Cri Analog PG1 Effectiveness and Safety in Covid-19

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alonso Vera Torres
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Allergy or sensitivity to PEG1 analog or components

2. 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

3. 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

4. Bradycardia defined as heart rate less than 60 beats per minute

5. Previous events of priapism or penile anatomical changes

6. Sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia predisposing to priapism

7. Hemorrhagic diathesis

8. Active peptic ulcer, trauma, or recent brain hemorrhage.

9. Abnormal pulmonary venous return with obstruction

10. Pregnancy: A pregnancy test will be performed upon admission of the patient to the study (if applicable).

11. Heart failure with NYHA functional class> 1

12. Hemodynamically relevant arrhythmia: That generates hypotension, chest pain, dysfunction, sensory disturbance or other signs of low output

13. Mitral and / or aortic stenosis and / or insufficiency of either

14. Unstable angina

15. Acute Myocardial Infarction in the last 6 months

16. Ischemic or hemorrhagic cerebrovascular event in the last 6 months

17. Child B or C or decompensated liver cirrhosis

18. Chronic kidney disease in renal replacement therapy

19. Serious medical condition or laboratory findings that, in the investigator's judgment, may compromise patient safety during participation in the study