Cri Analog PG1 Effectiveness and Safety in Covid-19

NCT04536363 | Withdrawn Phase 2 DMC

• 1 other identifier: CEIS-2020-089
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Covid19

Keywords

Prostaglandin E1; COVID-19; ARDS; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death during or at the end of the intervention

  6 month

Secondary Outcomes (6)

• Hypoxemia Resolution

  6 month

• Days from admission to intensive care unit and administration of ANALOG PGE1

  6 month

• ICU stay

  6 month

• Days with high flow oxygen

  6 month

• Days of invasive mechanical ventilation prior to administration of PGE1 ANALOG

  6 month

Study Arms (2)

Standard therapeutic protocol

ACTIVE COMPARATOR

1. Dexamethasone (4mg ampoule, intravenous) 2. Tocilizumab (8 mg / kg (maximum dose 800 mg) IV, maximum 3) 3. Empirical Antibiotic Therapy in patients with suspected pneumonia (according to management guidelines) 4. Enoxaparin (40mg prefilled syringe) 5. Enoxaparin (20mg, 40mg, 60mg, 80mg prefilled syringe) 6. Low molecular weight heparin (5000IU prefilled syringe)

Drug: Standard therapeutic protocol

Standard Therapeutic Protocol + PGE1 Analog

EXPERIMENTAL

Analog of PGE1 + Standard therapeutic protocol Standard medical treatment: 1. Dexamethasone (4mg ampoule, intravenous) 2. Tocilizumab (8 mg / kg (maximum dose 800 mg) IV, maximum 3) 3. Empirical Antibiotic Therapy in patients with suspected pneumonia (according to management guidelines) 4. Enoxaparin (40mg prefilled syringe) 5. Enoxaparin (20mg, 40mg, 60mg, 80mg prefilled syringe) 6. Low molecular weight heparin (5000IU prefilled syringe)

Drug: Analogs, Prostaglandin E1; Drug: Standard therapeutic protocol

Interventions

Analogs, Prostaglandin E1 DRUG

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 Therapeutic Protocol + PGE1 Analog

Standard therapeutic protocol DRUG

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

Standard Therapeutic Protocol + PGE1 Analog; Standard therapeutic protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years of age
• COVID19 diagnosis:
• RT PCR for COVID-19 positive in respiratory tract sample (nasopharyngeal swab, sputum, bronchoalveolar lavage)
• At least 2 of the following symptoms: cough, odynophagia, dyspnea, asthenia, adynamia, gastrointestinal symptoms.
• Findings compatible with viral pneumonia on chest tomography or chest radiography.
• Risk of respiratory deterioration given by at least 1 of the following:
• Hypoxemia: PaO2 \<60 mmHg, SaO2 \<90% or supplemental O2 requirement to maintain SaO2\> 90%
• Call Score ≥ 9 points
• FR\> 30 / min
• PaO2 / FiO2 less than 200
• Intubated patients without deterioration of other organs (without acute kidney injury, without elevated transaminases).
• Progression of radiological findings of pneumonia.
• Patients with moderate or severe oxygenation disorder, with diaphragm of 200-100 and \<100 respectively, who require supplemental oxygen at high flow (non-rebreathing mask or high flow cannula).
• Complete record of medical history, allergies, and medical conditions that preclude the use of prostaglandin E1 analogs have been ruled out.
• Voluntary participation in the study, demonstrating fullness through informed consent.

You may not qualify if:

• Allergy or sensitivity to PEG1 analog or components
• Arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean arterial pressure less than 65mm of mercury or BP requirement \<80/50 mmHg or TAM 60 mmHg with norepinephrine requirement greater than 0.1 mcg / kg / min
• Severe hypertension defined as systolic blood pressure greater than or equal to 180 mm of mercury and / or diastolic blood pressure greater than or equal to 110 mm of mercury
• Bradycardia defined as heart rate less than 60 beats per minute
• Previous events of priapism or penile anatomical changes
• Sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism
• Hemorrhagic diathesis
• Active peptic ulcer, trauma, or recent brain hemorrhage.
• Abnormal pulmonary venous return with obstruction
• Pregnancy: A pregnancy test will be performed upon admission of the patient to the study (if applicable).
• Heart failure with NYHA functional class\> 1
• Hemodynamically relevant arrhythmia: That generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output
• Mitral and / or aortic stenosis and / or insufficiency of either
• Unstable angina
• Acute Myocardial Infarction in the last 6 months

Sponsors & Collaborators

• Alonso Vera Torres: lead

MeSH Terms

Conditions

COVID-19

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There are no masking techniques in assigning treatment to patients, as this is an open study. Nor is any procedure for urgently opening emergency codes applicable. The statistical analysis will be carried out without the epidemiologist in charge knowing or being able to identify the group of origin of the patients (control / intervention). To guarantee this, the data of the patients will be reported to the epidemiologist without any identification data and through a code whose sole knowledge at the time of delivery will be the responsibility of the principal investigator. Interim comparisons and analysis will be carried out for mortality and adverse events in the following follow-up stages according to the number of patients achieved: 20%, 40%, 60%, 80% and final.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trasplantation surgery

Model Details: Study type: Open randomized clinical trial. Study phase: Phase II Design: Experimental in parallel Two management groups Intermediate analysis will be carried out when completing 20%, 40%, 60% and 80% of the planned sample. All adjusted statistical analysis will be carried out conditionally, predicting the effect of the stratification of the randomization process. The statistical analysis will be carried out in accordance with the principle of "intention to treat"

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 2, 2020
• Study Start: December 3, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: September 15, 2023

Record last verified: 2023-09