|drug1134||Electrical Impedance tomography Wiki||0.58|
|drug1714||Ivermectin 6 MG Oral Tablet (2 tablets) Wiki||0.58|
|D011665||Pulmonary Valve Insufficiency NIH||0.22|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.10|
|D055371||Acute Lung Injury NIH||0.10|
There are 3 clinical trials
In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
Description: Proportion of participants with an occurrence of deathMeasure: Efficacy phase: Death Time: From inclusion (day0) to day 14
Description: Proportion of participants who had an indication for oxygen therapyMeasure: Efficacy phase: oxygen therapy Time: From inclusion (day0) to day 14
Description: Proportion of participants who had an indication for hospitalizationMeasure: Efficacy phase: hospitalization Time: From inclusion (day0) to day 14
Description: Proportion of deaths, overall and by cause, in each groupMeasure: Death and causes of death Time: From inclusion (day0) to day 28
Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INRMeasure: Haematological markers evolution Time: from inclusion (day 0) to day 7
Description: Evolution of Inflammatory markers in each group : PCT, CRPMeasure: Inflammatory markers evolution Time: from inclusion (day 0) to day 7
Description: Number and proportion of grade 1,2,3,4 adverse events in each groupMeasure: Adverse events Time: from inclusion (day 0) to day 28
Description: Number and proportion of grade 1,2,3,4 adverse events in each groupMeasure: Adverse reactions Time: from inclusion (day 0) to day 28
Description: Acceptability of the treatment by participant will be assessed with an interviewMeasure: Acceptability of the treatment Time: from inclusion (day 0) to day 10
Description: Proportion of participants who received at least one day of antibiotic therapyMeasure: Antibiotic consumption Time: from inclusion (day 0) to day 28
Description: Proportion of participants who experienced a worsening of oxygen saturationMeasure: Oxygen saturation worsening Time: from inclusion (day 0) to day 28
Description: Proportion of participants who completed the prescribed protocol treatmentMeasure: protocol follow-up Time: from inclusion (day 0) to day 10
In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.
Rationale: The renin-angiotensin-aldosterone system (RAAS) dysregulation may play a central role in the pathophysiology of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection associated acute lung injury (ALI) / acute respiratory distress syndrome (ARDS). In the RAAS, Angiotensin I (Ang I) is converted to angiotensin II (Ang II) by angiotensin converting enzyme (ACE). Ang II mediates vasoconstrictive, pro-inflammatory and pro-oxidative effects through agonism at Ang II type 1 receptor (AT1R). ACE2 converts Ang II to angiotensin 1-7 (Ang1-7), which finally binds to Mas receptor (MasR) and mediates many beneficial actions, including vasodilation and anti-inflammatory, anti-oxidant and antiapoptotic effects. ACE2, a homologue of ACE, is an integral cell membrane protein with a catalytic domain on the extracellular surface exposed to vasoactive peptides. SARS-CoV-2 penetrates the cell through ACE2, and the increase of this receptor (due to the use of ACE inhibitors or angiotensin receptor blockers [ARBs]) may facilitate SARS-CoV-2 infection, which might increase the risk of developing severe and fatal SARS-CoV-2 infection. However, through upregulation of ACE2, ACE inhibitors/ARBs can exert anti-inflammatory and antioxidative effects, which may be beneficial in preventing ALI and ARDS. Objective: To evaluate the effectiveness and safety of telmisartan in respiratory failure due to COVID-19. Study design: This is an open label, phase 2 clinical trial. Study population: Adult hospitalized SARS-CoV-2-infected patients (n=60). Intervention: The active-treatment arm will receive telmisartan 40 mg daily and the control arm will receive standard care. Treatment duration will be 14 days or up to hospital discharge <14 days or occurrence of the primary endpoint if <14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) Mechanical ventilation or 2) Death.
Description: Death is defined as all-cause mortalityMeasure: Death Time: Within 30 days
Description: Occurrence of mechanical ventilationMeasure: Mechanical ventilation Time: Within 14 days
Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2Measure: Occurrence of acute kidney injury Time: Within 14 days
Description: Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolicMeasure: Incidence of hypotension Time: Within 14 days
Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotensionMeasure: Incidence of hypotension requiring vasopressors Time: Within 14 days
Description: Outcome reported as the number of participants in each arm who experience sepsis, defined as the presence of at least 2 of the following clinical criteria together (qSOFA score): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or lessMeasure: Incidence of Sepsis Time: Within 14 days
Description: Hospital length of stay (days)Measure: Hospital length of stay Time: Within 14 days
Data processed on December 13, 2020.