DALIA Study

Phase 2

Not yet recruiting

• Conditions: COVID-19 respiratory distress; COVID-19; Severe Acute Respiratory Syndrome; Betacoronavirus; Coronaviridae Infections; Coronavirus Infections; SARS Virus; Respiratory Tract Diseases

• Registration Number: RPCEC00000330
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Study Completion: 2020-10-30
• Results First Posted: 2020-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients aged = 18 years.
2) Virological diagnosis by RT-PCR of infection to SARS-CoV-2.
3) Patients in serious or critical condition.
4) Acute respiratory failure according to clinical and Berlin criteria (imaging and oxygenation).
5) Voluntariness of the patient through informed consent.

Exclusion Criteria

1) Previous treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6, IL-1 inhibitor (Anakinra).
2) Patients with kidney disease on hemodialysis.
3) Patients who previously indicate NO intubation, NO resuscitation.
4) Known hypersensitivity to any of the components of the formulations under study.
5) Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Mortality on discharge from the Hospital (Proportion of patients who die (global and by strata: serious and critical) according to their causes and treatment groups, during their stay at the CMN Siglo XXI Specialty Hospital). Measurement time: during hospital stay.<br>2) Need for invasive mechanical ventilation (orotracheal intubation) in critically ill patients and, time (in days) from intubation to weaning in critically ill (if applicable) and critical patients. Measurement time: During the stay in the COVID-19 internment area, until ventilatory weaning.<br>