Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT04395456
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2020-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721061', 'term': 'AMY-101'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who are alive, without evidence of ARDS (i.e. PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air).', 'timeFrame': '21 days'}, {'measure': 'The proportion of patients assigned to each category, of a six-category ordinal scale.', 'timeFrame': '21 days', 'description': 'The clinical status is based on the following six-category ordinal scale:\n\n* 1: not hospitalised;\n* 2: hospitalised, not requiring supplemental oxygen;\n* 3: hospitalised, requiring supplemental oxygen;\n* 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;\n* 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and\n* 6: death.'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients assigned to each category, of a six-category ordinal scale.', 'timeFrame': 'On days 7, 14, and 44', 'description': 'The clinical status is based on the following six-category ordinal scale:\n\n* 1: not hospitalised;\n* 2: hospitalised, not requiring supplemental oxygen;\n* 3: hospitalised, requiring supplemental oxygen;\n* 4: hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;\n* 5: hospitalised, requiring ECMO, invasive mechanical ventilation, or both; and\n* 6: death.'}, {'measure': 'Proportion of patients surviving', 'timeFrame': 'Through to day 44'}, {'measure': 'Proportion of respiratory failure-free survival', 'timeFrame': 'Day 44', 'description': 'With respiratory failure defined as any of the following:\n\n1. Worsening of severe gas transfer deficit, accounting for a shift in ARDS disease category (PaO2/FiO2 ≤200 for patients with PaO2/FiO2 \\>200 at baseline; PaO2/FiO2 ≤100 for patients with PaO2/FiO2 \\>100 at baseline),\n2. Persistent respiratory distress while receiving oxygen (persistent marked dyspnea,use of accessory respiratory muscles, paradoxical respiratory movements),\n3. Transfer to the intensive care unit for intubation,\n4. Death.'}, {'measure': 'Cumulative incidence of resolution of ARDS (defined as PaO2/FiO2 ≥200 in room air)', 'timeFrame': 'Through day 44'}, {'measure': 'Cumulative incidence of freedom from oxygen requirement', 'timeFrame': 'Through day 44'}, {'measure': 'Proportion of patients requiring invasive mechanical ventilation due to worsening of ARDS', 'timeFrame': 'Within 14 days after inclusion in the study'}, {'measure': 'Proportion of patients requiring non-invasive mechanical ventilation (NIV) due to worsening of ARDS', 'timeFrame': 'Within 14 days after inclusion in the study'}, {'measure': 'Proportion of patients developing thrombotic microangiopathies', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in PaO2 and PaO2/FIO2', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in quick Sequential Organ Failure Assessment Score (qSOFA: respiratory rate, systolic blood pressure, Glasgow Coma Scale (GCS)', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in maximal and minimal cardiovascular parameters: Respiratory rate', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in maximal and minimal cardiovascular parameters: Heart Rate', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in levels of biomarkers of inflammation (CBC, CRP, Ferritin, Procalcitonin, D-dimers, LDH)', 'timeFrame': 'On days 0, 1, 2, 4, 7, 10, 14, 21 and 44'}, {'measure': 'Length of stay in ICU', 'timeFrame': 'Through day 44'}, {'measure': 'Cumulative incidence of discharge from hospital', 'timeFrame': 'Through day 44'}, {'measure': 'Number of adverse events', 'timeFrame': 'Through day 44'}, {'measure': 'Changes in levels of anti-drug antibodies', 'timeFrame': 'On day 0 , 14 and 44'}, {'measure': 'Changes in levels of biomarkers of complement activity: C3, C3a, C5a, sC5b-9', 'timeFrame': 'On days 0, 1, 2, 4, 7, 10, 14, 21 and 44'}, {'measure': 'Changes in levels of biomarkers of cytokine release syndrome: IL-1, IL-6, IL-12', 'timeFrame': 'On days 0, 1, 2, 4, 7, 10, 14, 21 and 44'}, {'measure': 'Changes in levels of Club Cell protein CC16 (biomarker of lung damage )', 'timeFrame': 'On days 0, 1, 2, 4, 7, 10, 14, 21 and 44'}, {'measure': 'Changes in levels of AMY-101 plasma level', 'timeFrame': 'On days 1, 2, 4, 7, 10, 14, 15, 21'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome Due to SARS-CoV-2 Infection (Severe COVID19)']}, 'referencesModule': {'references': [{'pmid': '32327719', 'type': 'BACKGROUND', 'citation': 'Risitano AM, Mastellos DC, Huber-Lang M, Yancopoulou D, Garlanda C, Ciceri F, Lambris JD. Complement as a target in COVID-19? Nat Rev Immunol. 2020 Jun;20(6):343-344. doi: 10.1038/s41577-020-0320-7. Epub 2020 Apr 23.'}, {'pmid': '32360516', 'type': 'BACKGROUND', 'citation': 'Mastaglio S, Ruggeri A, Risitano AM, Angelillo P, Yancopoulou D, Mastellos DC, Huber-Lang M, Piemontese S, Assanelli A, Garlanda C, Lambris JD, Ciceri F. The first case of COVID-19 treated with the complement C3 inhibitor AMY-101. Clin Immunol. 2020 Jun;215:108450. doi: 10.1016/j.clim.2020.108450. Epub 2020 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of patients with ARDS caused by SARS-CoV-2 infection.\n\nWe will assess the efficacy and safety, as well as pharmacokinetics (PK), and pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe Covid-19), according to the following criteria:\n\n 1. Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL)\n 2. A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, ≤300 mmHg\n\n * Mild ARDS (PaO2/FIO2, ≤300 and \\>200 mm Hg);\n * Moderate ARDS (PaO2/FIO2, ≤200 and \\>100 mm Hg);\n * Severe ARDS (PaO2/FIO2, ≤100 mm Hg);\n 3. Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan.\n* Dated and signed informed consent from patient or legal represantative.\n\nExclusion Criteria:\n\n* Intubated patients\n* Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 µg/L)\n* Demonstrated local extrapulmonary abscess\n* ARDS due to cardiac failure or fluid overload\n* Concomitant treatment with immunomodulatory /immunosuppressive drugs , which have potential activity against the disease\n* Multi Organ Failure (MOF)\n* Severe renal failure (CKD, by defition glomerular filtration rate \\<30 ml/min)\n* Neisseria meningitidis infection that is not resolved\n* Current treatment with a complement inhibitor\n* Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening\n* Participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater.\n* Chemotherapy for less than 3months\n* Pregnancy\n* Age \\<18.'}, 'identificationModule': {'nctId': 'NCT04395456', 'acronym': 'SAVE', 'briefTitle': 'A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amyndas Pharmaceuticals S.A.'}, 'officialTitle': 'A Phase 2 Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor, AMY-101, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 (SAVE)', 'orgStudyIdInfo': {'id': 'AMY-101_SAVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMY-101', 'interventionNames': ['Drug: AMY-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: WFI 5% glucose']}], 'interventions': [{'name': 'AMY-101', 'type': 'DRUG', 'description': 'C3 complement inhibitor', 'armGroupLabels': ['AMY-101']}, {'name': 'WFI 5% glucose', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amyndas Pharmaceuticals S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}