Efficacy of E-52862 in the early treatment of confirmed COVID-19 patients
- Conditions
- Patients with mild COVID-19 diseaseTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-003603-33-ES
- Lead Sponsor
- Consorci Mar Parc de Salut de Barcelona
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
1.Adult male and female patients
2.Patients with mild COVID-19 disease: symptomatic patients without evidence of viral pneumonia or hypoxia (WHO criteria)
3.Positive PCR SARS-CoV-2 test
4.Male and female subjects must agree to use acceptable methods of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
Patients who, in the opinion of the clinician, present:
1.Hospital admission criteria
2.Severe dyspnea, and/or fever higher than 38 degrees (ºC) for > 4 days, and/or confirmed pneumonia.
3.Decompensated pulmonary disease or in treatment for current pulmonary disease
4.In the absence of previous pulmonary disease, Oxygen saturation = 95 estimated by using the Roth test (Annex 19.4).
5.In patients with previous pulmonary disease (Oxygen saturation between 90-95%) oxygen saturation = 90% estimated by pulse oximeter
6.Decompensated Diabetes mellitus and / or decompensated HT
7.Patients with the following laboratory values abnormalities:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and
gammaglutamil transpeptidase (GGT) > 2 x ULN (Upper Limit Normality)
• Neutrophils < 1500/mm3
• Lymphocytes < 1000/ mm3
• Haemoglobin < 10 g/dL
• Platelets < 100.000 / mm3
• Prothrombin time: > 1.25 x ULN
• Creatinine clearance according to the Cockroft-Gault equation: < 70 mL/min
• Any other laboratory abnormality that is judged by the investigator to be clinically relevant
8.Active infections like HIV, HCV, HBV, TBC.
9.Patients in treatment with antivirals and/or antiretrovirals.
10.Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study
11.Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator
12.Pregnant women or breastfeeding
13.Any other medical condition that, in the investigator's opinion, could interfere with the validity of the results
14.Patients undergoing current oncologic treatment, including patients with antiemetic treatment with 5-HT3 inhibitors antagonists for nausea and vomiting induced by chemotherapy
15.Major psychiatric disorder or/and history of drug abuse or dependence (drug categories defined by Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) within the past year, excluding nicotine and caffeine
16.Patients in treatment with antipsychotics and/or certain antidepressants (tricyclic antidepressants)
17.Patients receiving any antimalarial treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the evolution of viral load in mild symptomatic patients with confirmed COVID-19.;Secondary Objective: 1. To study the clinical evolution of the confirmed COVID-19 patients.<br>2. Control the adherence to the treatment.<br>3. To identify the safety and tolerability of the drug in these patients.;Primary end point(s): Change in SARS-COV-2 viral load from baseline to day 7;Timepoint(s) of evaluation of this end point: baseline and day 7
- Secondary Outcome Measures
Name Time Method