COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48850

Dr Bhupesh Dewan

Bhupesh.Dewan@zuventus.com

2021-01-28

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR. <br/ >2. Patients with moderate COVID-19 (According to Clinical Management Protocol: COVID 19, Govt. of India). <br/ >-Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air <br/ >-Respiratory Rate â?¥24 per minute <br/ >-Pneumonia with no signs of severe disease <br/ >3. Symptomatic adult male or non-pregnant female (â?¥18 years) <br/ >4. Voluntarily participating in the clinical study and patients or legal representative willing to sign informed consent.

1. Asymptomatic COVID-19 patients. <br/ >2. Patients with known hypersensitivity to glutathione or related drugs. <br/ >3. Patients enrolled in any other investigational drug studies in COVID-19. <br/ >4. Severe infection and need for invasive or non-invasive ventilator support. <br/ >5. Pregnant or lactating women

2

Zuventus Healthcare Limited

18

100

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

240

Proportion of patients showing clinical improvement on the WHO 7-point ordinal scale.Timepoint: Day 1; 2; 3; 4; 5; 6 and 7

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

Phase 3

[{"arm_notes": "", "treatment_id": 547, "treatment_name": "Glutathione", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]