COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50753

Dr Vijender Singh Beniwal

info@pharexcelconsulting.com

2020-12-31

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Either male or female of age range 18-65 years <br/ >2. Patients with mild to moderate COVID-19 infection and RT-PCR confirmed diagnosis of COVID-19. <br/ >3. Subjects willing to give written informed consent and come for a regular follow up. <br/ >4. Subjects willing to abide by and comply with the study protocol.

1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer). <br/ >2. Presence of acute hypoxic respiratory failure <br/ >3. Requires Intensive care unit (ICU) care for management of ongoing clinical status <br/ >4. Severe infection, defined as need for invasive or non-invasive ventilator support <br/ >5. Inability to intake or tolerate oral medication <br/ >6. Category 6 or 5 based on modified 7-category ordinal scale of clinical status <br/ >7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission <br/ >8. Pregnant or lactating subjects <br/ >9. With any secondary complication such as diabetes, cancer, HIV or hypertension.

2

LIFECARE NEURO PRODUCTS LTD

18

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

45

Changes in clinical cure based on clinicianâ??s global assessment of symptomsTimepoint: Day 1; Day 7; Day 14 and Day 28

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 551, "treatment_name": "Gold immuno booster", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]