Covid19Phase 2PGE1-COVID19NCT04536363
Cri Analog PG1 Effectiveness and Safety in Covid-19
A Phase 2 study testing Analogs, Prostaglandin E1 and Standard therapeutic protocol in people with Covid19, run by Alonso Vera Torres.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Analogs, Prostaglandin E1 and Standard therapeutic protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2020to 3 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
- Ischemic or hemorrhagic cerebrovascular event in the last 6 months
- Child B or C or decompensated liver cirrhosis
- Chronic kidney disease in renal replacement therapy
- Serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study
About this study
Official title: Effectiveness and Safety of the Administration of Intravenous Prostaglandin E1 Analog in the Reduction of Mortality and Complications of Patients With COVID-19
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
Read the detailed description
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
- Conditions
- Covid19
- Being tested
- Analogs, Prostaglandin E1, Standard therapeutic protocol
- Keywords
- Prostaglandin E1, COVID-19, ARDS, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analogs, Prostaglandin E1Drug
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 protocolDrug
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:
- Dexamethasone (4mg ampoule, intravenous) Dose: 6mg intravenous every day for a maximum of 10 days
- Tocilizumab Dose: 8 mg / kg (maximum dose of 800 mg) IV, maximum 3 doses 8 to 12 hours apart
- Empirical Antibiotic Therapy in patients with suspected pneumonia (according to management guidelines)
- Enoxaparin (40mg prefilled syringe) Dose: 40mg subcutaneously every 24 hours
- Enoxaparin (20mg, 40mg, 60mg, 80mg prefilled syringe) Dose: 1mg / kg every 12 hours
- Low molecular weight heparin (5000IU prefilled syringe) Dose: 5,000 IU subcutaneous every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Analogs, Prostaglandin E1; Drug: Standard therapeutic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death during or at the end of the intervention
Measured: 6 month
Secondary outcomes (6)
Hypoxemia Resolution
Sat O2> 90% to the environment
Measured: 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
Measured: 6 month
ICU stay
Specify number of days of ICU stay
Measured: 6 month
Days with high flow oxygen
Record days that the patient has received oxygen through a high flow system
Measured: 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
Measured: 6 month
Evolution time of the disease
Time from the onset of symptoms to the day of admission
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start3 Dec 2020
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Why it stopped: Delays in approval by the national regulatory authority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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"
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alonso Vera Torres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alonso Vera Torres, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536363
- Sponsor's protocol ID
- CEIS-2020-089
- Acronym
- PGE1-COVID19
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Administration of Intravenous Prostaglandin E1 Analog in the Reduction of Mortality and Complications of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04536363
- Acronym / sponsor ID
- PGE1-COVID19 / CEIS-2020-089
- Conditions
- Covid19
- Keywords
- Prostaglandin E1, COVID-19, ARDS, Mortality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delays in approval by the national regulatory authority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alonso Vera TorresUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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"
| Arm | Type | Receives |
|---|---|---|
| Standard therapeutic protocol | Active comparator | Drug: Standard therapeutic protocol1. 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) |
| Standard Therapeutic Protocol + PGE1 Analog | Experimental | Drug: Analogs, Prostaglandin E1, Drug: Standard therapeutic protocolAnalog 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient older than 18 years of age
- COVID19 diagnosis:
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analogs, Prostaglandin E1Analog 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 | Drug | Standard Therapeutic Protocol + PGE1 Analog |
| Standard therapeutic protocolStandard 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 | Drug | Standard Therapeutic Protocol + PGE1 Analog, Standard therapeutic protocol |
Primary outcome
Mortality
Time frame: 6 month
Death during or at the end of the intervention
6 secondary outcomes
Hypoxemia Resolution
Time frame: 6 month
Days from admission to intensive care unit and administration of ANALOG PGE1
Time frame: 6 month
ICU stay
Time frame: 6 month
Days with high flow oxygen
Time frame: 6 month
Days of invasive mechanical ventilation prior to administration of PGE1 ANALOG
Time frame: 6 month
Evolution time of the disease
Time frame: 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Analogs, Prostaglandin E1 and Standard therapeutic protocol in people with Covid19, run by Alonso Vera Torres.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.