COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2021-019

Manilka Sumanatilleke

manilkasumana@gmail.com

2021-07-14

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

- 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

- 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

2

Base Hospital; Homagama

18

100

Sri Lanka

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

258129

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; asymptomatic2. 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]

Phase 2

[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]