7

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Description: 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 7

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Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 6 months

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Description: 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 6 months

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Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.

Measure: Phase 1: Rate of clinical improvement

Time: Up to 6 months

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Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. 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 days

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Description: 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 days

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Secondary Outcomes

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 6 months

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Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 6 months

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Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 6 months

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Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 6 months

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Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 6 months

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Description: 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 days

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Description: 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 days

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Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

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Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days

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Primary Outcomes

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 enrollment

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Secondary Outcomes

Description: swab for presence of SARS-CoV-2 virus

Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.

Time: at enrollment

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Primary Outcomes

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 therapy

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Secondary Outcomes

Description: defined as combined endpoint of hospitalization rate or death

Measure: Number of severe COVID-19 cases

Time: 12 weeks after initiation of therapy

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Description: grading as outlined by the world health organization (WHO)

Measure: Severity of COVID-19 cases

Time: 12 weeks after initiation of therapy

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Description: 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 therapy

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Description: other than COVID-19

Measure: Number of viral and bacterial infections

Time: 12 weeks after initiation of therapy

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Description: 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 therapy

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Primary Outcomes

Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples

Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2

Time: 1 year

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Secondary Outcomes

Description: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

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Description: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

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Description: Number of patients developed COVID-19 divided by the number of the study population

Measure: Rate of development of COVID-19 in the study patient population

Time: 1 year

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Description: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19

Measure: Positive conjunctival sample rate in patient developed COVID-19

Time: 1 year

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Primary Outcomes

Description: Time it takes to identify eligible donors whom are willing to donate

Measure: Plasma Donor

Time: Measured in days for 365 days

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Description: 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 days

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Description: Time from consent to infusion

Measure: Plasma Recipient

Time: Measured evey 24 hours up to 30 days

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Description: Survival

Measure: Plasma Recipient

Time: Measured in days with 30 day from discharge follow-up

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Secondary Outcomes

Description: Time until plasma is donated

Measure: Plasma Donor

Time: Measured every 24 hours up to 1 year

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Description: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

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Description: Morbidity reduction

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

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Description: Reduced Length of Stay in hospital

Measure: Plasma Recipient

Time: Measured every 24 hours until patient discharged from hospital up to 1 year

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Description: Reduced Length of Stay on Advance Respiratory Support

Measure: Plasma Recipient

Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 year

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Primary Outcomes

Measure: seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens

Time: 12 months

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Secondary Outcomes

Measure: the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens

Time: 12 months

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Measure: the property of IgM and IgA antibody titers against the nucleocapsid protein of SARS-CoV-2 in symptomatic as well as asymptomatic COVID-19 infections over the course of time following an infection

Time: 12 months

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Measure: the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections

Time: 12 months

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Primary Outcomes

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 days

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Secondary Outcomes

Description: 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 days

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Description: 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 days

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Description: 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 days

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Description: 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 days

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Description: 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 days

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Primary Outcomes

Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

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Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

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Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (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 administration

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Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (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 administration

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Secondary Outcomes

Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

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Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

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Description: 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, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

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Description: Functional antibody responses at 7±1 days, 21±2 days, 29±3 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 administration

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Description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 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 administration

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Description: 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, 29±3 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 administration

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Primary Outcomes

Description: days of ICU stay

Measure: Length of ICU stay

Time: up to 60 days

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Secondary Outcomes

Description: days of hospital stay

Measure: Length of hospital stay

Time: up to 90 days

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Primary Outcomes

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 days

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Secondary Outcomes

Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: Severity of all symptoms

Time: 1-14 days or until the participant reports that they are well

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Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: The length of time for individual symptoms to resolve

Time: 1-14 days or until the participant reports that they are well

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Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: Severity of individual symptoms

Time: 1-14 days or until the participant reports that they are well

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Description: 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 well

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Description: Number of participants and frequency of contacts

Measure: Participants needing GP appointments

Time: 1-14 days or until the participant reports that they are well

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Description: Number of participants

Measure: Participants attending hospital

Time: 1-14 days or until the participant reports that they are well

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Description: Number of days

Measure: Length of stay in hospital if admitted

Time: 1-14 days or until the participant reports that they are well

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Description: 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 well

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Description: 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 well

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Description: 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 well

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Description: 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 well

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Description: 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 well

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Primary Outcomes

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 days

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Secondary Outcomes

Description: Mortality 28 days after randomization

Measure: Mortality 28 days after randomization

Time: 28 days

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Primary Outcomes

Description: Body Mass Index evolution from baseline

Measure: Body Mass Index

Time: 1 Month

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Description: Body Mass Index evolution from baseline

Measure: Body Mass Index

Time: 3 Months

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Secondary Outcomes

Description: Usual weight at baseline vs weight before confinement (gk)

Measure: Weight changes during confinement

Time: 8 weeks

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Description: number and type of nutritional supplements from baseline

Measure: prescription of nutritional supplements and observance

Time: 3 months

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Primary Outcomes

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 31/12/2020

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Secondary Outcomes

Description: 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 31/12/2020

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Primary Outcomes

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 8

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Description: 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 8

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Secondary Outcomes

Description: 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 8

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Description: 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 8

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Description: 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 4

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Description: 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 4

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Description: 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 14

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Description: 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 14

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Description: 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 8

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Primary Outcomes

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 months

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Secondary Outcomes

Description: Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.

Measure: Virus charge cuantification

Time: 2 months

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Description: Determine the most frequent location of viruses inPPE

Measure: Place in PPE contamination

Time: 2 month

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Other Outcomes

Description: using the information found, carry out tips to reduce the risk of contagion

Measure: Prevention risk advice

Time: 2 month

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Primary Outcomes

Description: Incidence of ≥ Grade 3 acute GvHD; or Grade 2 acute GvHD persisting beyond 14 days.

Measure: Graft versus Host Disease (GvHD)

Time: 14 days post infusion or until treatment toxicity resolves

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Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any dose level or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 CRS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.

Measure: Cytokine Release Syndrome (CRS)

Time: 14 days post infusion or until treatment toxicity resolves

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Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any DL or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 ICANS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.

Measure: Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Time: 14 days or until treatment toxicity resolves

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Description: Incidence of any ≥ Grade 3 adverse event related to the T cell product [Treatment-related adverse events (tAE)] within 14 days of the VST infusion and not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.

Measure: Adverse Events

Time: 14 days post infusion or until treatment toxicity resolves

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Description: Randomized Trial: Record the daily measurement of clinical response using the WHO Ordinal scale [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged. The proportion of patients in the treatment arm will be compared to the control arm who have a clinical response by day 7 post-randomization (measured by a decrease in 2 or more points on the WHO scale)

Measure: Clinical Response Assessment: World Health Organization (WHO) Ordinal Scale

Time: 7 Days or at time of hospital discharge

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Primary Outcomes

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 study

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Secondary Outcomes

Description: 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 study

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Primary Outcomes

Measure: Changes in cytokines associated with SARS CoV-2 infection

Time: 1 month

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Measure: Evaluation of cellular response

Time: 1 month

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Measure: TLRs activation

Time: 1 month

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Measure: KIR phenotype determination

Time: 1 month

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Primary Outcomes

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)

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Measure: Proportion of participants who died due to COVID-19 progression and/ or complications

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

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Secondary Outcomes

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 randomization

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Description: 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 randomization

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Description: 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 randomization

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Description: Proportion of participants with hospitalization for any cause

Measure: Hospitalization for any cause

Time: Measuring during 28-day period since randomization

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Measure: Proportion of participants who died due to pulmonary complications

Time: Measuring during 28-day period since randomization

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Measure: Proportion of participants who died due to cardiovascular complications

Time: Measuring during 28-day period since randomization

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Description: 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 randomization

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Description: 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 randomization

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Measure: proportion of non-adherent participants to any of study drugs

Time: Measuring during 10-day period since randomization

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Primary Outcomes

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 initiation

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Secondary Outcomes

Description: 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 infusion

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Primary Outcomes

Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load

Measure: Change in SARS-Cov-2 viral load

Time: Baseline to 4 weeks

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Secondary Outcomes

Description: 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 weeks

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Description: Change in healthcare utilization and hospitalization

Measure: Change in healthcare utilization and hospitalization

Time: Baseline to 4 weeks

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Other Outcomes

Description: 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 weeks

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Description: 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 weeks

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Description: 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 weeks

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Primary Outcomes

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 weeks

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Secondary Outcomes

Description: 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 weeks

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Description: Descriptive assessment of clinical parameters and LUS-score over time

Measure: Association of LUS to clinical parameters

Time: 3 weeks

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Description: 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 weeks

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Primary Outcomes

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)

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Secondary Outcomes

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)

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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)

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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)

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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)

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Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

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Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

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Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

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Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

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Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

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Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

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Primary Outcomes

Description: The proper knowledge about covid-19

Measure: The number of pregnant women who have knowledge about covid-19

Time: one month

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Primary Outcomes

Description: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

Measure: COVID-19 associated immune disorder

Time: 24 hours

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Description: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

Measure: COVID-19 associated inflammation

Time: 48 hours

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Description: Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)

Measure: Oxygenation

Time: 24 hours

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Description: SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab

Measure: Diagnostic of COVID disease composite

Time: On admission of hospital

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Secondary Outcomes

Description: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

Measure: Changes at the cytokine pattern

Time: 14 Days

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Description: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

Measure: Changes at circulating immune cell composition

Time: 14 Days

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Description: Proportion of patients with Intensive Care Unit Admission requirement

Measure: Intensive Care Unit Admission

Time: Day 7-14

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Description: Days of Hospitalization

Measure: Length of hospital stay

Time: Day 7-14

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Description: Clinical status assessed according to the World Health Organization guideline

Measure: Clinical Status

Time: Day 7-14

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Description: Proportion of death patients at days

Measure: Mortality

Time: Day 7-14

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Primary Outcomes

Description: vaccine events such as fever, rash, abnormal vital signs

Measure: frequency of vaccine events

Time: day 0 to day 28

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Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response

Measure: Proportion of subjects with positive T-cell response

Time: day 0 to 1 year

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Description: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B

Measure: Proportion of subjects able to suppress viral propagation

Time: day 0 to 1 year

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Primary Outcomes

Description: Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)

Measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab

Time: From baseline to day 29

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Secondary Outcomes

Description: Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale

Measure: Improvement in clinical severity score (a)

Time: Baseline, days 7, 15, 21, 29

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Description: Defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital, whichever comes first

Measure: Improvement in clinical severity score (b)

Time: Baseline, days 7, 15, 21, 29

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Measure: Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial

Time: From baseline to day 29

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Measure: Oxygenation free days in the first 28 days

Time: From baseline to day 29

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Measure: Ventilator free days in the first 28 days

Time: From baseline to day 29

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Measure: Incidence of new mechanical ventilation use during the trial

Time: From baseline to day 29

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Measure: Number of patients transferred to Intensive Care Unit (ICU)

Time: From baseline to day 29

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Measure: Mortality rate

Time: From baseline to day 29

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Description: Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)

Measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score

Time: Baseline, day 21; extra follow up at 90 days

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Measure: Duration of hospital stay expressed in days

Time: From baseline to day 29

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Measure: Viral load measured on plasma with RT-PCR

Time: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29

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Other Outcomes

Measure: Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG)

Time: Baseline, day 15

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Measure: Antibodies to SARS-CoV-2

Time: Baseline, days 7, 15, 29

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Measure: Antibodies to IFN-β1a

Time: Baseline, days 7, 15, 29

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Primary Outcomes

Description: To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada

Measure: Cumulative Incidence of COVID-19

Time: 12 months

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Secondary Outcomes

Description: To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions

Measure: Risk Factors for COVID-19

Time: 12 months

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Description: To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.

Measure: Parent-reported probable case definition of COVID-19

Time: 12 months

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Description: To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.

Measure: Dynamics of COVID-19

Time: 12 months

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Description: To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.

Measure: Risk to family members

Time: 12 months

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Description: To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents

Measure: Severity of COVID-19

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health

Measure: Longer term effects of COVID-19 on physical health

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health

Measure: Longer term effects of COVID-19 on mental health

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on child development

Measure: Longer term effects of COVID-19 on child development

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning

Measure: Longer term effects of COVID-19 on family functioning

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours

Measure: Longer term effects of COVID-19 on health behaviours

Time: 12 months

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Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization

Measure: Longer term effects of COVID-19 on healthcare utilization

Time: 12 months

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Description: To determine the effect of preventive measures on COVID-19 infection

Measure: Effects of preventive measures on infection

Time: 12 months

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Description: To determine the effect of preventive measures on physical health

Measure: Effects of preventive measures on physical health

Time: 12 months

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Description: To determine the effect of preventive measures on mental health

Measure: Effects of preventive measures on mental health

Time: 12 months

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Description: To determine the effect of preventive measures on child development

Measure: Effects of preventive measures on child development

Time: 12 months

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Description: To determine the effect of preventive measures on family functioning

Measure: Effects of preventive measures on family functioning

Time: 12 months

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Description: To determine the effect of preventive measures on health behaviours

Measure: Effects of preventive measures on health behaviours

Time: 12 months

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Description: To determine the effect of preventive measures on healthcare utilization

Measure: Effects of preventive measures on healthcare utilization

Time: 12 months

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Primary Outcomes

Description: Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín). Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.

Measure: Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th.

Time: 7 day

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Secondary Outcomes

Description: Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.

Measure: Comparative decrease of the viral load

Time: 3 - 35 days

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Description: Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)

Measure: Clinical improvement

Time: 1 - 35 days

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Description: Percentage of pneumonia patients meeting severity criteria.

Measure: Pneumonia patients meeting severity criteria.

Time: 1 - 35 days

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Description: Number of days with fever (axillary temperature higher than 37.5°C).

Measure: Number of days with fever

Time: 1 - 35 days

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Other Outcomes

Description: Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.

Measure: Patients requiring mechanical ventilation

Time: 1 - 35 days

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Description: Mortality rate.

Measure: Mortality rate.

Time: 1- 35 days

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Description: Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).

Measure: Lymphocyte recovery

Time: 7 day

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Description: Days of ICU hospitalization.

Measure: ICU hospitalization.

Time: 1 - 35 days

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Description: Oxygen saturation (SpO2) > 92% (at ambient FiO2).

Measure: Oxygen saturation

Time: 1 - 35 days

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Description: Days of hospitalization

Measure: Days of hospitalization

Time: 1 - 35 days

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Description: Respiratory rate per minute (in afebrile state conditions).

Measure: Respiratory rate

Time: 1 - 35 days

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Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.

Measure: Survival without needs of ventilator utilization at day 14

Time: day 14

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Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale at day 7 and 14

Time: day 7 and day 14

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Description: Overall survival

Measure: Overall survival at 14, 28, 60 and 90 days

Time: 14, 28, 60 and 90 days

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Description: Cumulative incidence of discharge alive

Measure: Cumulative incidence of discharge alive at 14 and 28 days

Time: 14 and 28 days

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Description: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of mechanical ventilation at day 1

Time: day 1

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Description: Cumulative incidence of oxygen supply independency

Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days

Time: 14 and 28 days

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Primary Outcomes

Description: Postbariatric surgery COVID-19 infection, mortality and complications

Measure: Postoperative COVID-19 infection

Time: 30 postoperative days

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Secondary Outcomes

Description: Complications, reoperations for any reason related to bariatric surgery.

Measure: Complications related to bariatric surgery

Time: 30 postoperative days

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Primary Outcomes

Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

Time: First dose date up to Day 30 Follow-up Assessment

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Description: This will be assessed at various time points by clinical laboratory tests and vital signs.

Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities

Time: First dose date up to Day 30 Follow-up Assessment

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Secondary Outcomes

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.

Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum

Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734

Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734

Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞)

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.

Measure: Half-Life (t1/2) - Pharmacokinetic Assessment

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.

Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment

Time: 7 days

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Description: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.

Measure: Clearance [CL] - Pharmacokinetic Assessment

Time: 7 days

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