Adult hospitalized patients suffering from COVID-19. MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Atriva Therapeutics GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Study participant must be at least 18 years of age at the time of signing the ICF. 3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection. 4. Body weight at least 50 kg and have a body mass index (BMI) = 18.0 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patient’s clinical condition is worsening rapidly. 2. Requiring ICU admission or ventilator support at screening or at randomization. 3. Suspected bacterial, fungal, viral, or other infection (besides COVID-19). 4. History of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. The medical monitor should be contacted by the investigator. 5. History of hypertension should have hypertension adequately controlled (BP 450 milliseconds. 7. Family history of Long QT Syndrome. 8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA). 9. History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. Patients with implanted defibrillators or permanent pacemakers. 11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %. 12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis. 13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (eGFR, CKD-EPI) 3.0 x ULN. 21. Total bilirubin >1.0 x ULN (=1.5 x ULN total bilirubin if known Gilbert’s syndrome). 22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as “prohibited” in Section 10.5 of the protocol. 23. Taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for COVID-19. Any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and medical monitor. 24. Taking medication that may seriously affect the immune system, e.g. chemotherapy, unless considered and documented as standard of care (e.g. corticosteroids) to treat COVID-19. 25. Currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. Known allergy or hypersensitivity to the IMP (including e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19;Secondary Objective: • To show that ATR-002 in addition to standard of care shortens the time to clinically relevant improvement of COVID-19 for a hierarchically ordered sequence of time-to-event endpoints • To show that the primary endpoint extended as AUC has a more favorable level under ATR-002 compared to placebo in addition to standard of care over the initial trial period of 30 days in adult hospitalized patients with COVID-19 • To explore whether survival time will be prolonged under ATR-002 compared to placebo in addition to standard of care during the initial 30 days of the trial period in adult hospitalized patients with COVID-19;Primary end point(s): • Population: All study participants fulfilling the inclusion and exclusion criteria • Target variable: Clinical severity status on a 7-point ordinal scale at Day 15 • Estimator: Odds ratio of ATR-002 in addition to standard of care versus placebo in addition to standard of care with 95% confidence interval ;Timepoint(s) of evaluation of this end point: • Fulfillment of In-/exclusion criteria on day 1 • Target variable on day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Population defined as above • Target variables: - Time from randomization to discharge from hospital - Time to discharge from hospital or to score of =2 maintained for 24 hours in NEWS2, whichever occurs first - Time to resolution of fever, defined as =36.6°C (axilla), =37.2°C (oral) or =37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours - Time to SpO2 >94% on room air maintained for 24 hours - Clinical severity status over the hospital period calculated as AUC from the 7-point ordinal scale at Days 3, 5, 8, 11, 15 and 30 - Survival time up to Day 30;Timepoint(s) of evaluation of this end point: • Population on day 1 • Target variables: - At any timepoint up to day 30 - Clinical severity status on days 3, 5, 8, 11, 15 and 30 - Survival time up to day 30 | — |
Countries
Argentina, Brazil, Germany, India, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Turkey
Contacts
Public ContactClinical Development Solutions
Atriva Therapeutics GmbH
Outcome results
None listed