Primary Outcomes

Description: evaluate the levels of the activation of T cells and myeloid cells after phenelzine exposure by the levels of the % of DR+ CD38+ T cells and CD14+dim CD16+ monocytes.

Measure: levels of lymphocytes T DR + CD38 + and of monocytes CD14 dim + CD16 +.

Time: through study completion, an average of 1 year

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Secondary Outcomes

Description: evaluate the levels of the expression of immune checkpoints on T cells by flow cytometry

Measure: level of immune checkpoints

Time: through study completion, an average of 1 year

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Description: evaluate the modification of functional capacities of T cells by cytokines production, and proliferation, after mitogenic and antigen recall stimulations including SARS-CoV-2 antigens

Measure: cytokine production and proliferation

Time: through study completion, an average of 1 year

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Description: assess if there is an impact of phenelzine on the activation levels of neutrophils

Measure: levels of neutrophils

Time: through study completion, an average of 1 year

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Description: Determine if the immune responses in obese patients (a strong risk factor for severe Covid19) can be modulated in the same way compared with lean patients

Measure: level of immune responses in obese patients

Time: through study completion, an average of 1 year

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Description: Determine if the immune responses can be modulated in the same way in men and in women (men being affected by more severe disease)

Measure: level of immune responses for men and women

Time: through study completion, an average of 1 year

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Primary Outcomes

Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.

Measure: Time to clinical worsening

Time: RCT (approximately 15 days)

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Secondary Outcomes

Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

Measure: clinical deterioration on a Likert-type scale (1-6)

Time: RCT (approximately 15 days)

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Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.

Measure: clinical deterioration measured by number of days

Time: RCT (approximately 15 days)

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Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.

Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe)

Time: RCT (approximately 15 days)

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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: Measure the number of unanticipated adverse events over the duration of the study protocol

Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects

Time: 26 Days

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Secondary Outcomes

Description: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects

Time: Day 5,12,19 and 26

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Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum

Time: Day 19 and 26

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Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score

Time: Day 19 and 26

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Other Outcomes

Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions

Time: Day 26

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Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

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Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

Measure: Antiviral effect

Time: Day 26

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Description: Time to clinical recovery as measured by resolution of clinical signs

Measure: Efficacy on clinical improvement

Time: Day 26

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Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

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Primary Outcomes

Description: Removal of all oxygen support (with stable SpO2)

Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

Time: by Day 28

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Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

Time: Day 14

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Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

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Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

Time: by Day 21

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Measure: Time (in days) to RTRA (main study)

Time: Days 10, 14, 21, 28

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Measure: Percent of subjects who achieve clinical stability (main study)

Time: by Day 28

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Measure: Percent of subjects discharged (without mortality and hospice) (main study)

Time: by Days 14, 21, 28 and 35

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Measure: Time (in days) to first hospital discharge (without hospice) (main study)

Time: through Day 35

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Measure: Total number of inpatient days (main study)

Time: up to Day 35

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Measure: Baseline SAD-RV infection-related mortality rate (main study)

Time: at Day 28

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Measure: Baseline SAD-RV infection-related mortality rate (main study)

Time: at Day 35

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Measure: All-cause mortality rate (main study)

Time: at Day 35

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Measure: Change in pulmonary function (FEV1% predicted) (main study)

Time: Day 1, Day 7, Day 14, Day 28

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Measure: Time to improved COVID19 clinical status (Sub-study)

Time: Day 5, Day 10, Day 21, Day 28

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Measure: Time to RTRA

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

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Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

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Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

Time: Day 5, Day 10, Day 14, Day 21, Day 28

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Measure: Time to Clinical deterioration

Time: Day 5, Day 10, Day 14, Day 21, Day 28

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Measure: Time to Discharge from hospital (without readmission before Day 28).

Time: Day 14, Day 21, Day 28

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Measure: Time to Death (all causes)

Time: Day 14, Day 21, Day 28

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Primary Outcomes

Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Time: within 6 weeks (42 days)

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Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Time: 4 weeks (28 days) post-delivery

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Secondary Outcomes

Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.

Measure: Incidence of chorioamnionitis

Time: prior to delivery

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Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.

Measure: Incidence of endometritis

Time: within 42 days post-delivery

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Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).

Measure: Incidence of other infections

Time: within 42 days post-delivery

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Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.

Measure: Incidence of use of subsequent maternal antibiotic therapy

Time: after randomization to 42 days post-delivery

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Description: Time from drug administration until initial discharge after delivery (time may vary by site).

Measure: Maternal initial hospital length of stay

Time: within 42 days post-delivery

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Description: Maternal readmissions within 42 days of delivery

Measure: Incidence of maternal readmissions

Time: within 42 days post-delivery

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Description: Maternal admission to special care units

Measure: Incidence of maternal admission to special care units

Time: within 42 days post-delivery

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Description: Maternal unscheduled visit for care

Measure: Incidence of maternal unscheduled visit for care

Time: within 42 days post-delivery

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Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.

Measure: Incidence of maternal GI symptoms

Time: within 42 days post-delivery

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Description: Maternal death due to sepsis using the Global Network algorithm for cause of death

Measure: Incidence of maternal death due to sepsis

Time: within 42 days post-delivery

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Description: Incidence of other neonatal infections.

Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection)

Time: within 42 days post-delivery

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Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).

Measure: Neonatal initial hospital length of stay

Time: within 28 days of delivery

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Description: Neonatal readmissions within 42 days of delivery

Measure: Incidence of neonatal readmissions

Time: within 42 days of delivery

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Description: Neonatal admission to special care units

Measure: Incidence of neonatal admission to special care units

Time: within 28 days of delivery

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Description: Neonatal unscheduled visit for care

Measure: Incidence of neonatal unscheduled visit for care

Time: within 42 days post-delivery

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Description: Neonatal death due to sepsis using the Global Network algorithm for causes of death

Measure: Incidence of neonatal death due to sepsis

Time: within 28 days of delivery

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Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.

Measure: Incidence of pyloric stenosis within 42 days of delivery

Time: within 42 days of delivery

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Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

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Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

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Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

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Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

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Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

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Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years

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Primary Outcomes

Description: Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios

Measure: Performance of the novel pathogen detection assay

Time: 3 years

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Secondary Outcomes

Description: Time to reportable test results

Measure: Time to results

Time: 3 years

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Description: Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?

Measure: Negative cultures

Time: 3 years

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Description: Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission

Measure: Antibiotic therapy

Time: 3 years

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Description: Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without

Measure: Prevalence of COVID19 in children admitted to PICU

Time: 2 years

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Primary Outcomes

Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 7 days after randomization

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Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 14 days after randomization

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Secondary Outcomes

Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 7 days after randomization

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Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 7 days after randomization

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Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 7 days after randomization

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Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 14 days after randomization

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Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 14 days after randomization

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Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 14 days after randomization

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Description: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract

Measure: Clearance of noval coronavirus

Time: 14 days after randomization

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Description: All-cause mortality

Measure: All-cause mortality

Time: 30 days after randomization

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