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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug103 | ARCT-021 Dose Regimen 1 Wiki | 0.16 |
| drug3647 | Video Visit Wiki | 0.16 |
| drug2266 | Novel laser inferometry test for CORONA virus Wiki | 0.16 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug549 | Brequinar Wiki | 0.16 |
| drug1026 | Desidustat Wiki | 0.16 |
| drug1123 | EG-HPCP-03a Wiki | 0.16 |
| drug3394 | Telehealth phone calls Wiki | 0.16 |
| drug2757 | Quetiapine Wiki | 0.16 |
| drug898 | Convalescent Plasma 1 Unit Wiki | 0.16 |
| drug106 | ARFC mask Wiki | 0.16 |
| drug100 | ARCT-021 Dose 2 Wiki | 0.16 |
| drug1266 | Extracorporeal membrane oxygenation Wiki | 0.16 |
| drug116 | ASTX660 Wiki | 0.16 |
| drug3752 | Zinc Gluconate Wiki | 0.16 |
| drug227 | Ampion Wiki | 0.16 |
| drug276 | Antioxidation Therapy Wiki | 0.16 |
| drug3978 | mouthrinse with bêta-cyclodextrin and citrox Wiki | 0.16 |
| drug2773 | RESP301, a Nitric Oxide generating solution Wiki | 0.16 |
| drug1124 | EG-HPCP-03a Placebo Wiki | 0.16 |
| drug899 | Convalescent Plasma 2 Units Wiki | 0.16 |
| drug3627 | Valproate Wiki | 0.16 |
| drug507 | Blood and derivatives. Wiki | 0.16 |
| drug3525 | Transpulmonary thermodilution Wiki | 0.16 |
| drug2456 | Pegylated Interferon-α2b Wiki | 0.16 |
| drug3687 | Volunteer of TIP-OA Program Wiki | 0.16 |
| drug3979 | mouthrinse without bêta-cyclodextrin and citrox Wiki | 0.16 |
| drug3898 | high flow nasal cannula device Wiki | 0.16 |
| drug1487 | High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki | 0.16 |
| drug2090 | Montelukast Oral Granules Wiki | 0.16 |
| drug2935 | Ruxolitinib plus simvastatin Wiki | 0.16 |
| drug2989 | SCTA01 Wiki | 0.16 |
| drug3098 | Serological test for COVID-19. Wiki | 0.16 |
| drug305 | Ascorbic Acid and Zinc Gluconate Wiki | 0.16 |
| drug102 | ARCT-021 Dose 4 Wiki | 0.16 |
| drug3188 | Stakeholder of TIP-OA Program Wiki | 0.16 |
| drug3162 | Sodium bicarbonate Wiki | 0.16 |
| drug1834 | LifeSignals Biosensor 1AX* Wiki | 0.16 |
| drug3204 | Standard Plasma (FFP) Wiki | 0.16 |
| drug152 | Abivertinib Wiki | 0.16 |
| drug2945 | SARS-CoV-2 Ab Wiki | 0.16 |
| drug1628 | Imatinib Mesylate Wiki | 0.16 |
| drug3671 | Vit D Wiki | 0.16 |
| drug104 | ARCT-021 Dose Regimen 2 Wiki | 0.16 |
| drug781 | Chloroquine diphosphate Wiki | 0.16 |
| drug616 | COVI-GUARD Wiki | 0.16 |
| drug921 | Core Warming Wiki | 0.16 |
| drug3354 | TERA Intervention Wiki | 0.16 |
| drug101 | ARCT-021 Dose 3 Wiki | 0.16 |
| drug679 | COVSurf Drug Delivery System Wiki | 0.16 |
| drug1302 | Favipiravir + Standard of Care Wiki | 0.16 |
| drug2867 | Renin-angiotensin system inhibitors Wiki | 0.16 |
| drug2198 | Nitazoxanide and atazanavir/ritonavir Wiki | 0.16 |
| drug2660 | Prolectin-M; a (1-6)-alpha-D-Mannopyranose class Wiki | 0.16 |
| drug2896 | Rifaximin Novel Formulation Wiki | 0.16 |
| drug99 | ARCT-021 Dose 1 Wiki | 0.16 |
| drug1709 | Intervention group CoronaCope Wiki | 0.16 |
| drug2366 | Oxytocin Wiki | 0.16 |
| drug3236 | Standard of care management Wiki | 0.16 |
| drug3268 | Stellate Ganglion Block Wiki | 0.12 |
| drug482 | Biological sample collection Wiki | 0.12 |
| drug246 | Angiotensin II Wiki | 0.12 |
| drug1822 | Lenzilumab Wiki | 0.12 |
| drug1582 | Hypothermia Wiki | 0.12 |
| drug2176 | Neuromuscular Blocking Agents Wiki | 0.12 |
| drug1744 | Itraconazole Wiki | 0.09 |
| drug1150 | Echocardiography Wiki | 0.09 |
| drug2146 | Nafamostat Mesilate Wiki | 0.09 |
| drug2680 | Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki | 0.09 |
| drug2337 | Opaganib Wiki | 0.08 |
| drug304 | Ascorbic Acid Wiki | 0.08 |
| drug632 | COVID-19 Convalescent Plasma Wiki | 0.07 |
| drug2044 | Midazolam Wiki | 0.07 |
| drug1296 | Favipiravir Wiki | 0.07 |
| drug2855 | Remdesivir Wiki | 0.07 |
| drug895 | Convalescent Plasma Wiki | 0.06 |
| drug717 | Camostat Mesilate Wiki | 0.06 |
| drug2931 | Ruxolitinib Wiki | 0.05 |
| drug1030 | Dexamethasone Wiki | 0.05 |
| drug1196 | Enoxaparin Wiki | 0.04 |
| drug2215 | No intervention Wiki | 0.04 |
| drug2505 | Placebo Wiki | 0.03 |
| drug3485 | Tocilizumab Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012772 | Shock, Septic NIH | 0.12 |
| D045888 | Ganglion Cysts NIH | 0.12 |
| D007035 | Hypothermia NIH | 0.12 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018352 | Coronavirus Infections NIH | 0.11 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.10 |
| D018754 | Ventricular Dysfunction NIH | 0.09 |
| D002647 | Chilblains NIH | 0.09 |
| D018487 | Ventricular Dysfunction, Left NIH | 0.09 |
| D001249 | Asthma NIH | 0.08 |
| D003693 | Delirium NIH | 0.07 |
| D058186 | Acute Kidney Injury NIH | 0.07 |
| D012769 | Shock, NIH | 0.07 |
| D012327 | RNA Virus Infections NIH | 0.07 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.06 |
| D011014 | Pneumonia NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.05 |
| D013577 | Syndrome NIH | 0.05 |
| D060825 | Cognitive Dysfunction NIH | 0.05 |
| D015658 | HIV Infections NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.04 |
| D014777 | Virus Diseases NIH | 0.04 |
| D002318 | Cardiovascular Diseases NIH | 0.03 |
| D014947 | Wounds and Injuries NIH | 0.03 |
| D012141 | Respiratory Tract Infections NIH | 0.03 |
| D001008 | Anxiety Disorders NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.02 |
| D003863 | Depression, NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002045 | Hypothermia HPO | 0.16 |
| HP:0002099 | Asthma HPO | 0.08 |
| HP:0002090 | Pneumonia HPO | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.03 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.03 |
Navigate: Correlations HPO
There are 37 clinical trials
Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.
Description: Participants with HIV-1 RNA < 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measure: Proportion of participants with plasma Human Immunodeficiency Virus - Type I ribonucleic acid (HIV-1 RNA) levels less than (<) 50 copies/mL at week 12 Time: 12 weeks post enrollmentDescription: Participants with HIV-1 RNA < 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week 12 window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at week 12 Time: 12 weeks post enrollmentDescription: Participants with HIV-1 RNA < 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 50 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 50 copies/mL at weeks 24, 36 and 48 Time: 24, 36 and 48 weeks post enrollmentDescription: Participants with HIV-1 RNA < 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA >= 200 copies/ml or with no HIV-1 RNA measurement within the week window are classified as failures.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at weeks 24, 36 and 48 Time: 24, 36 and 48 weeks post enrollmentDescription: Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are < 200 copies/ml and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is < 200 copies/ml. Otherwise the participant is classified as a failure.
Measure: Proportion of participants with HIV-1 RNA < 200 copies/mL at 12 weeks and maintained through 48 weeks Time: 24, 36 and 48 weeks post enrollmentDescription: For each participant, the percentage of days in each 7-day period in which all doses were taken is calculated, and then averaged across the 12 week interval (or number of weeks with available data).
Measure: Percent of days with all doses taken per week from weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksDescription: For each participant, the percentage of days in each 7-day period in which all doses were taken within the defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) is calculated, and then averaged across the 12 week interval (or number of weeks with available data).
Measure: Percent of days with all doses taken within defined acceptable windows (within 4 hours for once/day ART and within 2 hours for twice/day ART) per week from weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksDescription: For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of gaps between doses of >7 consecutive days relative to the number of days with data reported, times 100. Consecutive gaps of more than 7 days increase the gap count by one, e.g. missing 20 days counts as 2 gaps.
Measure: Incidence rate (per 100 days) of gaps between dosing of at least 7 consecutive days between weeks 0-12, 12-24, 24-36 and 36-48 Time: Enrollment through 48 weeksAcute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the investigators sought to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. The investigators are scheduled to begin enrolling in a Department of Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients with ARDS with time on ventilator as the primary outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study to examine the safety and feasibility of including patients with COVID-19-associated ARDS in our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and maintaining the target temperature. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2, 3, 4, and 7.
Description: The total time in hours from beginning of cooling to beginning of rewarming during which the patient's core temperature was within the target range of 34-35°C.
Measure: Targeted temperature compliance Time: Randomization through day 3Description: Adverse events expected during cooling, including hemorrhage, bradycardia, and hypotension.
Measure: Adverse event Time: Randomization through study day 3Description: Total number of days alive and not admitted to the ICU in the first 28 days after
Measure: 28-day ICU-free days Time: Calculated at study day 28 or death (whichever occurs first)Description: 28-day, 60-day, and 90-day mortality
Measure: Survival Time: calculated at 28, 60, and 90 daysDescription: SOFA score excluding neurologic component - based on PaO2/FiO2 (0-4), BP and pressor requirement (0-4), bilirubin level (0-4), platelet count (0-4), and creatinine (0-14) with total composite score 0-20
Measure: non neurologic Sequential Organ Failure (SOFA) scores Time: At enrollment and study days 1, 2, 3, 4, 7, and 28Description: Pulse ox reading
Measure: Oxygen saturation (SpO2) Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, 7 and 28Description: On machine initiated breath
Measure: Plateau airway pressure Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs firstDescription: Direct ventilator measurement on machine initiated breath
Measure: Mean airway pressure Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs firstDescription: Plateau pressure - PEEP (machine initiated breath)
Measure: Airway driving pressure Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs firstDescription: Mean airway pressure x 100 x FiO2/SpO2
Measure: Oxygen saturation index Time: Measured at enrollment, every 4 hours on enrollment day, then once on day 2, 3, 4, and 7 or until extubation whichever occurs firstDescription: Measured continuously from iv catheter, urinary catheter, or esophageal probe.
Measure: Core temperature Time: Measured continuously and recorded at enrollment, every 2 hours on the day of enrollment, and mornings on study day 2, 3, 4, and 7Description: 24 hour urine volume
Measure: Urine output Time: Daily on study day 1, 2, 3, 4, and 7Description: performed in clinical lab
Measure: comprehensive metabolic panel Time: Daily on study day 1, 2, 3, 4, and 7Description: preformed in clinical lab
Measure: Complete blood count with differential count and platelet count Time: Daily on study day 1, 2, 3, 4, and 7Description: 10 ml blood draw
Measure: Biomarkers Time: Daily on study day 1, 2, 3, 4, and 7Description: performed in clinical lab
Measure: Serum electrolytes Time: Every 8 hours until study hour 60Description: Beside blood glucose testing
Measure: Blood glucose Time: Every 4 hours until study hour 60Description: Total number of days alive and not on a ventilator in the first 28 days after enrollment
Measure: 28-day ventilator-free days Time: Calculated at study day 28 or death (whichever occurs first)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.
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 11The 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.
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 14The 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.
Description: Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day
Measure: Symptom Reduction Time: 28 daysDescription: 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: The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.
Measure: Symptom Resolution: Muscle/body aches Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.
Measure: Symptom Resolution: Headache Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.
Measure: Symptom Resolution: New loss of taste Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.
Measure: Symptom Resolution: New loss of smell Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .
Measure: Symptom Resolution: Congestion/ runny nose Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.
Measure: Symptom Resolution: Nausea Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.
Measure: Symptom Resolution: Vomiting Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.
Measure: Symptom Resolution: Diarrhea 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 daysA 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.
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 daysDescription: 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 29Description: 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 29COVID-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.
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 daysDescription: 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 daysThe primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery in hospitalized subjects with severe or critical COVID-19 pneumonia.
Description: Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).
Measure: Time to Recovery Time: Up to 28 daysDescription: 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 daysDescription: NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)
Measure: Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours Time: Up to Day 28To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
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 29Description: 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 14Lung 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
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 monthsDescription: 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.
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upDescription: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 yearIntroduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
Description: Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): respiratory failure that requires mechanical ventilation organ failure that requires intensive care monitoring and treatment death
Measure: Proportion of cases who during 14 exhibit one of the following conditions Time: 14 daysDescription: Mortality 28 days after randomization
Measure: Mortality 28 days after randomization Time: 28 daysA randomized controlled pilot study on the safety & efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
Description: Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
Measure: Primary endpoint: Disease Progression Time: 30 DaysDescription: Improvement of Hypoxic index( PaO2 / FiO2) calculated daily
Measure: Improvement in Hypoxic Index Time: From inclusion to 30 days follow upDescription: Hospital Length of stay
Measure: Hospital Length of Stay Time: From inclusion to 30 days follow upDescription: Days on mechanical ventilation for patients needing intubation & invasive mechanical ventilation
Measure: Days on invasive mechanical ventilation Time: From inclusion to 30 days follow upDescription: Difference in the median levels of serum IL-6, serum ferritin, CRP at the end of the follow up period between all groups
Measure: Inflammatory Markers Time: From inclusion to 30 daysDescription: Rate of viral clearance as monitored by SARS-COV-2 PCR
Measure: Viral clearance Time: From inclusion to 30 daysDescription: Difference in the overall evaluation of pulmonary infiltrative (improving / deteriorating) as assessed by imaging (Chest X-ray or Non-contrast pulmonary CT)
Measure: Radiological assessment Time: From inclusion to 30 daysDescription: Rate of serious adverse events (SAEs)
Measure: Safety of Imatinib Time: From inclusion to 60 daysThis will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for treatment of hospitalized patients with COVID-19 infection. In addition to SOC, the brequinar group will receive 5 daily doses of brequinar 100 mg.
Description: Adverse events are new onset medical conditions.
Measure: Safety/tolerability measured by rates of post randomization adverse events and hematology/chemistry safety labs. Time: Beginning at signing consent through Day 15.Description: In-patient hospitalization, hospitalized in ICU-level care, or discharged
Measure: Hospitalization status Time: Through Day 15Description: Duration in days from admission to discharge
Measure: Duration of hospitalization Time: Through Day 15Description: National Early Warning Score (NEWS) 2. Composite score of respiration rate, oxygen saturation, systolic blood pressure, pulse, consciousness, and temperature.
Measure: NEWS2 Score Time: Through Day 15Description: Subject mortality status
Measure: Mortality Time: Day 29Description: Nasopharyngeal viral load by RT-PCR at days 1, 3, 5, 7, and 15
Measure: SARS-CoV-2 nasopharyngeal viral load Time: Through Day 15Description: Pro-inflammatory cytokines including TNFalpha, INFgamma, IL13, IL12p70, IL10, IL8, IL6, IL4 IL2, IL1-beta and erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), D-dimer, serum ferritin, and fibrinogen
Measure: Inflammatory markers Time: Through Day 15Description: Plasma concentration of dihydroorotate
Measure: DHO Concentration Time: Through Day 15Description: Plasma concentration of brequinar
Measure: Brequinar Concentration Time: Through Day 15The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.
Description: compare the number of in-patient admissions between the monitored and non-monitored patients
Measure: Monitored versus Non-Monitored in-patient admission Time: 14 daysDescription: compare the number of Emergency Department visits
Measure: Emergency Department Visits Time: 14 daysDescription: Length of stay of subject if hospitalized
Measure: Length of stay Time: 14 daysDescription: Survey given to patient to ask about satisfaction
Measure: patient satisfaction Time: 14 daysDescription: How often does a subject end up getting mechanical ventilation or ECMO
Measure: the incidence of mechanical ventilation and ECMO Time: 14 daysDescription: events requiring extended hospital stay
Measure: serious adverse events Time: 14 daysCurrently, no effective treatments are available for the COVID-19. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID-19 patients. Investigator have recently concluded a pilot phase II open-label RCT on the efficacy of convalescent plasma in severe COVID 19 patients in which encouraging results were seen. Investigator plan to further study the efficacy and safety of convalescent plasma in COVID-19 severely sick patients through an RCT. Investigator will collect up to 500 ml Convalescent Plasma from the COVID-19 recovered persons after 14 days of clinical recovery with two consecutive SARS CoV-2 negative tests by PCR at least 24 hours apart. This plasma will be tested and frozen and stored. On requisition it will be thawed and sent to the treating center. Two doses of 250 ml convalescent plasma each will be transfused on two consecutive days to patients who fit the eligibility criteria (Severely sick COVID-19 patients) and are randomized to the convalescent plasma group along with the standard of care and the other group will receive standard of care alone. Data will be collected to study the benefits and adverse events related to convalescent plasma transfusion.
Description: The six-point scale is as follows: death=6; hospital admission for extracorporeal membrane oxygenation or mechanical ventilation=5; hospital admission for non-invasive ventilation or high-flow oxygen therapy=4; hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation)=3; hospital admission but not requiring oxygen therapy=2; discharged or having reached discharge criteria (defined as clinical recovery-ie, normalization of pyrexia, respiratory rate 94% on room air, and relief of cough, all maintained for at least 72 h)=1.
Measure: Efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier) Time: Day 28Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 0Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 3Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 7Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 14Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 21Description: IgG Titres against S1, RBD antigen, and SARS CoV2 neutralizing antibody titres
Measure: Presence of antibodies against SARS-CoV-2 in serum after plasma administration Time: Day 28Description: Serum ferritin
Measure: Change in acute phase reactants in both groups Time: Day 28The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
Description: Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10
Measure: Rate of viral elimination by Day 10 [pilot stage, dose selection] Time: 10 DaysDescription: Median time to reach undetectable SARS-CoV-2 RNA level
Measure: Time to viral elimination [pivotal stage] Time: 28 DaysDescription: Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital
Measure: Time to clinical improvement [pivotal stage] Time: 28 DaysDescription: Percent of patients with undetectable SARS-CoV-2 RNA level
Measure: Rate of viral elimination Time: Days 3, 5, 7, 9, and 11Description: Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)
Measure: Time to normalization of clinical symptoms Time: 28 DaysDescription: Mean duration of oxygen therapy [days]
Measure: Duration of oxygen therapy Time: 28 DaysDescription: Change of lung damage level according to CT comparing to baseline [% of patients]
Measure: Change in the level of lung damage according to CT Time: Days 15, 22, and 29Description: Percent of patients transferred to the intensive care unit [% of patients]
Measure: Rate of transfer to the intensive care unit Time: 28 daysDescription: Percent of patients undergoing non-invasive lung ventilation [% of patients]
Measure: Rate of the use of non-invasive lung ventilation Time: 28 daysDescription: Percent of patients undergoing mechanical ventilation [% of patients]
Measure: Rate of the use of mechanical ventilation Time: 28 daysDescription: Percent of patients died within 28-days period [% of patients]
Measure: Mortality Time: 28 daysDescription: Determination of Cmax [ng/ml]
Measure: Peak plasma concentration (Cmax) Time: Day 1Description: Determination of Tmax [h]
Measure: Time to peak plasma concentration (Tmax) Time: Day 1Description: Determination of AUC0-t [ng*h/ml]
Measure: Area under the plasma concentration versus time curve (AUC0-t) Time: 10 daysDescription: Determination of Ctrough [ng/ml]
Measure: Trough plasma concentration (Ctrough) Time: 10 daysShaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
Description: Proportion of subjects alive and free of respiratory failure at Day 14
Measure: Proportion of subjects alive and free of respiratory failure at Day 14 Time: Randomization to Day 14Description: Types, frequencies, and severities of adverse events and their relationships to STI-5656
Measure: Incidence of treatment-emergent adverse events (safety and tolerability of STI-5656) Time: Randomization through study completion to 90 daysDescription: Proportion of subjects alive and free of respiratory failure at Day 28
Measure: Proportion of subjects alive and free of respiratory failure at Day 28 Time: Randomization to Day 28Description: Change in clinical status on a 0-8-point ordinal scale (lower score means better outcome; 0=uninfected, 8=dead)
Measure: Change in clinical status Time: Randomization to Day 7, Day 14, and Day 28Description: Proportion of subjects alive and discharged from ICU at Days 14 and 28
Measure: Discharge from ICU Time: Randomization to Day 14 and Day 28Description: Time from randomization to first occurrence of respiratory failure or death on study due to any cause up to Day 28
Measure: Time to respiratory failure or death Time: Randomization to Day 28Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
Description: Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
Measure: Incidence of adverse events (safety) Time: Randomization through study completion through Day 60Description: Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
Measure: Incidence of treatment-emergent adverse events (safety) Time: Randomization through study completion through Day 60Description: Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
Measure: Incidence of serious adverse events (safety) Time: Randomization through study completion through Day 60Description: All-cause mortality at 29 and 60 days
Measure: All-cause mortality at 29 and 60 days Time: Randomization through Day 29 and Day 60Description: Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
Measure: Incidence of dose-limiting toxicities (safety) Time: Randomization through study completion through Day 60Description: Clinically meaningful laboratory abnormalities
Measure: Incidence of laboratory abnormalities (safety) Time: Randomization through study completion through Day 60Description: Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
Measure: SARS-CoV-2 viral load as assessed using various sample types Time: Randomization through study completion through Day 60Description: Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
Measure: Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital Time: Randomization up to study completion through Day 60Description: Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
Measure: Anti-drug antibodies Time: Randomization through study completion through Day 60Description: Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
Measure: Cytokine levels Time: Randomization through study completion through Day 60Description: Area under the serum concentration-time curve (AUC) of COVI-GUARD
Measure: AUC of COVI-GUARD (PK) Time: Randomization through study completion through Day 60Description: Maximum observed serum concentration (Cmax) of COVI-GUARD
Measure: Cmax of COVI-GUARD (PK) Time: Randomization through study completion through Day 60Description: Apparent serum terminal elimination half life (t½) of COVI-GUARD
Measure: t½ of COVI-GUARD (PK) Time: Randomization through study completion through Day 60Description: Time to Cmax (Tmax) of COVI-GUARD
Measure: Tmax of COVI-GUARD (PK) Time: Randomization through study completion through Day 60This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.
Description: Incidence and severity of adverse events
Measure: Incidence and severity of adverse events Time: Primary endpoint at day 5Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans. In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days. The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.
Description: Proportion of patients with clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a 7-point ordinal scale, or both.
Measure: Time to clinical improvement Time: 28 daysDescription: Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Days 7, 10, 14 and 28
Measure: Time to SARS-CoV-2 negativity Time: 28 daysDescription: Temporal patterns of SARS-CoV-2 viral load quantified by RT-PCR from nasal swabs or sputum of patients receiving SOC alone versus SOC plus study drug
Measure: Difference in SARS-CoV-2 AUC Time: 28 daysDescription: Time to symptoms resolution as monitored by the Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire with some modifications for COVID-19
Measure: Time to symptoms resolution Time: 28 daysThe effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.
This study is a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of mild, moderate and severe COVID-19 patients. 100 mg of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial.
Description: 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 extracorporeal membrane oxygenation (ECMO). Death.
Measure: Change in Clinical status of subject on a 7-point ordinal scale Time: Week 2Description: PCR for SARS-CoV-2 in pharyngeal swab
Measure: PCR test Time: Week 2 and Week 4Description: Occurrence of supplemental Oxygen
Measure: Supplemental Oxygen Time: Week 2 and Week 4Description: Occurrence of Mechanical Ventilation
Measure: Mechanical Ventilation Time: Week 2 and Week 4Description: Occurence of Adverse events
Measure: Incidence of Treatment-Emergent Adverse Events Time: Week 2 and Week 4Description: Laboratory Assessments
Measure: Laboratory Assessments Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: C-reactive protein (CRP) Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: Interleukin 6 (IL-6) Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: D-dimer Time: Week 2 and Week 4Finding effective strategies to treat or prevent the novel coronavirus disease that started in 2019 (COVID-19) is a global public health priority. Potential therapeutics and vaccines are now being investigated in over 1500 clinical trials. Clinical features of the disease include overproduction of reactive oxygen species which induces oxidative stress responses and contribute to acute lung injury. This presents a potential treatment strategy involving antioxidation therapy. In this pilot study, 90 COVID-19 patients aged 18-75 years will be recruited into two groups. The 45 patients in group 1 will receive the standard of care determined by their primary care providers while the 45 patients in group 2 will receive both the standard of care combined with daily antioxidant supplement for 14 days. All patients will be monitored for a total of 28 days with daily monitoring of symptoms and nasopharyngeal swab for SARS-CoV-2 test on days 3, 7, 14 and 28. The study will compare the following between the two groups: (1) the proportion of patients with clinical improvement (defined as live discharge from hospital, decrease of at least 2 points from baseline on a 7-point ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by PCR on days 3, 7, and 14.
Description: Time to clinical improvement (defined as time from randomization to either an improvement of two points on a 7-category ordinal scale or discharge from the hospital, whichever came first, or both)
Measure: Time to clinical improvement Time: 28 daysDescription: Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Day 14
Measure: Time to SARS-CoV-2 negativity Time: 14 daysDescription: Clinical status as assessed with the seven-category ordinal scale on day 14
Measure: Clinical status on day 14 Time: 14 daysDescription: Respiratory failure or Acute Respiratory Distress Syndrome, Acute Kidney Injury, secondary infection, shock, severe anemia, acute gastritis, unconsciousness, acute heart failure
Measure: Serious adverse events Time: 28 daysDescription: Nausea, vomiting, and diarrhea
Measure: Gastrointesntinal adverse events Time: 28 daysTo determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Description: To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Measure: Change in the proportion of patients alive and free from respiratory failure Time: 28 DaysDescription: To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.
Measure: Change in the proportion of patients alive and free of ventilator use or ECMO Time: 28 DaysDescription: To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo.
Measure: Mortality Rate Time: 28 and 56 DaysDescription: Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.
Measure: Clinical Change Time: 14 and 28 DaysDescription: Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.
Measure: Adverse Events Time: up to 56 daysCOVID-19's high mortality may be driven by hyperinflammation. Interleukin-6 (IL-6) axis therapies may reduce COVID-19 mortality. Retrospective analyses of tocilizumab in severe to critical COVID-19 patients have demonstrated survival advantage and lower likelihood of requiring invasive ventilation following tocilizumab administration. The majority of patients have rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose. The investigators hypothesized that a dose of tocilizumab significantly lower than the EMA- and FDA-labeled dose (8mg/kg) as well as the emerging standard of care dose (400mg) may be effective in patients with COVID-19 pneumonitis and hyperinflammation. Advantages to the lower dose of tocilizumab may include lower likelihood of secondary bacterial infections as well as extension of this drug's limited supply. The investigators conducted an adaptive single-arm phase 2 trial (NCT04331795) evaluating clinical and biochemical response to low-dose tocilizumab in patients with COVID-19 pneumonitis and hyperinflammation. This multi-center, prospective, randomized controlled phase 2 trial -- designed as two sub-studies to allow for the possible emergence of data demonstrating the clinical efficacy of tocilizumab 8mg/kg or 400mg -- formally tests the clinical efficacy of low-dose tocilizumab in COVID-19 pneumonia. Sub-Study A Primary Objective A: To establish whether low-dose tocilizumab reduces the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation, when compared to a tocilizumab-free standard of care. Hypothesis A: The investigators hypothesize that low-dose tocilizumab, when compared to a tocilizumab-free standard of care, decreases the time to recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation by three days or more. Sub-Study B Primary Objective B: To establish whether low-dose tocilizumab is near-equivalent to high-dose tocilizumab (400mg or 8 mg/kg) in reducing the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation. Hypothesis B: The investigators hypothesize that low-dose tocilizumab is near-equivalent to high-dose tocilizumab in reducing the time to clinical recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation.
Description: Day of recovery is defined as the first day on which the patient achieves one of the following two categories from the seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Measure: Time to Recovery Time: 28 daysDescription: This will be defined as the percentage of patients in a given arm of the study achieving one of the above two categories on the ordinal scale on day 7. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Measure: Achievement of Recovery Time: 7 daysDescription: This will be defined as the percentage of patients in a given arm of the study who are alive thirty days following randomization. Patients who are discharged to hospice will be counted as deceased on the day of discharge. Patients who are transitioned to inpatient hospice or inpatient comfort measures only will be counted as deceased on the day of transition.
Measure: Overall Survival Time: 28 daysDescription: This will be defined as the number of days that pass between the day of a patient's randomization and his or her discharge from the hospital.
Measure: Hospital Length of Stay Time: Up to 1 yearDescription: Maximum temperature within 24-hour periods of time immediately prior to, immediately following, and then every 24 hours thereafter randomization. The primary endpoint is a measured Tmax in the 24-hour period immediately following randomization that is lower than the measured Tmax in the 24-hour period immediately preceding randomization.
Measure: Clinical Response: Maximum Temperature (Tmax) Response Time: 24 hoursDescription: This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of invasive mechanical ventilation during the course of the patient's COVID-19 infection.
Measure: Clinical Response: Rate of Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between initiation and cessation of non-elective invasive mechanical ventilation.
Measure: Clinical Response: Duration of Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between randomization and the initiation of non-elective invasive mechanical ventilation. This will be treated as a time-to-event with possible censoring.
Measure: Clinical Response: Time to Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a binary outcome defined as utilization of any vasopressor or inotropic medication.
Measure: Clinical Response: Rate of Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor medications.
Measure: Clinical Response: Duration of Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between randomization and the initiation of any vasopressor or inotropic medication. This will be treated as a time-to-event with possible censoring.
Measure: Clinical Response: Time to Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be an ordinal outcome defined by the number of days counted from randomization over which the participant requires supplemental oxygen in excess over his/her baseline supplemental oxygen requirement. The supplemental oxygen requirement is defined as the highest liters-per-minute flow of supplemental oxygen required by the patient each day over the course of the hospitalization.
Measure: Clinical Response: Duration of Increased Supplemental Oxygen from Baseline Time: 28 daysDescription: This will be a binary outcome defined as the presence or absence of a decline in CRP of ≥ 25% from baseline CRP in the 27 +/- 3 hours after tocilizumab administration, as compared to pre-treatment baseline.
Measure: Biochemical Response: C-reactive Protein Response Rate Time: 24 hoursDescription: This will be defined as the percentage of patients in a study arm who develop serious non-COVID-19 viral, bacterial, or fungal infections (e.g., bloodstream infection, hospital-acquired pneumonia, ventilator-associated pneumonia, opportunistic infection) following randomization and up to the 28-day assessment of overall survival.
Measure: Safety: Rate of Secondary Infection Time: 28 daysCOVID-19's high mortality may be driven by hyperinflammation. Interleukin-6 (IL-6) axis therapies may reduce COVID-19 mortality. Retrospective analyses of tocilizumab in severe to critical COVID-19 patients have demonstrated survival advantage and lower likelihood of requiring invasive ventilation following tocilizumab administration. The majority of patients have rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose. The investigators hypothesized that a dose of tocilizumab significantly lower than the EMA- and FDA-labeled dose (8mg/kg) as well as the emerging standard of care dose (400mg) may be effective in patients with COVID-19 pneumonitis and hyperinflammation. Advantages to the lower dose of tocilizumab may include lower likelihood of secondary bacterial infections as well as extension of this drug's limited supply. The investigators conducted an adaptive single-arm phase 2 trial (NCT04331795) evaluating clinical and biochemical response to low-dose tocilizumab in patients with COVID-19 pneumonitis and hyperinflammation. This multi-center, prospective, randomized controlled phase 2 trial -- designed as two sub-studies to allow for the possible emergence of data demonstrating the clinical efficacy of tocilizumab 8mg/kg or 400mg -- formally tests the clinical efficacy of low-dose tocilizumab in COVID-19 pneumonia. Sub-Study A Primary Objective A: To establish whether low-dose tocilizumab reduces the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation, when compared to a tocilizumab-free standard of care. Hypothesis A: The investigators hypothesize that low-dose tocilizumab, when compared to a tocilizumab-free standard of care, decreases the time to recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation by three days or more. Sub-Study B Primary Objective B: To establish whether low-dose tocilizumab is near-equivalent to high-dose tocilizumab (400mg or 8 mg/kg) in reducing the time to clinical recovery in patients with COVID-19 pneumonitis and hyperinflammation. Hypothesis B: The investigators hypothesize that low-dose tocilizumab is near-equivalent to high-dose tocilizumab in reducing the time to clinical recovery in hospitalized, non-invasively ventilated patients with COVID-19 pneumonitis and hyperinflammation.
Description: Day of recovery is defined as the first day on which the patient achieves one of the following two categories from the seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Measure: Time to Recovery Time: 28 daysDescription: This will be defined as the percentage of patients in a given arm of the study achieving one of the above two categories on the ordinal scale on day 7. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Measure: Achievement of Recovery Time: 7 daysDescription: This will be defined as the percentage of patients in a given arm of the study who are alive thirty days following randomization. Patients who are discharged to hospice will be counted as deceased on the day of discharge. Patients who are transitioned to inpatient hospice or inpatient comfort measures only will be counted as deceased on the day of transition.
Measure: Overall Survival Time: 28 daysDescription: This will be defined as the number of days that pass between the day of a patient's randomization and his or her discharge from the hospital.
Measure: Hospital Length of Stay Time: Up to 1 yearDescription: Maximum temperature within 24-hour periods of time immediately prior to, immediately following, and then every 24 hours thereafter randomization. The primary endpoint is a measured Tmax in the 24-hour period immediately following randomization that is lower than the measured Tmax in the 24-hour period immediately preceding randomization.
Measure: Clinical Response: Maximum Temperature (Tmax) Response Time: 24 hoursDescription: This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of invasive mechanical ventilation during the course of the patient's COVID-19 infection.
Measure: Clinical Response: Rate of Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between initiation and cessation of non-elective invasive mechanical ventilation.
Measure: Clinical Response: Duration of Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between randomization and the initiation of non-elective invasive mechanical ventilation. This will be treated as a time-to-event with possible censoring.
Measure: Clinical Response: Time to Non-Elective Invasive Mechanical Ventilation Time: Up to 28 daysDescription: This will be a binary outcome defined as utilization of any vasopressor or inotropic medication.
Measure: Clinical Response: Rate of Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor medications.
Measure: Clinical Response: Duration of Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be a continuous outcome defined by the amount of time between randomization and the initiation of any vasopressor or inotropic medication. This will be treated as a time-to-event with possible censoring.
Measure: Clinical Response: Time to Vasopressor/Inotrope Utilization Time: Up to 28 daysDescription: This will be an ordinal outcome defined by the number of days counted from randomization over which the participant requires supplemental oxygen in excess over his/her baseline supplemental oxygen requirement. The supplemental oxygen requirement is defined as the highest liters-per-minute flow of supplemental oxygen required by the patient each day over the course of the hospitalization.
Measure: Clinical Response: Duration of Increased Supplemental Oxygen from Baseline Time: 28 daysDescription: This will be a binary outcome defined as the presence or absence of a decline in CRP of ≥ 25% from baseline CRP in the 27 +/- 3 hours after tocilizumab administration, as compared to pre-treatment baseline.
Measure: Biochemical Response: C-reactive Protein Response Rate Time: 24 hoursDescription: This will be defined as the percentage of patients in a study arm who develop serious non-COVID-19 viral, bacterial, or fungal infections (e.g., bloodstream infection, hospital-acquired pneumonia, ventilator-associated pneumonia, opportunistic infection) following randomization and up to the 28-day assessment of overall survival.
Measure: Safety: Rate of Secondary Infection Time: 28 daysThis is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
Description: 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 extracorporeal membrane oxygenation (ECMO). Death.
Measure: Change in Clinical status of subject on a 7-point ordinal scale Time: Week 2Description: PCR for SARS-CoV-2 in pharyngeal swab
Measure: PCR test Time: Week 2 and Week 4Description: Occurrence of supplemental Oxygen
Measure: Supplemental Oxygen Time: Week 2 and Week 4Description: Occurrence of Mechanical Ventilation
Measure: Mechanical Ventilation Time: Week 2 and Week 4Description: Occurence of Adverse events
Measure: Incidence of Treatment-Emergent Adverse Events Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: C-reactive protein (CRP) Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: Interleukin 6 (IL-6) Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: D-dimer Time: Week 2 and Week 4Description: type II class of interferons
Measure: Interferon gamma Time: Week 2 and Week 4Description: proteins
Measure: Ferritin Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: TNF alpha Time: Week 2 and Week 4Description: Inflammatory Biomarker
Measure: Interleukin 1-β Time: Week 2 and Week 4The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
Description: Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Measure: PaO2/FiO2 ratio Time: 0, 24, 48, and 72 hours after initiation of core warmingDescription: Determine the change in viral load (measured in tracheal aspirate or other appropriate sample as available) after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Measure: Viral Load Measurement Time: 72 hours after initiation of core warmingDescription: Measure the impact of core warming on duration of mechanical ventilation.
Measure: Duration of mechanical ventilation Time: 72 hours after initiation of core warmingDescription: Determine impact of core warming on patient mortality.
Measure: Mortality Time: 30 daysA randomised controlled trial of open label Prolectin-M; a (1-6)-alpha-D-Mannopyranose among patients with RT PCR positive COVID-19 patients.
Description: Change in absolute viral copy number
Measure: SarsCoV2 viral copy number Time: 7 days from randomisationDescription: 7-point severity score (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 extracorporeal membrane oxygenation (ECMO); Death
Measure: b. Disease progression will be measured on a 7-point scale at 28 days. A 2-point change will be considered disease progression. Time: 28 days from randomisationThe primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.
Description: Richmond Agitation Sedation Scale (RASS) score ranges from +4 (combative) to 0 (alert & calm) to -5 (unarousable).
Measure: Change from baseline RASS score of +3 or greater Time: Baseline, Day 7Description: Total dose of dexmedetomidine administered will be reported from baseline RASS score of +3 or greater.
Measure: Total dose of dexmedetomidine administered Time: Day 7Description: Incidence of Treatment Emergent Adverse Events will include: QTc duration > 470 msecs. Increase in Liver Function Tests to a Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Suicidality reported as having a score of moderate or high risk using the Columbia-Suicide Severity Rating Scale Screening (C-SSRS). C-SSRS is a calculated risk assessment tool that scores suicidality from no risk to high risk.
Measure: Incidence of Treatment Emergent Adverse Events Time: Day 7Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.
Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.
Measure: pH Time: 10 daysDescription: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.
Measure: Number of Days Alive Free of Stage 2-3 AKI Time: 28 days post-treatmentDescription: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).
Measure: Stage 2-3 AKI Time: 28 daysDescription: Ventilator-free days to 28 days
Measure: Vent-Free Time: 28 daysDescription: Hospital-free days to 60 days
Measure: Hospital-Free Time: 60 days post-index hospitalizationThe purpose of this study is to determine if a video visit with an advanced practice provider (Nurse Practitioner or Physician Assistant) within 7 days of discharge from Hospital Internal Medicine services will increase patient compliance with medication, self-management and home supports after hospital discharge.
Description: Number of participants to adhere to post-discharge recommendation including medication compliance, self-management, and home supports post hospital discharge
Measure: Adherence to post-discharge recommendations Time: Through study completion, approximately 30 daysDescription: Number of participants with hospital emergency department visits and hospital readmission within 7 days of discharge
Measure: 7 day readmission rate Time: 7 days after hospital dischargeDescription: Number of participants with hospital emergency department visits and hospital readmission within 30 days of discharge
Measure: 30 day readmission rate Time: 30 days after hospital dischargeSeptic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.
Description: Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.
Measure: Change in Plasma Renin Levels Time: Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)Description: Cystatin C, NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.
Measure: Change in Renal Biomarkers Time: Until shock resolution, up to 14 days (at baseline, 24 hours, and shock resolution, up to 14 days)Description: Time from enrollment to discontinuation of catecholamines
Measure: Time to discontinuation of catecholamines Time: Until shock resolution, up to 14 daysDescription: Number of days in the intensive care unit (ICU).
Measure: ICU Length of Stay Time: From enrollment to ICU discharge, up to 28 days following enrollmentDescription: Assessment of all-cause mortality within hospital admission
Measure: In-hospital mortality Time: Up to 3 months following enrollmentDescription: Days free of renal replacement therapy from enrollment up to day 28
Measure: Renal replacement therapy-free days Time: Within 28 days of enrollmentDescription: Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection
Measure: Safety outcomes Time: Up to 72 hours following shock resolution, no longer than 17 days from enrollmentThe principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Description: dead or alive
Measure: Vital status Time: at day 28Description: dead or alive
Measure: day 90 mortality Time: at day 90Description: to assess the ventilator free days
Measure: number of ventilator-free days at day 28 Time: at day 28Description: to assess the number of renal replacement therapy free days
Measure: number of renal replacement therapy free days at day 28 Time: at day 28Description: to assess the number of vasopressors free-days
Measure: number of vasopressors free-days at day 28 Time: at day 28Description: to assess if ECMO was required
Measure: use of ECMO before day 28 Time: till day 28Description: to assess the value of SOFA score
Measure: value of the SOFA score at days 7, 14 and 28 Time: Day 1, 7, 14, 28Description: to assess the changes in SOFA scores (delta SOFA)
Measure: changes in SOFA scores (delta SOFA) over 7, 14 and 28 days Time: Day 7, 14 and 28 daysDescription: assessment of the SARS-CoV-2 viral load, expressed as cycle threshold, [2] in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28
Measure: assessment of the SARS-CoV-2 viral load Time: Days 7, 14 and 28Description: to assess the concentrations of C reactive protein (CRP)
Measure: blood C reactive protein (CRP) concentration Time: Days 7, 14 and 28Description: to assess the concentration of ferritin
Measure: ferritin concentration Time: Days 7, 14 and 28Description: to assess the count of lymphocyte
Measure: lymphocyte count Time: Days 7, 14 and 28Description: to assess the lenght of stay in the acute care
Measure: length of stay in the acute care hospital Time: through study completion, 1 yearDescription: to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home
Measure: location of the patient Time: Day 90Description: to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)
Measure: Katz Index of independence in Activity Day Living functional score Time: Day 90 and 365Description: to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90 and 365Description: The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.
Measure: Quality of life scale EQ-5D-5L Time: Day 90 and 365Description: to assess the transfusion related adverse events
Measure: Transfusion related adverse events Time: till 28 daysTo study signals of efficacy and safety of a currently available dosage form (IM) of EG-HPCP-03a in reducing the severity of respiratory disease in patients hospitalized with SARS-CoV-2 virus.
Description: Patients will be assessed for COVID-19 Ordinal Scale for Clinical Improvement scores and respiratory status throughout the study
Measure: The proportion of patients alive and without respiratory failure Time: First dose date to 28 days treatment dosing periodAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports