Moderate to severe coronavirus disease 2019 (COVID 19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862 MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862 MedDRA version: 23.1 Level: LLT Class
Conditions
Sponsors
MetrioPharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol or, for adults incapable of consenting due to their medical condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory authorities, institutional review boards (IRBs)/independent ethics committees (IECs), or local laws; 2. The patient is male or female adult aged =18 years (as per local laws) at the time of giving informed consent; 3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Please note: If the patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required; 4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1, such as presence of fever (=38.0°C [=100.4°F] by any route), loss of smell or taste, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath upon exertion and/or at rest, or respiratory distress; 5. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1: a) Moderate: i. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, SpO2 >93% (on room air at sea level, if possible), heart rate =90 beats per minute ii. No clinical signs indicative of severe or critical COVID-19 b) Severe: i. Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate =30 breaths per minute, heart rate =125 beats per minute, SpO2 =93% (on room air at sea level, if possible), partial pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory distress syndrome (according to the Berlin definition) ii. No criteria met for critical COVID-19 6. The patient does not require hemodialysis (chronic) or any renal replacement therapies at screening or Day 1; 7. The patient is able to swallow the study drug (hard gelatin capsules); 8. The patient agrees to minimize strong sun exposure (sunbathing) and strong ultraviolet exposure during the course of the study. Additionally, during the study, patients must agree to use sunscreen when spending an extended period outdoors; 9. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication: a) Vasectomy with documentation of azoospermia. b) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication) c) Male condom plus partner use of 1 of the contraceptive options below: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. 10. WOCBP must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at l
Exclusion criteria
Exclusion criteria: 1. The patient, in the opinion of the investigator, is not likely to survive for =48 hours beyond Day 1. 2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1. a) Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms. b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness but no clinical signs indicative of moderate, severe, or critical COVID-19. c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least 1 of the following: shock defined by systolic blood pressure 20 L/min with fraction of delivered oxygen =0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation), and/or multi-organ dysfunction/failure. 3. The patient has a Child Pugh score = C. 4. The patient has a documented medical history of infection with hepatitis A, B, or C at screening or Day 1. 5. The patient has a documented medical history of infection with human immunodeficiency virus and has a detectable viral load and CD4 count <500 cells/µL. 6. The patient has a documented active infection with tuberculosis at screening or Day 1. 7. The patient has clinically significant electrocardiogram abnormalities at screening. 8. A female patient who is pregnant, planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and before dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests. 9. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug. 10. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study. 11. The patient has a history of sensitivity to any of the study medications, components thereof (eg, mannitol or gelatin), or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation. 12. The patient has participated in and/or plans to participate in another clinical study using an investigational product within the following period before the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). 13. The patient will be transferred to another hospital that is not a study site within 72 hours. Please note: If the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization. 14. The patient is employed by MetrioPharm, the contract research organization or clinical site involved in the clinical study. 15. The investigator makes a decision that study involvement is not in patient’s best interest, or the patient h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19);Timepoint(s) of evaluation of this end point: Day 14;Secondary Objective: The secondary objectives of this study are: • To measure the effect of MP1032 plus SoC versus placebo plus SoC on Day 28 on disease progression in patients with moderate to severe COVID-19; • To measure the effect of MP1032 plus SoC versus placebo plus SoC on disease resolution on Day 14 and Day 28; • To measure the effect of MP1032 plus SoC versus placebo plus SoC on the mortality rate and other specific COVID-19 related characteristics; • To assess the safety of MP1032 (eg, adverse events [AEs] and laboratory abnormalities); • To assess the pharmacokinetics (PK) of MP1032 on Day 1 (single dose) and Day 7 (steady state) in a PK subset of patients. The exploratory objectives of this study are: • To measure the effect of MP1032 plus SoC versus placebo plus SoC on some additional COVID-19 related characteristics; • To evaluate the health-related quality of life (HRQoL) of patients treated MP1032 plus SoC compared with placebo plus SoC; • To evaluate biomarker levels.;Primary end point(s): The primary efficacy endpoint of this study is the proportion of patients with disease progression on Day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoints of this study are: • Proportion of patients with disease progression on Day 28. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the NIAID 8-point ordinal scale. • Proportion of patients with disease resolution on Day 28. Disease resolution is defined as patients who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. • All-cause mortality rate at Day 28 • Change of clinical status related to COVID-19 on Day 28 compared with baseline according to the following NIAID 8-point ordinal scale: 1. Death; 2. Hospitalized, on invasive ventilation (mechanical ventilator and/or extracorporeal membrane oxygenation [ECMO]); 3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons); 7. Not hospitalized, limitation on activities, and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities. The other secondary endpoints of this study are: • Proportion of patients with disease resolution on Day 14. Disease resolution is defined as patients who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. • All-cause mortality rate at Day 14 and Day 60 • Change of clinical status related to COVID-19 on Day 14 compared with baseline according to the NIAID 8-point ordinal scale as listed above. • Proportion of patients requiring invasive ventilation (mechanical ventilator and/or ECMO), or who are not alive on Day 14 or Day 28 • Proportion of patients in each category of the NIAID 8-po | — |
Countries
Belgium, Bulgaria, Czechia, France, Hungary, Italy, Mexico, Poland, Romania, Spain, United States
Contacts
Public ContactClinical Department
MetrioPharm Deutschland GmbH
Outcome results
None listed