COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46899

Dr Shyam Sundar Varaprasad Raju

drgsgmbbs@gmail.com

2020-12-29

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Patients aged above 18 years either gender with positive RT-PCR for novel Corona Virus causing Covid-19 pandemic. <br/ >2.Only patients categorized as suffering from uncomplicated illness (category 1), mild pneumonia (category 2) and severe pneumonia (category 3) as defined by ICMR dt. 31-03-2020, will be selected to participate in the study. <br/ >3.Women of childbearing potential must agree to use contraception for the duration of the study. <br/ >4.Patients or their legally acceptable representative willing to sign the informed Consent form.

1. Patients less than 18 years of age. <br/ >2. Patience who have taken high dose vitamin D (i.e.60,000 IU of Vitamin D) In the last 3months either daily, Weekly or monthly or whose 25 (OH) D level is above 30 ng/ml. <br/ >3. Refusal to participate expressed by patient or legally authorised representative if they are present. Refusal to sign the informed Consent form. <br/ >4. Patients of category 4, 5, 6 ( ARDS, Sepsis, Septic Shock) Respectively as a defined by ICMR. <br/ >5. Patients suffering from active malignancy. <br/ >6. Severe chronic kidney disease or requiring dialysis ( i.e. eGFR <30 mL/min). <br/ >7. Pregnancy and breast-feeding. <br/ >8. Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >9. Contraindication to any study medication including allergy. <br/ >10. Human immunodeficiency virus infection under highly active antiretroviral therapy ( HAART). <br/ >

2

Pulse Pharmaceuticals Pvt Ltd

18

90

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

1. Difference in two study groups with respect to the duration and severity of signs and symptoms. <br/ >2. Time taken for Double negative RT-PCR between the two study groups <br/ >3. Duration of hospital stay. <br/ >4. Difference in the blood parameters and comparable symptoms between the two groups after the intervention.Timepoint: 24 weeks

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

Phase 3/Phase 4

[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]