Cholecalciferol to Improve the Outcomes of COVID-19 Patients (CARED)

Vitamin D Study Group

Status and phase: Completed; Phase 4

Conditions: COVID

Treatments: Drug: Vitamin D; Drug: Placebo

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04411446

001

Details and patient eligibility

About

The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement.

Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D.

The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events.

To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo.

The trial has a sequential design with two steps:

• The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and
• If there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation.

All study outcomes will be measured during the index hospitalization.

Full description

See above.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SARS-CoV-2 confirmed infection;
• Admission to a hospital;
• Expected hospitalization in the center for at least for 24 hs;
• Oxygen Saturation >90% breathing without oxygen supplement;
• Age at least 45 years or the presence of one of the followings risk factors:
• Hypertension;
• Diabetes (type I o II);
• At least moderate COPD or Asthma;
• Cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery);
• Body Mass Index >=30;
• Signed Written consent.

Exclusion criteria

• <18 years old;
• Women in childbearing age;
• >= 72 hs since current admission;
• Requirement for high dose of oxygen (>5 liters/minute) or mechanical ventilation (non-invasive or invasive);
• History of Chronic kidney disease requiring hemodialysis or chronic liver failure;
• Inability for oral intake;
• Previous treatment with pharmacological vitamin D;
• History of:
• previous treatment with anticonvulsants;
• sarcoidosis;
• malabsorption syndrome;
• Known hypercalcemia.
• Life expectancy less than 6 months;
• Known allergy to the study medication;
• Any condition impeding to bring informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

5 capsules containing 100.000 UI of vitamin D each. The intervention will be 5 capsules given in one-time oral intake.

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

5 capsules containing placebo. The intervention will be 5 capsules given in one-time oral intake.

Treatment:

Drug: Placebo