Prevention and treatment with Calcifediol of respiratory problems caused by COVID-19

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Severe Acute Respiratory Syndrome in subjects with COVID-19

• Registration Number: EUCTR2020-001717-20-ES
• Lead Sponsor: Fundación para la Investigación Biomédica de Córdoba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1008

Inclusion Criteria

1. Age = 18 and <90 years
2. Diagnosis confirmed by COVID-19 PCR
3. Radiological image compatible with inflammatory pleuropulmonary exudate
4. Signature of direct or delegated informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

1. Being on treatment with Calcifediol or Colecalciferol in any of its presentations and dosage
2. Intolerance or allergy to Calcifediol or its components
3. Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified