ESPERANZA study

Phase 2

Recruiting

• Conditions: SARS Virus; patients infected with the SARS-CoV-2 coronavirus.; covid-19; Coronavirus Infections; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000307
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-14
• Study Completion: 2020-08-15
• Results First Posted: 2020-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1) Positivity to SARS-CoV-2 by rapid or confirmatory test of qPCR.
2) ECOG functional status = 2 (Karnofsky = 70%).
3) Voluntariness of the patient by signing the informed consent.

Exclusion Criteria

1) Patients with decompensated chronic diseases at the time of inclusion (severe arterial hypertension, ischemic heart disease, diabetes mellitus, etc.).
2) Patients with a history of autoimmune diseases.
3) Presence of hyperinflammation syndrome.
4) Serious coagulation disorders.
5) Known hypersensitivity to any of the components of the formulation under study.
6) Pregnancy or lactation.
7) Obvious mental incapacity to issue consent and act accordingly with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Virological evaluation: Time until the negativity of the SARS-Cov-2 RNA (absence of the virus according to the qPCR technique in real time) in positive patients after starting antiviral therapy (the percentage of patients negative for SARS will be calculated). VOC-2 by qPCR in tissue of nasopharyngeal exudate Measurement time: 48, 72 and 96 hours after starting treatment.<br>2) Clinical evaluation: Time to progression to severe COVID-19 (the percentage of patients who become severe will be calculated). Measurement time: 3rd week, after completion of the antiviral treatment under investigation.