SARS CoV 2 symptomatic disease
Conditions
Interventions
1. Study setting is COVID-19 treatment unit at Base Hospital-Homagama.
2. Simple randomization will be performed using computer generated random sequence allocation. Pre-defined group assignment for
Sponsors
Base Hospital, Homagama
Eligibility
Inclusion criteria
Inclusion criteria: - Male or female patients - Aged over 18 years - Having mild or moderate illness according to the National Institute of Health Classification system for SARS CoV -2 o Mild illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging. o Moderate illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) greater than or equal to 94% on room air at sea level. - Laboratory confirmed SARS-CoV-2 symptomatic infection - Availability of the patient for recruitment into the study within 96 hours of symptom onset - Normal corrected/ ionized calcium at the time of admission according to the reference range provided by the laboratory
Exclusion criteria
Exclusion criteria: - Pregnant and/or lactating women - Prior diagnosis of vitamin D deficiency (less than 20 ng/mL) - Being on vitamin D supplementation greater than 1000 IU/day within past 3 months: - Organ failure/ need for ICU stay/ organ support at the time of enrollment - Patients with any disorder related to calcium metabolism that in the opinion of the investigator does not justify a high dose of vitamin D - Patients who have been already enrolled in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-point ordinal scale for clinical improvement in COVID-19 [Ref: Ader, F. (2020) Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. BMJ open, 10(9), [Online] Available from: doi.org/10.1136/bmjopen-2020-041437.] will be used to define the primary outcome. The percentage of participants being in the first three categories will be calculated as the primary outcome measure. 1. Not hospitalised, no limitation on activities, asymptomatic 2. Not hospitalised, limitation on activities 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices 6. Hospitalised, on invasive mechanical ventilation or ECMO 7. Death. [Day 14 and 28 from date of admission] | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality [At 28 days of admission] iChange in the score of above ordinal scale from baseline to the worse score recorded [Number of points changed in the 7 point ordinal scale to the worse score which is indicated by the maximum score the patient gets] [ Until 28th day of admission] Confirmed viral clearance rate as defined by negative two consecutive SARS-CoV-2 PCR tests [8-10 days from onset of symptoms] Number of patients needing ICU stay, organ support- supplemental oxygen, ventilator, inotrope, dialysis [ Until 28th day of admission] % Change in qSOFA score [quick sequential organ failure assessment score] [From day 1 to day 7 of admission] Number of clinically detectable arterial/ vi. venous thrombo-embolic events; stroke, acute coronary events, acute limb ischemia, deep vein thrombosis, pulmonary thromboembolism [ At time of discharge] % Change in following inflammatory markers a. Full blood count- lymphocyte and neutrophil count b. CRP (C-reactive protein) c. Ferritin d. D-dimer e. IL-6 f. IL-1 beta [ From day 1 to day 8-10 of admission] Safety endpoints: i. Number of patients with hypercalcaemia [defined as serum corrected calcium above the reference range] ii. Gastrointestinal side effects: abdominal pain, nausea, vomiting, altered bowel habits any day following the initiation of intervention [ At day 8-10 of admission] | — |
Countries
Sri Lanka
Contacts
Public ContactManilka Sumanatilleke
Consultant Endocrinologist
Outcome results
None listed