SARS-CoV-2 virus infection MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Domperidona Pensa 10 mg comprimidos EFG
Product Name: FDA277
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
AGENCIA ESTATAL CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS, M.P. (CSIC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient, of either sex, 18 years of age or older. 2. Patient with weight higher than 35 Kg. 3. Patient with a diagnosis of active SARS-CoV-2 infection confirmed by: a. Compatible symptoms (fever, cough, shortness of breath or difficulty breathing, sore throat, body or muscle pain, fatigue, headache, chills, nasal congestion, loss of taste or smell, nausea, vomiting, diarrhea) and a positive result in the detection tests for active infection (PDIA) rapid antigen detection test or in the PCR test for viral RNA detection. b. Patient without symptoms with a positive test result in the detection tests for active infection (PDIA) rapid antigen detection test or in the PCR test for viral RNA detection. 4. Patients presenting with symptoms must present within the last 72 hours with one or more of the following symptoms associated with SARS-CoV-2 infection: fever, cough, dyspnea or shortness of breath, sore throat, body or muscle pain, fatigue, headache. 5. In patients with symptoms due to SARS-CoV-2 infection, the severity of symptoms should be mild or moderate. 6. The patient has received sufficient information about the study orally and in writing and has signed the informed consent to participate in the clinical trial. 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 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Patient living with a patient who has previously been included in the study who continues in follow up (until day 28). 2. Patient who meets any of the following criteria for disease severity: • Need for hospitalization. • Respiratory rate =30 breaths per minute. • More than 100 beats per minute. • Moderate-severe dyspnea (Class II-IV NYHA - resting dyspnea, or withs slight effort or with moderate effort) • Thoracic-pleuritic pain. • Persistent hemoptysis. • Oxygen saturation <94% determined by pulse oximetry. • Systolic blood pressure=90 mmHg or diastolic blood pressure =60 mmHg. • Signs of disseminated intravascular coagulation: hemorrhages (generalized cutaneous-mucosa or small wound); thrombosis (purpura fulminans, peripheral acrocyanosis, gangrene in extremities). • Chest X-ray with bilateral infiltrates, condensations, ground glass opacities. • Need for oxygen therapy. • Symptoms of shock. 3. Patient has any of the following diseases that may be affected or affect the results of the study: • Active infectious disease other than SARS-CoV-2 infection requiring systemic therapy. • Clinically significant uncontrolled respiratory disease. • Prior cardiovascular disease: ischemic heart disease, heart failure, atrial fibrillation. • Severe kidney failure. • Active or treated malignancy. • Immunosuppression due to an illness or the treatment received. • Illness requiring surgical intervention within 30 days following the screening for the study. • Severe obesity. • Other diseases that the physician believes may pose an increased risk to the patient. 4. Contraindications for FDA-277: • Patient with hypersensitivity to FDA-277 or to any of the excipients. • Patients with a prolactin-secreting pituitary tumor (prolactinoma). • Patients in whom stimulation of gastric motility can be dangerous, such as gastrointestinal bleeding, mechanical obstruction or perforation • Patient with moderate to severe liver failure, with results in liver function tests, aspartate transaminase, alanine transaminase, alkaline phosphatase = 5 times the upper limit of normal. • Patient who presents clinically significant abnormalities in the 12-lead electrocardiogram performed during the selection period for the study, specifically existing prolongation of the cardiac conduction intervals, QTc interval. • Patient with underlying heart disease such as congestive heart failure or bradycardia. • Patient with significant electrolyte disturbances such as hypokalaemia, hyperkalaemia, hypomagnesemia. • Patient being treated with drugs that prolong the QT interval. • Patient receiving strong CYP3A4 inhibitor drugs. 5. Pregnant women. 6. Breast-feeding women. 7. A patient with mental impairment that invalidates his/her ability to consent to participate in the study, or that limits his/her ability to comply with the study requirements, or that is expected to be non-cooperative. 8. Patient on treatment with drugs with known antiviral potential. 9. Participation in a clinical trial within the last month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of FDA-277 combined with standard of care on reducing the SARS-CoV-2 viral load.;Primary end point(s): Primary efficacy endpoint • To compare the reduction in viral load (Basal-4 days difference in SARS-CoV-2 copy number) of FDA-277 plus standard of care-treated group versus the standard of care group as an assessment of efficacy at day 4.;Timepoint(s) of evaluation of this end point: Day 4;Secondary Objective: • To evaluate the laboratory efficacy of FDA-277 combined with standard care, in PCR, SARS CoV 2, negative after baseline. • To evaluate the clinical efficacy of FDA-277 combined with standard of care in reducing the proportion of patients presenting with symptoms of COVID-19 disease in the asymptomatic patient group. • To evaluate the clinical efficacy of FDA-277 combined with standard of care in reducing the symptoms of COVID 19 disease. • To evaluate the efficacy of FDA-277 combined with standard of care on the need for medical care, hospitalization, oxygen therapy, or mortality through day 28 from baseline. • To evaluate the safety of FDA-277 administered in patients infected with SARS CoV-2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • To compare the reduction in viral load (Basal-7 days difference, Basal-14 days difference, in SARS-CoV-2 copy number) of FDA-277 plus standard of care-treated group versus placebo plus standard of care as an assessment of efficacy at 7 and 14 days from baseline. • Proportion of patients with negative SARS-CoV-2 PCR result at 4, 7, and 14 days from baseline. • Time from baseline to obtainment of a negative PCR test for SARS-CoV-2. • To evaluate the clinical efficacy of FDA-277 in reducing the symptoms of COVID-19 disease. o The proportion of asymptomatic patients at baseline with one or more symptoms until day 14 and Day 28 or EOS o Reduction in severity of each symptom (0 to 10 point scale) related to SARS-CoV-2 disease at 4, 7, 14, and 28 days or EOS from baseline. o Proportion of patients with clinical improvement, defined as improvement by two or more points on a scale of 0 to 10 points. o Time to clinical improvement. o Proportion of patients in whom each symptom related to SARS-CoV-2 disease disappears at 4, 7, 14, and 28 days from baseline. o Proportion of patients with no symptoms at 4, 7, 14 and 28 days from baseline. o Time to disappearance of each symptom related to SARS-CoV-2 disease from baseline. • To evaluate the efficacy of FDA-277 on the need for medical care, hospitalization, oxygen therapy, or mortality through day 28 from baseline. o Proportion of patients requiring hospitalization, oxygen therapy, or who develop complications from SARS-CoV-2 disease through Day 28 from baseline. o Proportion of patients who die within the 28-day follow-up period and reported mortality within three months of study end. • To evaluate the safety of FDA-277 in patients with COVID-19 disease.;Timepoint(s) of evaluation of this end point: Day 7, Day 14, Day 28 | — |
Countries
Spain
Contacts
Public ContactCoordination of study
E-C-BIO, S.L.
Outcome results
None listed