None listed
Conditions
Interventions
Drug : Treatment Group:
IP (Ifenprodil) plus Standard of Care (SOC) (N=20)
Control Group:
Standard of Care (SOC) (N=20)
TREATMENT:
Test Product: Ifenprodil, 20 mg TID for up to 4 weeks, in
Sponsors
Dong-A University Hospital
Novotech Asia Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: 1. Male and female patients aged 19-85 years of age, inclusive, as of baseline/screening visit 2. Confirmed coronavirus infection based on possessing at least one of the following etiological evidence: a. Positive real-time fluorescence polymerase chain reaction of the patient’s respiratory or blood specimens for COVID-19 nucleic acid b. Viral gene sequences in respiratory or blood specimens that are highly homologous to COVID-19 c. Any other diagnostic test accepted by local regulatory authorities 3. Presence of severe pneumonia as evidenced by any of the following: a. Respiratory distress with RR >=30 breaths/minute b. SpO2 <90% on room air and at rest c. PaO2/FiO2 =< 250 mmHg (1mmHg = 0.133kPa) 4. Chest imaging (x-ray [XR] or computerized tomography [CT]) confirms severe pneumonia AND shows evidence of inflammatory exudation or pleural effusion 5. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 90 days after the final dose of study drug(s) 6. Non-sterilized males who are sexually active with a female partner of childbearing potential must use condom plus spermicide from day 1 through 90 days after receipt of the last dose of study drug(s) Patients (or their legal designates), must have the capacity to understand, sign and date a voluntary written, informed consent form and any required authorization prior to initiation of any study procedure.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA: 1. Patients with vasodilatory shock, orthostatic hypotension, hypotension, or tachycardia at screening or baseline 2. Patients experiencing cerebral hemorrhage or cerebral infarction at baseline 3. Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 4. Patients taking drugs that increase risk of bleeding (e.g. anti-coagulants, anti-platelet) 5. Patients taking droxidopa 6. ALT/AST > 5 times the upper limit of normal at baseline 7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) at baseline 8. Presence of other disease that may interfere with testing procedures or which in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial 9. Pregnant and lactating women and those planning to get pregnant 10. Known or suspected allergy to the trial drug or the relevant drugs given in the trial 11. Patients who have participated in any other clinical trial/s, including a COVID-19 trial, within the past 3 months 12. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on the rate of change of partial pressure of oxygen (PaO2) and PaO2/FiO2 ratio taken at baseline and measured twice daily up to 4 weeks of treatment in IP versus control group patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the extent of dyspnea from baseline, using a Likert scale, at 24 hours, 72 hours, 7 days and 14 days in IP versus control group Likert scale: The patient grades his current breathing compared to when he first started the drug (from -3 to 3). "0" = no change, "1" =minimally better, "2" =moderately better, "3" =markedly better, "-1" =minimally worse, "-2" =moderately worse, "-3" =markedly worse;Rate of all-cause mortality in IP group versus control group patients;Rate of mechanical ventilation in IP group versus control group patients;Time to hospital discharge for IP group versus control group patients;Type, frequency, severity, and relationship of AEs to investigational product (IP).;Number of patients who discontinue IP due to any AE.;Frequency of clinically significant changes in vital signs and/or laboratory findings.;Rate of change to patient’s experience of cough (Visual analog scale [VAS]) at 24 hours, 72 hours, 7 days and 14 days in IP versus control group VAS: The patient draws a horizontal line on an axial graph (from 0 to 100) to show the degree of how he/she feels about coughing. The number "100" equals the worst coughing the patient has ever felt and the number "0" equals the best he/she has felt since the day of hospital admission.;The area of lung lesions on Chest XR at 7 days and 14 days in IP group versus control group patients;The degree of lung exudation on Chest XR at 7 days and 14 days in IP group versus control group patients;Effect on CRP, cardiac troponin, IL-6, myoglobin and ferritin at 72 hours, 7 days and 14 days between IP group versus control group patients in IP group versus control group patients;Time on mechanical ventilation in IP group versus control group patients | — |
Countries
Korea, Republic of
Contacts
Public ContactDong Sik Jung
Dong-A University Hospital
Outcome results
None listed