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Completed

NCT Number: NCT04411446

Cholecalciferol to Improve the Outcomes of COVID-19 Patients

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.

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Key information

Conditions

COVID Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Alta Complejidad en Red El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

5 capsules of 100.000 UI Vitamin D orally given all at once. One dose.

Other names: Cholecalciferol

Placebo

Drug

5 capsules of containing placebo orally given all at once. One dose.

Primary outcomes

  1. Respiratory SOFA.

    Time frame: One week

    Is the respiratory component of the sequential organ failure assessment score (SOFA score). It is a 4 points scale, each point indicate a deeper respiratory impairment. The score is based on the relationship between the arterial pressure of oxygen (PaO2) and inspired fraction of oxygen (FiO2), as the ratio of both (PaFi). In the cases were arterial blood gas are not measured, the pulse oximetry will be used instead.

    The respiratory SOFA is as follows:

    • 1: PaO2/FiO2 >=300;
    • 2: PaO2/FiO2 >=200 and <300;
    • 3: PaO2/FiO2 >=100 and <200;
    • 4: PaO2/FiO2 <100.

    The minimum respiratory SOFA score will be record on daily basis during first week or to death or discharge, whichever occur first.

    This outcome is the primary outcome of the first study phase.

  2. Need of a high dose of oxygen or mechanical ventilation.

    Time frame: 30 days

    The start of oxygen supplementation at FiO2 >40% or the initiation of invasive through orotracheal intubation) or non-invasive ventilation (Continuous positive airway pressure or Bilevel positive airway ventilation).

    This outcome will be recorded during hospitalization to 30 days, the death or discharge, whichever occur first.

    This is the primary outcome of the second study phase.

Secondary outcomes

  1. Change in oxygen saturation.

    Time frame: One week

    Difference between the oxygen saturation at study entry and the lowest oxygen saturation measured during the first week, the death or discharge, whichever occur first.

    The oxygen saturation will be measured by pulse oximetry using commercially available devices.

  2. Oxygen desaturation.

    Time frame: One week

    Oxygen saturation equal or less than 90% in any moment during the hospitalization. This outcome will be measured by pulse oximetry using commercially available devices.

    The outcome will be measured during the first week, the death or hospital discharge, whichever occur first.

  3. Change in Quick SOFA score.

    Time frame: 30 days.

    The difference between the Quick SOFA score at study entry and the highest value recorded during the hospitalization.

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  4. Myocardial infarction.

    Time frame: 30 days

    Myocardial infarction is defined as suspicious symptoms with new Q waves in the EKG and enzymatic elevations compatible with the Fourth MI Definition.

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  5. Stroke.

    Time frame: 30 days

    Stroke is defined as a focal neurological loss lasting >24 hs as reported by treating physician.

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  6. Acute kidney injury.

    Time frame: 30 days

    Acute kidney injury is defined as an increase of at least 50% in serum creatinine levels (as compared with any previous value during the hospitalization).

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  7. Pulmonary thromboembolism.

    Time frame: 30 days

    Pulmonary thromboembolism is defined as the presence of suspicious symptoms (i.e. dyspnea) confirmed with objective evidence of a thrombus in the pulmonary tree by CT or MRI or Pulmonary Angiography.

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  8. Combined endpoint (stroke, myocardial infarction, acute kidney injury and pulmonary thromboembolism.

    Time frame: 30 days

    Combined outcome of the aforementioned events, Stroke is defined as a focal neurological loss lasting >24 hs as reported by treating physician.

    Myocardial infarction is defined as suspicious symptoms with new Q waves in the EKG and enzymatic elevations compatible with the Fourth MI Definition.

    Pulmonary thromboembolism is defined as the presence of suspicious symptoms (i.e. dyspnea) confirmed with objective evidence of a thrombus in the pulmonary tree by CT or MRI or Pulmonary Angiography.

    Acute kidney injury is defined as an increase of at least 50% in serum creatinine levels (as compared with any previous value during the hospitalization).

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  9. Admission to ICU.

    Time frame: 30 days

    Admission to Intensive Care Unit due to clinical deterioration as judged by the treating physician.

    The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

  10. Invasive Mechanical Ventilation.

    Time frame: 30 days

    The start of mechanical ventilation invasive during the hospitalization until 30 days, the death or discharge whichever occur first.

  11. Hospital Length of Stay.

    Time frame: 30 days.

    Total duration of initial hospital stay in days. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

    In the cases with hospital stays longer than 30 days, it will considered as 30 days.

  12. ICU length of stay.

    Time frame: 30 days

    Total duration of initial ICU stay in days. The outcome will be measured during the hospitalization until 30 days, the death or discharge whichever occur first.

    In the cases with ICU stays longer than 30 days, it will considered as 30 days.

  13. Death

    Time frame: 30 days.

    Death of any cause during the hospitalization until 30 days or discharge whichever occur first.

Sponsors and collaborators

Lead sponsor

Vitamin D Study Group

Network

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study title

Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients

Acronym: CARED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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