VIDA study

Not Applicable

Recruiting

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

• Registration Number: RPCEC00000321
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-22
• Study Completion: 2020-09-15
• Results First Posted: 2020-10-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Virological diagnosis by PCR-RT of infection to SARS-CoV-2.
2) Patients with confirmed respiratory distress / multifocal interstitial pneumonia.
3) Need for oxygen therapy to maintain SO2> 93%.
4) Worsening of lung involvement, defined as one of the following criteria: a) Worsening of oxygen saturation > 3 percentage points or decrease in PaO2 > 10%, with stable FiO2 in the last 24 hours; b) Need to increase FiO2 in order to maintain stable SO2 or new need for mechanical ventilation in the last 24 hours; c) Increase in the number and / or extension of the lung consolidation areas.
5) Patients in whom a clinical condition prior to hyperinflammation is suspected, according to the following criteria: a) sustained fever above 38 combined with criteria 2 or 3 and 4; b) dyspnea requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; c) polypnea greater than 25 ventilations per minute, requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; d) choppy language that does not allow you to count to 10.
6) Express voluntariness of the patient, family member or impartial witness.

Exclusion Criteria

1) Known hypersensitivity to any of the components of the formulation.
2) Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the deterioration of the pulmonary function (Proportion of patients that did not require increasing FiO2 to maintain stable SO2 and without the need for intubation and / or Percentage of patients that decrease the values of positive pressure at the end of expiration [PEEP]). Measurement time: On the 7th day after starting the treatment.