COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001747-21/PT

Instituto de Saúde Pública Universidade Porto - Clinical trials information

secretaria@ispup.pt

2020-05-22

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Admitted to a hospital with a diagnosis of moderate or severe COVID-19 pneumonia defined as: a. moderate cases: showing fever and respiratory symptoms with radiological findings of pneumonia, b. severe cases meeting any of the following criteria: i) respiratory distress (≧30 breaths/ min), ii) oxygen saturation≤93% at rest without oxygen inhalation, iii) PaO2/FiO2(fraction of inspired oxygen)≤300mmHg, iv) with chest imaging that showed obvious lesion progression within 24-48 hours >50% shall be managed as severe cases 2. Subject, or legally authorized representative, provides written informed consent prior to the initiation of any study procedures. 3. Understands and agrees to comply with planned study procedures. 4. Agrees to the collection of oropharyngeal swabs. 5. Male or non-pregnant female adult > / = 18 years of age at the time of enrollment. 6. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen collected < 72 hours prior to randomization. Note, 72 hours is not necessarily time from initial diagnosis. If > / = 72 hours since positive PCR, the PCR may be repeated to assess eligibility. 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.

1. Admitted to a hospital with a diagnosis of critical type of COVID-19 pneumonia defined as any of the follow: i) requiring mechanical ventilation, ii) extracorporeal life support (ECMO, ECCO2R, RRT), iii) shock, iv) multiple organ dysfunction syndrome. Patients who are participating in another drug clinical trials. 2. Requiring dialysis. 3. Pregnancy or breast feeding. 4. Allergy to any study medication. 5. Severe basic diseases that affect survival, including uncontrolled malignant tumors that have metastasized and cannot be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc., 6. Pulmonary tumors caused by obstructive pneumonia, severe interstitial fibrosis, alveolar proteinosis, allergic alveolitis. 7. Continued use of immunosuppressive agents or organ transplants in the last 6 months. 8. Expected deaths within 48 hours. 9. Clinicians judge inappropriate.

2

Instituto de Saúde Pública Universidade Porto

18

65

Portugal

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

160

Improvement of COVID-19 disease status defined by the percentage of subjects reporting each severity rating on an 8-point ordinal scale [Time Frame: Day 29] The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death, 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4) Hospitalized, requiring supplemental oxygen, 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise), 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care, 7) Not hospitalized, limitation on activities and/or requiring home oxygen, 8) Not hospitalized, no limitations on activities.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 4

[{"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]