Efficacy and safety of Montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19)

Phase 1

• Conditions: ovel coronavirus pneumonia (COVID-19); MedDRA version: 23.0Level: LLTClassification code 10084383Term: Novel COVID-19-infected pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001747-21-PT
• Lead Sponsor: Instituto de Saúde Pública Universidade Porto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified