Covid 19 Research using Clinical Trials (Home Page)
Standard of CareWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (23)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug590 | Interferon-Beta Wiki | 0.30 |
| drug1204 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.30 |
| drug84 | Ascorbic Acid and Zinc Gluconate Wiki | 0.30 |
| drug311 | Convalescent Plasma 1 Unit Wiki | 0.30 |
| drug980 | Ruxolitinib plus simvastatin Wiki | 0.30 |
| drug502 | Hydoxychloroquine or Chloroquine Wiki | 0.30 |
| drug228 | COVSurf Drug Delivery System Wiki | 0.30 |
| drug312 | Convalescent Plasma 2 Units Wiki | 0.30 |
| drug169 | Blood and derivatives. Wiki | 0.30 |
| drug432 | Favipiravir + Standard of Care Wiki | 0.30 |
| drug1257 | Zinc Gluconate Wiki | 0.30 |
| drug954 | Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) Wiki | 0.30 |
| drug626 | Lenzilumab Wiki | 0.30 |
| drug1412 | this study is non- interventional Wiki | 0.30 |
| drug809 | Oxytocin Wiki | 0.30 |
| drug1293 | convalescent plasma from recovered COVID 19 donor Wiki | 0.30 |
| drug1422 | vv-ECMO only (no cytokine adsorption) Wiki | 0.21 |
| drug1421 | vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki | 0.21 |
| drug957 | Remdesivir Wiki | 0.18 |
| drug83 | Ascorbic Acid Wiki | 0.15 |
| drug108 | Azithromycin Wiki | 0.11 |
| drug505 | Hydroxychloroquine Wiki | 0.07 |
| drug850 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000257 | Adenoviridae Infections NIH | 0.21 |
| D012327 | RNA Virus Infections NIH | 0.15 |
| D014777 | Virus Diseases NIH | 0.13 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.13 |
| D018352 | Coronavirus Infections NIH | 0.12 |
| D012141 | Respiratory Tract Infections NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.07 |
| D007239 | Infection NIH | 0.06 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D013577 | Syndrome NIH | 0.04 |
| D055371 | Acute Lung Injury NIH | 0.04 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.07 |
| HP:0002090 | Pneumonia HPO | 0.07 |
There are 11 clinical trials
Clinical Trials
1 A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
NCT04292730 COVID-19 Drug: Remdesivir Drug: Standard of Care
Primary Outcomes
Description: The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized.
Measure: The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 Time: Day 11Secondary Outcomes
Measure: Proportion of Participants experiencing Treatment-Emergent Adverse Events Time: First dose date up to 10 days plus 30 days2 A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
NCT04292899 COVID-19 Drug: Remdesivir Drug: Standard of Care
Primary Outcomes
Description: The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized.
Measure: The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 14 Time: Day 14Secondary Outcomes
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to 10 days plus 30 days3 Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study
The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.
NCT04342728 COVID Corona Virus Infection Dietary Supplement: Ascorbic Acid Dietary Supplement: Zinc Gluconate Dietary Supplement: Ascorbic Acid and Zinc Gluconate Other: Standard of Care MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Outpatients who test positive for the Coronavirus 2019; number of days required in which they reach a 50 percent reduction in the cumulative 0-12 score symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue. Each patient will have a composite score ranging from 0-12/day
Measure: Symptom Reduction Time: 28 daysSecondary Outcomes
Description: The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6
Measure: Symptom Resolution: Fever Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe
Measure: Symptom Resolution: Cough Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities
Measure: Symptom Resolution: Shortness of Breath Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Symptom Resolution: Fatigue Time: 28 daysDescription: Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Day 5 Symptoms Time: 5 daysDescription: Differences in hospitalization events between the study arms
Measure: Hospitalizations Time: 28 daysDescription: Differences in severity of symptoms between study arms
Measure: Severity of Symptoms Time: 28 daysDescription: Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
Measure: Adjunctive Medications Time: 28 daysDescription: Differences in number of patients in study arms who experienced side effects from the supplements.
Measure: Supplementation Side Effects Time: 28 days4 Multi-center, Randomized Clinical Trial of Convalescent Plasma Therapy Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients
A total of 278 patients are planned. All patients will be in an early-stage of COVID-19. They must be adults and hospitalized. In this study, all participating patients will receive the standard treatment provided according to the current treatment protocols for coronavirus disease. In addition to this treatment, each patient will be randomly assigned to receive additional treatment with convalescent plasma transfusion (CP; blood plasma from patients who have been cured of coronavirus), or continue with standard treatment but without adding transfusion. 50% of the chances of additional treatment with CP, and 50% of the chances of receiving only the standard treatment for coronavirus. The duration of the study shall be one month from the assignment of the treatment. The patient and the doctor will know the treatment assigned.
NCT04345523 COVID-19 Other: Blood and derivatives. Drug: Standard of Care
Primary Outcomes
Description: Proportion of patients in categories 5, 6 or 7 of the 7-point ordinal scale at day 15 Ordinal scale: Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities. 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: Category Changes in Ordinal Scale Time: 15 daysSecondary Outcomes
Description: Time to change from baseline category to worsening into 5,6 or 7 categories of the ordinal scale
Measure: Time to category 5, 6 or 7 of the ordinal scale Time: 29 daysDescription: Mortality
Measure: Mortality of any cause at 15 days Time: 15 daysDescription: Mortality
Measure: Mortality of any cause at 29 days Time: 29 daysDescription: days free from oxygen supplementation
Measure: Oxygenation free days Time: 29 daysDescription: days free from mechanical ventilation
Measure: Ventilator free days Time: 29 daysDescription: Infusion-related adverse events Cumulative incidence of serious adverse events (SAEs) Cumulative incidence of Grade 3 and 4 adverse events (AEs).
Measure: Incidence of Treatment-Emergent Adverse Events Time: 29 daysDescription: Quantitative total antibodies and neutralizing antibody activity against SARSCoV-2 in the sera from donors and patients using viral pseudotypes
Measure: Antibodies levels in CP donors recovered from COVID-19 Time: 3 monthsDescription: Change in PCR for SARS-CoV-2 in naso/oropharyngeal swabs and blood at baseline and on days 3, 5, 8, 11 (while hospitalized); and days 15 and 29 (if able to return to clinic or still hospitalized).
Measure: Viral load Time: Days 1,3,5,8,11 and 29Other Outcomes
Description: Serum levels of CRP, lymphocyte count, LDH, D Dimer,IL-6, coagulation tests at baseline and days 3, 5, 8, 11, 15 and 29.
Measure: Change in biological parameters Time: Days 1,3,5,8,11 and 295 Randomized Phase II Clinical Trial of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.Ruxo-Sim-20 Clinical Trial.
COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.
NCT04348695 Coro Coronavirus Infection Drug: Ruxolitinib plus simvastatin Other: Standard of Care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency
Primary Outcomes
Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.
Measure: Percentage of patients who develop severe respiratory failure. Time: 7 daysSecondary Outcomes
Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.
Measure: Percentage of patients who develop severe respiratory failure. Time: 14 daysDescription: Time from ICU admision to ICU discharge.
Measure: Length of ICU stay. Time: 28 daysDescription: Time from hospital admision to hospital discharge.
Measure: Length of hospital stay Time: 28 daysDescription: Percentage of patients alive at 6 months
Measure: Survival rate at 6 months Time: 6 monthsDescription: Percentage of patients alive at 12 months
Measure: Survival rate at 12 months Time: 12 monthsDescription: Percentage of patients who died from any cause 28 days after inclusion in the study
Measure: Survival rate at 28 days Time: 28 daysDescription: Percentage of patients with each AE by grade in relation with total number of treated patients
Measure: Percentage of patients with each AE by grade Time: 28 daysDescription: Percentage of patients who discontinued due to AEs in relation with total number of treated patients
Measure: Percentage of patients who discontinued due to AEs Time: 28 days6 A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.
NCT04351152 Coronavirus Disease 2019 (COVID-19) Pneumonia Biological: Lenzilumab Drug: Standard of Care MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia
Primary Outcomes
Measure: Incidence of invasive mechanical ventilation (IMV) and/or Mortality Time: Up to 28 days
Secondary Outcomes
Description: Acute respiratory distress syndrome defined as new or worsening respiratory symptoms with PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315, chest imaging (radiograph, CT scan, or lung ultrasound) revealing bilateral opacities and pulmonary infiltrates not fully explained by fluid overload or cardiac failure
Measure: Incidence of acute respiratory distress syndrome (ARDS) Time: Up to 28 days
Measure: Duration of Hospitalization Time: Up to 28 days
Measure: Duration of Intensive Care Unit (ICU) Stay Time: Up to 28 days
Measure: Ventilator-free Days Time: Up to 60 days
Measure: Incidence of Non-invasive Ventilation Time: Up to 28 days
Measure: Proportion of Participants Alive and Off Oxygen Time: Up to 60 days
Description: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measure: Percentage of Participants Experiencing Adverse Events Time: Up to 60 days
Description: Using the NCI CTCAE version 5.0
Measure: Percentage of Participants Experiencing Serious Adverse Events Time: Up to 60 days
7 Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
Primary Outcomes
Measure: Incidence of invasive mechanical ventilation (IMV) and/or Mortality Time: Up to 28 daysSecondary Outcomes
Description: Acute respiratory distress syndrome defined as new or worsening respiratory symptoms with PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315, chest imaging (radiograph, CT scan, or lung ultrasound) revealing bilateral opacities and pulmonary infiltrates not fully explained by fluid overload or cardiac failure
Measure: Incidence of acute respiratory distress syndrome (ARDS) Time: Up to 28 daysMeasure: Duration of Hospitalization Time: Up to 28 days
Measure: Duration of Intensive Care Unit (ICU) Stay Time: Up to 28 days
Measure: Ventilator-free Days Time: Up to 60 days
Measure: Incidence of Non-invasive Ventilation Time: Up to 28 days
Measure: Proportion of Participants Alive and Off Oxygen Time: Up to 60 days
Description: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measure: Percentage of Participants Experiencing Adverse Events Time: Up to 60 daysDescription: Using the NCI CTCAE version 5.0
Measure: Percentage of Participants Experiencing Serious Adverse Events Time: Up to 60 daysThe purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).
NCT04355728 Corona Virus Infection ARDS ARDS, Human Acute Respiratory Distress Syndrome COVID-19 Biological: Umbilical Cord Mesenchymal Stem Cells Other: Standard of Care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome
Primary Outcomes
Description: Safety will be defined by the incidence of pre-specified infusion associated adverse events as assessed by treating physician
Measure: Incidence of pre-specified infusion associated adverse events Time: Day 5Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician
Measure: Incidence of Severe Adverse Events Time: 90 daysSecondary Outcomes
Description: Number of participants that are alive at 90 days post first infusion follow up.
Measure: Survival rate after 90 days post first infusion Time: 90 daysDescription: Number of days participants were off ventilators within up to 28 days of hospitalization
Measure: Ventilator-Free Days Time: 28 days or hospital discharge, whichever is earlierDescription: Measure the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).
Measure: Change in Oxygenation Index (OI) Time: 28 daysDescription: Measuring respiratory mechanics in ventilated patients [plateau pressure (Pplat)-positive end-expiratory pressure]
Measure: Plat-PEEP Time: 28 daysDescription: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure)
Measure: Sequential Organ Failure Assessment (SOFA) Scores Time: 28 daysDescription: The SIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The test has a total score ranging from 0-40 Follows scoring key for evaluation. The higher score indicates better outcome.
Measure: Small Identification Test (SIT) scores Time: At baseline, day 18 and day 28.Description: As assessed via serum blood samples.
Measure: Troponin I levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: C-Reactive Protein levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Arachidonic Acid (AA)/Eicosapentaenoic Acid (EPA) Ratio Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: D-dimer levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: 25-Hydroxy Vitamin D levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Alloantibodies levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Blood white cell count Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Platelets count Time: Baseline, 28 days8 Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir v. Standard of Care in Hospitalized Subjects With COVID-19
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
NCT04358549 COVID-19 Drug: Favipiravir + Standard of Care Drug: Standard of Care
Primary Outcomes
Description: To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling
Measure: Time to viral clearance Time: Day 29Secondary Outcomes
Description: To determine the clinical benefit of administering favipiravir plus SOC compared to SOC alone, clinical benefit will be measured using a study-specified ordinal scale on Day 15 in adult patients hospitalized with COVID-19.
Measure: Status of clinical recovery as measured by the study-specific 6-point ordinal scale on Day 15 Time: through Day 15Description: The NEWS is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to, or are being monitored in hospital. Six simple physiological parameters form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, temperature.
Measure: Clinical effect of favipiravir + SOC compared to SOC measured by the National Early Warning Score 2 (NEWS2) Time: through Day 29Description: Measurement of maximum plasma concentration
Measure: Characterize the pharmacokinetics (PK) of favipiravir in plasma: Cmax) Time: through Day 14Description: Measurement of minimum plasma concentration
Measure: Characterized the pharmacokinetics (PK) of favipiravir in plasma: Cmin Time: through Day 14Description: Measurement of the area under the curve of plasma concentration versus time profile
Measure: Characterized the pharmacokinetics (PK) of favipiravir in plasma: AUC Time: through Day 149 A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19
Lung surfactant is present in the lungs. It covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. In some respiratory diseases and in patients that require ventilation this substance does not function normally. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System
NCT04362059 Respiratory Infections Device: COVSurf Drug Delivery System Other: Standard of Care MeSH:Respiratory Tract Infections
HPO:Respiratory tract infection
Primary Outcomes
Description: To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment
Measure: Oxygenation Improvement Time: 3 months
Description: To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP − PEEP) × PaCO2]/1000 after study treatment.
Measure: Pulmonary ventilation Improvement Time: 3 months
Secondary Outcomes
Description: To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).
Measure: Safety Assessment of Frequency and Severity of Adverse Events Time: 3 months
10 Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma
Primary Outcomes
Description: To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment
Measure: Oxygenation Improvement Time: 3 monthsDescription: To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP − PEEP) × PaCO2]/1000 after study treatment.
Measure: Pulmonary ventilation Improvement Time: 3 monthsSecondary Outcomes
Description: To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).
Measure: Safety Assessment of Frequency and Severity of Adverse Events Time: 3 monthsThis is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
NCT04376034 COVID19 Coronavirus Infection Coronavirus Virus Diseases RNA Virus Infections Biological: Convalescent Plasma 1 Unit Biological: Convalescent Plasma 2 Units Other: Standard of Care MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Virus Diseases
Primary Outcomes
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upSecondary Outcomes
Description: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 year11 Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19
Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
NCT04386447 Covid-19 Corona Virus Infection SARS-CoV 2 Drug: Oxytocin Drug: Standard of Care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
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 daysSecondary Outcomes
Description: Mortality 28 days after randomization
Measure: Mortality 28 days after randomization Time: 28 days