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

Patient testing positive RT PCR for novel Corona Virus causing Covid-19 will be classified into 6 categories as per the Directorate General of Health Services, Government of India Guidelines dated 31-03-2020, given below.

1. Uncomplicated Illness: Fever, sore throat, cough, nasal congestion, malaise, headache, anosmia, chills, nausea, vomitings, diarrohea etc.

2. Mild Pneumonia: Patients with no signs of severe pneumonia

3. Severe Pneumonia: Fever with suspected respiratory infection plus one of the following: respiratory rate >30 breaths/min, severe respiratory distress, SpO2<90%on room air.

4. New or worsening respiratory symptoms within 1 week of known clinical insult with  abnormal chest imaging ( X ray, CT or Ultrasound) with bilateral opacities not fully explained by effusions, lobar or lung collapse or nodules.

5. Sepsis: Signs of organ dysfunction like altered sensorium, difficulty or fast breathing, low O2 saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure, skin mottling, laboratory evidence of coagulopathy, thrombocytopenia, acidosis, high lactate or hyperbilirubinemia.

6. Septic shock: Persistant hypotension despite volume resuscitation, requiring vasopressors to maintain mean arterial pressure ≥65 mmHg and serum lactate <2 mmol/L

Only patients falling in either Category 1 (Uncomplicated Illness) or Category 2 (Mild Pneumonia) will be recruited in the study. Written informed consent in the IEC approved format shall be taken after explaining the study in the colloquial language understandable to the patient if fit to do so or the legally authorized representative of the patient. Then the patient will be randomized into one of the two groups viz., Group 1/ND group (Active Comparator) or Group 2/D Group (Experimental Treatment) using a simple computer-generated randomization chart.

Adequate venous blood sample shall be collected for Hemoglobin, WBC count, Hematocrit, Platelets, Total Bilirubin, creatinine, Sodium, Potassium, Chloride, CRP, LDH, IL-6, Ferritin, 25(OH)D, and Calcium, and others as required for a given patient. Repeat estimations will be undertaken at the completion of vitamin D (Pulse D Therapy) for the respective categories. Interim Blood tests as required shall be conducted as per the requirement of such case as on that day of evaluation.

All the data shall be collected in a pre-approved proforma for each patient including vitamin D status.

Outcome Measures:

Primary Outcome Measure

1. Difference in two study groups with respect to the duration and severity of  signs and symptoms.  [Time Frame: Through study completion]
2. Duration of hospital stay [Time frame: Through study completion]
3. Difference in the blood parameters and comparable symptoms between the two groups after the intervention.

Secondary Outcome Measures:

1. Intensive care unit admission [Time frame: Through study completion]
2. Recovery [Time Frame: Through study completion]
3. Composite of cumulative death, i.e., all causes and specific causes mortality.

**Statistical Analysis:**The data would be analyzed using suitable statistical tools to determine the significance of difference in values so obtained. Descriptive statistics (n, Mean, Standard Error of Mean (SEM) / Standard Deviation (SD) & Range) will be presented for all continuous variables. P value < 0.05 will be as taken as statistically significant. Paired Student’s T-test, Independent sample T-test will be used for comparisons of two groups and one/two-way analysis of variance (ANOVA) will be done for multiple comparisons.