COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45535

Dr Kshitij B Mody

joints.mody@gmail.com

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Males and Females of age 18 years or more diagnosed with Covid-19 infection by RT-PCR test method and not on Invasive Ventilatory Support. <br/ > <br/ >Subject willing to give written consent (Volunteer Information Sheet and Informed Consent Form) prior to enrolment in the study. <br/ > <br/ >Subjects must have clinically acceptable results for all the screening parameters.

Males and Females not proven to have Covid-19 infection by a positive RT-PCR test result. <br/ > <br/ >Males and Females having proven Covid-19 infection by positive RT-PCR test result but on Invasive Ventilatory Support. <br/ > <br/ >Subject deemed uncooperative or noncompliant.

1

Dr Bharat S Mody

18

90

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Reduction in laboratory values of the following inflammatory markers: ESR; CRP; Serum Ferritin; Serum Procalcitonin; Serum Lactate Dehydrogenase (LDH); and IL6 and improvement in clinical parameters. <br/ > <br/ >Reduction in laboratory values of the following coagulopathy marker: D Dimer <br/ > <br/ >Improvement in Clinical Parameters.Timepoint: 5 days

Not reported

[{"arm_notes": "", "treatment_id": 1213, "treatment_name": "Sodium bicarbonate", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]