COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55910

Dr Cecil Ross

cecil.ross@stjohns.in

2021-11-18

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Hospitalized adult age 18 to 70 years <br/ > 2.Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay <br/ > 3.Moderate Covid-19 patients not requiring organ support <br/ > 4.Mild Covid requiring hospitalization <br/ > 5 Duration of Hospital less than 48 hours. <br/ >

1. Unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours <br/ > 2. Requiring organ support at screening (Organ support defined as need for ICU care, mechanical ventilation, Non Invasive Ventilation (NIV), High flow Nasal Oxygen at screening <br/ > 3. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ > 4. Known hypersensitivity to the trial drug or its components <br/ > 5. Pregnant women or women who are breastfeeding <br/ > 6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment <br/ > 7. Unable to provide consent <br/ >

2

Rajiv Gandhi University of Health Sciences

18

70

India

Moderate disease at enrollment

3: Moderate disease at enrollment

100

1.Need for Organ Support <br/ >2.All-cause Mortality at 28 days <br/ > <br/ >Timepoint: 1.All-cause Mortality at 28 days <br/ > <br/ >

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

Not reported

[{"arm_notes": "", "treatment_id": 850, "treatment_name": "N-acetylcysteine", "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"}]