Patients with mild COVID-19 disease
Conditions
Interventions
Product Name: E-52862
Product Code: MR309
Pharmaceutical Form: Capsule
INN or Proposed INN: None registered
CAS Number: 1265917-14-3
Current Sponsor code: E-52862
Other descriptive name: MR309
Concent
Sponsors
Consorci Mar Parc de Salut de Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Control the adherence to the treatment. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in SARS-COV-2 viral load from baseline to days 4 and 14 2. Incidence of patients with negative PCR test at days 4, 7 and 14 3. Time to negative PCR test 4. Viral load at days 4, 7 and 14 5. AUC for viral load, time-weighted for patient study duration 6. Proportion of patients that are recovered during the study and time to clinical recovery (duration and severity of symptoms) 7. Proportion of deceased patients 8. Incidence of hospital admissions, incidence of ICU admissions, incidence of mechanical ventilation. 9. Time-to hospitalization. 10. Length of hospital stay. 11. Complications during hospitalization: - Hypoxia - Low flow oxygen need - High flow oxygen need - Hypoxemic respiratory failure - Hypercapnic respiratory failure - Orotracheal intubation - Acute kidney failure - Need for vasoactive drugs - Need for treatment with steroids or biological drugs (e.g., anti-IL-5, anti-IL6, anti-IL-1) 12. Incidence of consultations to hospital emergencies 13. Symptoms during telephone monitoring 14. Concomitant Medications: Incidence and total use during the study 15. Adverse events stratified for severity using CTCAE 16. Clinical laboratory parameters, vital signs and ECG in visits;Timepoint(s) of evaluation of this end point: Every two days, investigator will contact patients by phone for the next 21 days to register the evolution of symptoms. On days 4, 7, 14 and 21, patients should have a face to face visit to assess the clinical evolution of symptoms (including daily record of fever), and to perform the laboratory tests. An oropharyngeal swab RT-PCR test will be performed on days 4, 7 and 14. In the 21-day follow-up visit a standard haematology, coagulation and biochemistry, vital signs assessment and an ECG will be performed. A total of 5 clinical visits will be carried out: pre-treatment, +4, +7 and +14 treatment days, and follow-up (day 21). | — |
Countries
Spain
Contacts
Public ContactJordi Monfort Faure
Hospital del Mar
Outcome results
None listed