Covid 19 Research using Clinical Trials (Home Page)
Camostat MesilateWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug947 | Fixed Anchoring Strategy Wiki | 0.45 |
| drug400 | Brief Behavioral Activation Treatment Wiki | 0.45 |
| drug1628 | Non-Anchoring Strategy Control Wiki | 0.45 |
| drug212 | Artemesia annua Wiki | 0.45 |
| drug385 | Blood samples collection Wiki | 0.45 |
| drug1801 | Personalized Anchoring Strategy Wiki | 0.45 |
| drug1260 | Isavuconazonium sulfate Wiki | 0.32 |
| drug1117 | Hydroxychloroquine and Azithromycin Wiki | 0.32 |
| drug2187 | Saliva collection Wiki | 0.20 |
| drug3018 | survey Wiki | 0.18 |
| drug1270 | Ivermectin Wiki | 0.11 |
| drug2319 | Standard of Care Wiki | 0.09 |
| drug1853 | Placebo oral tablet Wiki | 0.08 |
| drug1822 | Placebo Wiki | 0.05 |
| drug1086 | Hydroxychloroquine Wiki | 0.04 |
Correlated MeSH Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009091 | Mucormycosis NIH | 0.45 |
| D001238 | Asphyxia Neonatorum NIH | 0.45 |
| D001228 | Aspergillosis NIH | 0.45 |
| D020096 | Zygomycosis NIH | 0.45 |
| D003866 | Depressive Disorder NIH | 0.11 |
| D003863 | Depression, NIH | 0.07 |
| D018352 | Coronavirus Infections NIH | 0.05 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D055371 | Acute Lung Injury NIH | 0.04 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D007239 | Infection NIH | 0.03 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012768 | Neonatal asphyxia HPO | 0.45 |
| HP:0000716 | Depressivity HPO | 0.11 |
There are 5 clinical trials
Clinical Trials
1 The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.
NCT04321096 Corona Virus Infection Drug: Camostat Mesilate Drug: Placebo oral tablet MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale
Measure: Cohort 1: Days to clinical improvement from study enrolment Time: 30 daysDescription: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)
Measure: Cohort 2: Days to clinical improvement from study enrolment Time: 30 daysSecondary Outcomes
Measure: Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) Time: 30 daysDescription: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. 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 supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 Time: 30 daysDescription: Mortality
Measure: Cohort 1: Day 30 mortality Time: 30 daysDescription: NEWS2
Measure: Cohort 1: Change in NEW(2) score from baseline to day 30 Time: 30 daysDescription: ICU
Measure: Cohort 1: Admission to ICU Time: 30 daysDescription: invasive mechanical ventilation or ECMO
Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO Time: 30 daysDescription: Nasal or high-flow oxygen
Measure: Cohort 1: Duration of supplemental oxygen (days) Time: 30 daysDescription: Subjective clinical improvement
Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 Time: 30 daysDescription: No of new COVID-19 infections in the household
Measure: Cohort 2: Number participant-reported secondary infection of housemates Time: 30 daysDescription: Hospital admission
Measure: Cohort 2: Time to hospital admission related to COVID-19 infection Time: 30 days2 Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection
Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.
NCT04338906 COVID Drug: Camostat Mesilate Drug: Placebo Drug: Hydroxychloroquine
Primary Outcomes
Measure: Not hospitalized Time: day 14 from baselineSecondary Outcomes
Measure: Time to improvement of 2 categories from admission on a 7-point ordinal scale Time: day 14Measure: Proportion of participants in each group with normalization of fever Time: day 7 and day 14
Measure: Proportion of participants in each group with oxygen saturation > 94% on room air for >24h Time: day 7 and day 14
Measure: Time to fever normalization (if febrile at baseline) Time: within 14 days
Measure: Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline) Time: within 14 days
Measure: Time to first negative SARS-CoV-2 PCR in lower respiratory tract specimens (sputum, bronchoalveolar lavage, tracheal aspirate) (if positive at baseline) Time: within 14 days
Measure: Duration of oxygen therapy Time: within 28 days
Measure: Proportion of participants in each group with need for mechanical ventilation Time: within 28 days
Measure: Duration of hospitalization Time: within 28 days
Measure: All cause mortality Time: day 28
3 The Effect of Camostat Mesylate on COVID-19 Infection in Ambulatory Patients: An Investigator-Initiated Randomized, Placebo-Controlled, Phase IIa Trial
The rationale of the present clinical trial is that an orally available drug given to outpatients that could reduce the viral burden in the upper respiratory tract could forestall complications of SARS-CoV-2 infection and reduce transmission from one infected individual to another.
NCT04353284 COVID-19 Drug: Camostat Mesilate Other: Placebo
Primary Outcomes
Description: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.
Measure: Change in SARS-COV-2 viral load Time: 5 daysSecondary Outcomes
Description: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.
Measure: Change in SARS-COV-2 viral load Time: 3 daysDescription: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.
Measure: Change in SARS-COV-2 viral load Time: 7 daysDescription: Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.
Measure: Change in positive COVID-19 status Time: 7 daysDescription: Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in COVID-19 symptom severity Time: 7 daysDescription: Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in COVID-19 symptom severity Time: 14 daysDescription: Change of COVID-19 symptom score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in COVID-19 symptom frequency Time: 7 daysDescription: Change of COVID-19 symptom score from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in COVID-19 symptom frequency Time: 14 daysDescription: Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in body temperature Time: 7 daysDescription: Change of COVID-19 symptom score from baseline to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.
Measure: Change in body temperature Time: 14 days4 Randomized, Multi-arm Phase II Trial of Novel Agents for Treatment of High-risk COVID-19 Positive Patients
This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.
NCT04374019 COVID Sars-CoV2 Drug: Hydroxychloroquine and Azithromycin Drug: Ivermectin Drug: Camostat Mesilate Dietary Supplement: Artemesia annua
Primary Outcomes
Description: Proportion of patients experiencing clinical deterioration. Clinical deterioration is defined as a less than a 2-point change from the initial COVID 7-Point Ordinal Outcomes Scale within 14 days from the study start. This scale ranges from 1-7. Lower scores indicate worse outcomes (death); higher scores indicate fewer symptoms and better outcomes.
Measure: Clinical Deterioration Time: 14 daysSecondary Outcomes
Description: The change in (clearance of) viral RNA will be measured by PCR testing at days 1, 14, 28, and 40 days.
Measure: Change in Viral Load Time: 40 daysDescription: Percentage of patients that experience severe respiratory or other organ failure.
Measure: Rate of Organ Failure Time: 28 daysDescription: Percentage of patients requiring ICU admission or ventilation.
Measure: Progression to ICU Care or Ventilation Time: 28 daysDescription: Clinical status will be assessed using the COVID 7-Point Ordinal Outcomes Scale. This scale ranges from 1-7. Lower scores indicate worse outcomes; higher scores indicate fewer symptoms and better outcomes.
Measure: Change in Clinical Status Time: 14 daysDescription: Percentage of patients who have died by day 14.
Measure: Mortality Time: 14 daysDescription: Percentage of patients experiencing severe adverse events, defined as grade 3 non-hematologic or greater by DMID Toxicity Scale for Determining Severity of Adverse Events.
Measure: Rate of severe adverse events Time: 14 daysDescription: Number of days patients do not require oxygen supplementation.
Measure: Oxygen-free days Time: 28 daysDescription: Number of days patients do not require mechanical ventilation.
Measure: Ventilator-free days Time: 28 daysDescription: Number of days patients do not require vasopressor treatment.
Measure: Vasopressor-free days Time: 28 daysDescription: Number of days patients do not require ICU services.
Measure: ICU-free days Time: 28 daysDescription: Number of days patients do not require hospitalization.
Measure: Hospital-free days Time: 28 daysDescription: Proportion of patients meeting Hy's law criteria.
Measure: Patients meeting Hy's Law criteria Time: 28 daysDescription: Proportion of patients with changes in the following liver function tests: Any ALT or AST ≥ 5 x ULN; any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the ULN); Persistent ALT ≥ 3 x ULN for a period of more than 4 weeks
Measure: Liver Function Time: 28 daysDescription: Proportion of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes, or abnormalities including severe QTc prolongation of > 500 ms.
Measure: Heart Function Time: 28 days5 RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
To 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.
NCT04470544 Severe Acute Respiratory Syndrome Drug: Camostat Mesilate Other: Standard of Care MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections
Primary Outcomes
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 DaysSecondary Outcomes
Description: 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