MedPath

To Study the Role of Vitamin D in the Treatment of Confirmed COVID-19 Infectio

Phase 3
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: O- Medical and SurgicalHealth Condition 3: B338- Other specified viral diseases
Registration Number
CTRI/2020/12/030083
Lead Sponsor
Pulse Pharmaceuticals Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients aged above 18 years either gender with positive RT-PCR for novel Corona Virus causing Covid-19 pandemic.

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.

3.Women of childbearing potential must agree to use contraception for the duration of the study.

4.Patients or their legally acceptable representative willing to sign the informed Consent form.

Exclusion Criteria

1. Patients less than 18 years of age.

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.

3. Refusal to participate expressed by patient or legally authorised representative if they are present. Refusal to sign the informed Consent form.

4. Patients of category 4, 5, 6 ( ARDS, Sepsis, Septic Shock) Respectively as a defined by ICMR.

5. Patients suffering from active malignancy.

6. Severe chronic kidney disease or requiring dialysis ( i.e. eGFR <30 mL/min).

7. Pregnancy and breast-feeding.

8. Anticipated transfer to another hospital which is not a study site within 72 hours.

9. Contraindication to any study medication including allergy.

10. Human immunodeficiency virus infection under highly active antiretroviral therapy ( HAART).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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