COVID-19 Clinical Trial
— COVID-VIT-DOfficial title:
Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias
Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU
of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to
treat COVID 19).
Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are
evaluated.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2020 |
Est. primary completion date | September 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - > 18 year - Diagnosis of COVID-19 - Accept to participate in the study ( consent) Exclusion Criteria: - Pregnancy - Allergy to vitamin D - Consumption of any form of vitamin D during the last 3 months - Expected fatal outcome in the next 24 hours - Cognitive deterioration |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Investigación Biosanitaria del Principado de Asturias | Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Percentage of patients dying during hospitalization | Time to death or hospital discharge in days (average 12 days) | |
Primary | Admission to Intensive Care Unit (ICU) | Percentage of patients admitted to ICU and time in ICU | Time from hospital admission to discharge in days (average 12 days) | |
Primary | Time of hospitalization | Number of days from hospital admission to discharge | Time of hospitalization in days (average 12 days) | |
Primary | Clinical changes | Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...) | At the time of hospital admission and discharge (average 12 days) | |
Primary | Radiological changes | Changes in the percentage of patients with radiological findings of pneumonia and severity | At the time of hospital admission and discharge (average 12 days) | |
Primary | Calcidiol changes | Calcidiol levels in ng/mL. | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | Inflammation markers changes (CRP) | C-reactive protein (CRP) in mg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | Inflammation markers changes (IL-6) | Interleukin-6 (IL-6) in pg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | Inflammation markers changes (Leucocytes) | Leucocytes in cells per liter | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | Inflammation markers changes (D-dimer) | D-dimer in µg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Creatinine) | Creatinine in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Ferritin) | Ferritin in µg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Bilirubin) | Bilirubin in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Albumin) | Albumin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Haemoglobin) | Haemoglobin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (HDL cholesterol) | High density lipoprotein (HDL cholesterol) in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Procalcitonin) | Procalcitonin in ng/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Protonin) | Protonin in ng/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Calcium) | Calcium in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (Phosphate) | Phosphate in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | |
Primary | General biochemical parameters changes (pO2) | pO2 in mmHg | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|