NCT04366908

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

Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

• SARS-CoV 2
• COVID19
• SARS (Severe Acute Respiratory Syndrome)
• Cytokine Release Syndrome
• Cytokine Storm

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-05-07
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2020-04-29
• Last updated: 2023-03-03

Locations

1 site across 1 country: Spain