COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000344-21/RO

MetrioPharm Deutschland GmbH - Clinical Department

clinicaltrials@metriopharm.com

2022-04-21

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 least 30 days after the last dose of study medication: a) 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) b) Use of 1 of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant, intrauterine device or intrauterine system, oral contraceptive, either combined or progestogen alone, injectable progestogen, contraceptive vaginal ring, percutaneous contraceptive patches. c) Vasectomy of male partner with documentation of azoospermia.

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 <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors, respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >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 has any condition, in the opinion of the investigator, that will not allow the protocol to be followed safely.

2

MetrioPharm AG

18

100

Belgium;Bulgaria;Czech Republic;France;Hungary;Italy;Mexico;Poland;Romania;Spain;United States;Switzerland

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

17

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.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

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