CIGB-258 at COVID-19

Not Applicable

Completed

• Conditions: COVID-19 respiratory distress; COVID-19; SARS-CoV-2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; Severe Acute Respiratory Syndrome

• Registration Number: RPCEC00000313
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-14
• Study Completion: 2020-05-30
• Results First Posted: 2020-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

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) Express voluntariness of the patient, family member or impartial witness.

Exclusion Criteria

- Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality on discharge from the ICU (Proportion of patients who die, according to their causes). Measurement time: during the stay in the Intensive Care Unit.