Status:
COMPLETED
Cholecalciferol to Improve the Outcomes of COVID-19 Patients
Lead Sponsor:
Vitamin D Study Group
Collaborating Sponsors:
Agencia Nacional de Investigación y Desarrollo
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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-...
Detailed Description
See above.
Eligibility Criteria
Inclusion
- 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
- \<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.
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2021
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04411446
Start Date
August 11 2020
End Date
July 28 2021
Last Update
July 30 2021
Active Locations (1)
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1
Hospital de Alta Complejidad en Red El Cruce
San Juan Bautista, Buenos Aires, Argentina, 1888