Name (Synonyms) | Correlation | |
---|---|---|
drug2335 | Standard screening strategy Wiki | 0.20 |
drug737 | Delayed diagnostics Anyplex TMII RV16 Detection Wiki | 0.20 |
drug1811 | Physical Exercises Wiki | 0.20 |
drug369 | Blood and derivatives. Wiki | 0.20 |
drug2001 | RESP301, a Nitric Oxide generating solution Wiki | 0.20 |
drug2427 | TERA Intervention Wiki | 0.20 |
drug2120 | Ruxolitinib plus simvastatin Wiki | 0.20 |
drug1141 | Hypothermia Wiki | 0.20 |
drug552 | Chat-based support Wiki | 0.20 |
drug256 | Awake Proning Wiki | 0.20 |
drug1211 | Inhaled nitric oxide gas Wiki | 0.20 |
drug1899 | Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 Wiki | 0.20 |
drug650 | Convalescent Plasma 1 Unit Wiki | 0.20 |
drug98 | AWARD advice Wiki | 0.20 |
drug2718 | Zinc Gluconate Wiki | 0.20 |
drug1479 | Messaging Wiki | 0.20 |
drug2476 | Tested for SARS-CoV-2 (regardless of the result) Wiki | 0.20 |
drug583 | Clinical diagnosis of COVID-19 by a health care professional Wiki | 0.20 |
drug1030 | HLCM051 Wiki | 0.20 |
drug398 | Brequinar Wiki | 0.20 |
drug2161 | SMS-based support Wiki | 0.20 |
drug216 | Ascorbic Acid and Zinc Gluconate Wiki | 0.20 |
drug929 | Favipiravir + Standard of Care Wiki | 0.20 |
drug1881 | Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 Wiki | 0.20 |
drug1330 | Lenzilumab Wiki | 0.20 |
drug444 | COSH Self-help smoking cessation booklet Wiki | 0.20 |
drug1039 | Health warning leaflet Wiki | 0.20 |
drug1721 | Oxytocin Wiki | 0.20 |
drug1589 | New screening strategy Wiki | 0.20 |
drug198 | Antioxidation Therapy Wiki | 0.20 |
drug157 | Ampion Wiki | 0.20 |
drug1880 | Positive feedback Wiki | 0.20 |
drug2272 | Six-month ARV dispensing Wiki | 0.20 |
drug105 | Abivertinib Wiki | 0.20 |
drug1341 | LifeSignals Biosensor 1AX* Wiki | 0.20 |
drug2173 | STI-1499 Wiki | 0.20 |
drug744 | Desidustat Wiki | 0.20 |
drug2052 | Referral card Wiki | 0.20 |
drug1655 | Nutrition support Wiki | 0.20 |
drug2782 | community health worker support Wiki | 0.20 |
drug1602 | Nitazoxanide and atazanavir/ritonavir Wiki | 0.20 |
drug2774 | care as usual Wiki | 0.20 |
drug651 | Convalescent Plasma 2 Units Wiki | 0.20 |
drug1584 | Neuromuscular Blocking Agents Wiki | 0.20 |
drug1179 | Imatinib Mesylate Wiki | 0.20 |
drug490 | COVSurf Drug Delivery System Wiki | 0.20 |
drug481 | COVID-19 related health warning leaflet Wiki | 0.20 |
drug2028 | Rapid diagnostics using Anyplex TMII RV16 Detection Wiki | 0.20 |
drug99 | AWARD plus COVID-specific advice Wiki | 0.20 |
drug2808 | ensoETM device Wiki | 0.20 |
drug2422 | TD-0903 Wiki | 0.14 |
drug1998 | REGN10933+REGN10987 combination therapy Wiki | 0.14 |
drug2880 | mRNA-1273 Wiki | 0.14 |
drug1696 | Opaganib Wiki | 0.11 |
drug2069 | Remestemcel-L Wiki | 0.11 |
drug2067 | Remdesivir Wiki | 0.10 |
drug215 | Ascorbic Acid Wiki | 0.10 |
drug512 | Camostat Mesilate Wiki | 0.09 |
drug3018 | survey Wiki | 0.08 |
drug2662 | Vitamin C Wiki | 0.06 |
drug923 | Favipiravir Wiki | 0.05 |
drug1822 | Placebo Wiki | 0.04 |
drug647 | Convalescent Plasma Wiki | 0.04 |
drug1086 | Hydroxychloroquine Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D005335 | Fever of Unknown Origin NIH | 0.20 |
D000856 | Anorexia Nervosa NIH | 0.20 |
D000855 | Anorexia NIH | 0.20 |
D002637 | Chest Pain NIH | 0.20 |
D007035 | Hypothermia NIH | 0.20 |
D018352 | Coronavirus Infections NIH | 0.13 |
D003428 | Cross Infection NIH | 0.11 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.11 |
D012327 | RNA Virus Infections NIH | 0.10 |
D015658 | HIV Infections NIH | 0.08 |
D055371 | Acute Lung Injury NIH | 0.08 |
D004417 | Dyspnea NIH | 0.07 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
D000077062 | Burnout, Psychological NIH | 0.06 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
D003141 | Communicable Diseases NIH | 0.05 |
D014777 | Virus Diseases NIH | 0.05 |
D007239 | Infection NIH | 0.04 |
D013577 | Syndrome NIH | 0.04 |
D013315 | Stress, Psychological NIH | 0.04 |
D055370 | Lung Injury NIH | 0.04 |
D012141 | Respiratory Tract Infections NIH | 0.04 |
D011014 | Pneumonia NIH | 0.03 |
D016638 | Critical Illness NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002039 | Anorexia HPO | 0.20 |
HP:0002045 | Hypothermia HPO | 0.20 |
HP:0100749 | Chest pain HPO | 0.20 |
HP:0002098 | Respiratory distress HPO | 0.07 |
HP:0011947 | Respiratory tract infection HPO | 0.04 |
HP:0002090 | Pneumonia HPO | 0.03 |
There are 26 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, preliminary efficacy of four dose levels of a single dose of STI-1499 (COVI-GUARD), a COVID-19 targeting monoclonal antibody, in hospitalized patients with COVID-19
Description: Types, frequencies, and severities of adverse events and their relationships to STI-1499
Measure: Incidence of treatment-emergent adverse events (safety and tolerability of STI-1499) Time: Randomization through study completion at 28 daysDescription: All-cause mortality at Day 28
Measure: All-cause mortality Time: Randomization through Day 28Description: Change from baseline in clinical status on a 7-point ordinal scale where higher score means better outcome (1=Death, 7=Not hospitalized and no limitations on activities)
Measure: Change in clinical status Time: Randomization to Day 7, 14, 28Description: Change from baseline in SOFA score where lower score means better outcome
Measure: Change in Sequential Organ Failure Assessment (SOFA) score Time: Randomization to Day 7, 14, 28Description: Change from baseline in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen
Measure: Change in PaO2:FiO2 Time: Randomization to Day 7, 14, 28Description: Length of hospitalization of participants (followed up to Day 28)
Measure: Length of hospitalization Time: Randomization up to Day 28Description: Percentage of participants requiring mechanical ventilation at Day 7, 14, and 28
Measure: Percentage of participants requiring mechanical ventilation Time: Randomization to Day 7, 14, 28Description: Change from baseline in viral shedding as assessed by RT-PCR
Measure: Change in viral shedding Time: Randomization to Day 7, 14, 21, 28Description: Incidence of anti-drug antibody (ADA)
Measure: Immunogenicity of STI-1499 Time: Randomization to Day 21, 28This 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 group. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients 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 days