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Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

NCT04366908 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2023-03-03

No results posted yet for this study

Summary

The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness.

As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.

Conditions

Interventions

DRUG

BAT + Calcifediol

The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule

DRUG

BAT

The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • Dynamic Solutions

    collaborator INDUSTRY

  • Faes Farma, S.A.

    collaborator INDUSTRY

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • José López Miranda, MD · Hospital Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2022-04-19
Completion
2022-04-19

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366908 on ClinicalTrials.gov