COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46392

Dr Dhananjay Lad

laddhl@gmail.com

2020-09-22

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Patients of both Gender aged more than 18 years old. <br/ >2.Willing and able to provide written informed consent. <br/ >3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test <br/ >4.Currently hospitalized and requiring medical care for COVID-19 <br/ >5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening <br/ >

1.Subjects having less than 18 years of age <br/ >2.Drug atopy subjects <br/ >3.Private positive patients/ Truenaat positive/ Antigen positive <br/ >4.Critical comorbities

2

Public Health Department

18

100

India

Moderate disease at enrollment

3: Moderate disease at enrollment

30

Compared to standard of treatment receiving in COVID -19 infection; proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .Timepoint: 14 Days

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

Phase 3

[{"arm_notes": "", "treatment_id": 1439, "treatment_name": "Cefixime+ivermectin+montelukast", "treatment_type": "Antibiotics+antiparasitics+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"}]