Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT06585995
Eligibility Criteria:
Inclusion Criteria:
1. Patients hospitalized for severe COVID-19 clinical presentation in the "early stage," with a maximum of 9 days after the onset of the first symptoms and who have not progressed to the "active phase" (fever, cough, sore throat, diarrhea, loss of taste or smell, oxygen saturation \<92%, PaO2 / FiO2 \<300 mmHg, respiratory rate \>30 breaths per minute, or pulmonary infiltrates \>50%).
2. Patients older than 18 years and younger than 65 years who have received at least 2 doses of the COVID-19 vaccine.
3. Patients who agree to participate at the time of hospitalization and sign the informed consent.
4. Patients with 25(OH)D levels below 40 ng/ml and without contraindications for Vitamin D3 supplementation.
Exclusion Criteria:
1. Patients who, at the time of recruitment, have another comorbidity as the primary condition for which they were hospitalized and that places them at high risk of death (e.g., terminal cancer, postoperative patients, renal failure, liver disease, uncontrolled diabetes, patients with HIV, CMV, tuberculosis, traumatic brain injury, shock from any cause, etc.).
2. Pregnant or breastfeeding patients.
3. Patients who have received Vitamin D3 supplements greater than 800 IU/day, 15 days before recruitment.
4. Patients with contraindications for Vitamin D3 supplementation, such as active granulomatous diseases (sarcoidosis, tuberculosis, lymphoma, Vitamin D3 metabolism disorders, hypercalcemia).
5. History of kidney stones.
6. Known Vitamin D3 hypervitaminosis or hypercalcemia.
7. Known intolerance to Vitamin D3.
8. Patients with extrapulmonary organ failure.
9. Patients with 25(OH)D levels equal to or greater than 40 ng/ml.
10. Patients who, at the time of recruitment, exhibit clear signs of "critical illness" due to COVID-19, such as organ failure requiring intensive care admission or who meet the criteria for mechanical ventilation due to oxygen desaturation: PaO2 \<60 mmHg (after supplemental oxygen), SpO2 \<88% (after supplemental oxygen), PaCO2 \>50 mmHg with pH \<7.32.
Elimination Criteria:
1. Patients who require major surgery after recruitment.
2. Patients who develop contraindications to standard COVID-19 treatment.
3. Patients who die before completing the three blood sample collections.
4. Patients who receive an IL-6 blocking drug.
5. Patients who develop clinical conditions that prevent blood sample collection or for whom medical recommendations advise against blood sample collection.
6. Patients who withdraw their consent to continue participating in the study.
7. Patients who develop adverse reactions secondary to Vitamin D3 administration, requiring the suspension of Vitamin D3, such as severe hypercalcemia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06585995
Study Brief:
Protocol Section:
NCT06585995