The Clinical trial aim to evaluate the effectiveness and safety of the administration of the intravenous prostaglandin E1 analog in the reduction of mortality and complications of patients with COVID-19 diagnosis. Therefore the investigators propose an open randomized clinical trial in the Fundación Santa Fe de Bogota
COVID-19 is a public health problem that has spread throughout the world and has forced different scientific societies to consider effective measures to control the increasing spread of the disease. This disease is presumed to follow a virologic pattern similar to SARS-CoV-1 (Severe acute respiratory syndrome coronavirus 1) . The disease spectrum includes asymptomatic stage and pre-symptomatic , mild infection uncomplicated, mild and severe pneumonia and the acute Respiratory distress syndrome (ARDS) constituting the point of no return characterized by ventilatory mechanics preserved with severe refractory hypoxemia. The pulmonary involvement of patients with COVID-19 causes an endothelial injury, which can be associated with changes in vascular permeability, manifesting as thrombotic, venous and arterial disease in patients with COVID-19. Alprostadil, a prostaglandin E1 analog that has a vasodilator mechanism, inhibitory property of platelet aggregation and inducer of bronchodilation, promises to prevent complications of SARS-CoV2. In addition to that Alprostadil has been used in other clinical trials as treatment for the acute respiratory distress syndrome caused by Influenza, in which it showed no harm or benefit, nonetheless the pathophysiology of the acute distress respiratory syndrome caused by Influenza and COVID-19 are similar in macroscopic changes but very different in microscopic changes which is why it is important to evaluate the effectiveness and safety of the administration of intravenous prostaglandin E1 analog in the reduction of mortality and complications of patients with COVID-19 diagnosis. Therefore the investigators propose an open randomized clinical trial, where patients in the intensive care unit of the Fundación Santa Fe de Bogotá are randomized into two groups, where one is going to be treated with standardized treatment after the guidelines recommendations of the Colombian Infectology Society and the other one is going to receive the same standardized treatment and Alprostadil infusion for a maximum of 7 days. During the infusion of the Alprostadil the patient will be carefully monitored by the intensive care unit team. After the Infusion the patient will be followed up for 30 days in which the mortality and hypoxemia resolution will be monitored. Key words: COVID-19, Prostaglandin E1 Analogue, Alprostadil, Mortality, Acute respiratory distress syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Analog of PGE1: Infusion starting dose: 0.05 -0.01 mcg per kilogram of weight per minute in infusion continues, maximum 7 days, until achieving the desired clinical response (increase in PaO2), at that time decrease the infusion rate to the lowest dose possible to keep answer. This can be accomplished by decreasing the dose from 0.1 to 0.05 to 0.025 to 0.01 mcg / kg / min. If the response to 0.05 mcg / kg / min is inadequate, the dose can be increased to 0.4 mcg / kg / min, although in general high doses do not produce better effects. Maximum continuous infusion for up to 7 days
Standard medical treatment is governed by current recommendations of national scientific societies and the Ministry of Health and Social Protection and may be modified throughout the course of the study according to the available evidence. In addition, the criteria of the treating physician are taken into account. Among the alternatives proposed by the current clinical practice guidelines are: 1. Dexamethasone (4mg ampoule, intravenous) Dose: 6mg intravenous every day for a maximum of 10 days 2. Tocilizumab Dose: 8 mg / kg (maximum dose of 800 mg) IV, maximum 3 doses 8 to 12 hours apart 3. Empirical Antibiotic Therapy in patients with suspected pneumonia (according to management guidelines) 4. Enoxaparin (40mg prefilled syringe) Dose: 40mg subcutaneously every 24 hours 5. Enoxaparin (20mg, 40mg, 60mg, 80mg prefilled syringe) Dose: 1mg / kg every 12 hours 6. Low molecular weight heparin (5000IU prefilled syringe) Dose: 5,000 IU subcutaneous every 12 hours
Mortality
Death during or at the end of the intervention
Time frame: 6 month
Hypoxemia Resolution
Sat O2\> 90% to the environment
Time frame: 6 month
Days from admission to intensive care unit and administration of ANALOG PGE1
Number of days from admission to intensive care unit until administration of ANALOG PGE1
Time frame: 6 month
ICU stay
Specify number of days of ICU stay
Time frame: 6 month
Days with high flow oxygen
Record days that the patient has received oxygen through a high flow system
Time frame: 6 month
Days of invasive mechanical ventilation prior to administration of PGE1 ANALOG
Number of days during which the patient was under invasive or non-invasive mechanical ventilation prior to the administration of PGE1 ANALOG
Time frame: 6 month
Evolution time of the disease
Time from the onset of symptoms to the day of admission
Time frame: 6 month
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