COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59084

Amol Pendse

Rahul.Kodgule@glenmarkpharma.com

2021-08-05

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures <br/ >2. Age 18-70 years (inclusive) at the time of signing ICF <br/ >3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening. <br/ >4. Recent onset (within 72 hours of time of consent) symptoms of mild COVID 19 with oxygen saturation (SpO2 > 94 %) and respiratory rate < 24 breaths/min. <br/ >5. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test <br/ >6. Eligible subjects of child-bearing age (female or male with female partner of childbearing age) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ >7. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >

1. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >2. Subjects with infection requiring oxygen support, invasive or non-invasive ventilator support, extracorporeal membrane oxygenation (ECMO) or shock requiring vasopressor support. <br/ >3. Current known pneumonia based on x-ray or computed tomography (CT) scan or history of pneumonia within 3 months before screening. <br/ >4. Requiring hospitalization for the treatment of COVID-19 <br/ >5. Prolonged QT, defined as QTcF â?¥ 450 milliseconds for men and as QTcF â?¥ 470 milliseconds for women <br/ >6. Requires ICU care for management of ongoing clinical status. <br/ >7. Known allergy or hypersensitivity to Nitric Oxide Nasal Spray. <br/ >8. Asthma, allergic rhinitis or chronic obstructive lung disease <br/ >9. Pregnant or lactating women, <br/ >10. Having used Nitric Oxide Nasal Spray or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.

2

Glenmark Pharmaceuticals Ltd

18

65

India

Mild disease at enrollment

1: Mild disease at enrollment

306

Change from baseline in log viral load through Day 8Timepoint: Change from baseline in log viral load through Day 8

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "Nasal spray", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]