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Interim analysis concludes that the study is futile
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A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).
This phase 2/3 study will evaluate the efficacy and safety of ABX464 50mg QD (oral capsule), on treating inflammation and preventing acute respiratory failure in patients infected with SARS-CoV-2.
Eligible patients will be randomized according to a 2:1 ratio into 2 treatment cohorts as follows:
Study design:
The study will consist of 2 periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 | Experimental | ABX464 - Capsules + Standard of Care (SOC) |
|
| Placebo | Placebo Comparator | Placebo - Capsules + Standard of Care (SOC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | ABX464 50mg QD for 28 days + Standard of Care |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | Subjects will be assessed as responders if they did not receive oxygen supplementation through IMV and NIV during the treatment period, and they are alive at the end of the 28-days treatment period. Non responders are subjects who receive oxygen supplementation (through IMV and NIV during the treatment period) and/or who die during the 28-days treatment period. The use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation). Descriptive statistics will be presented by treatment arm. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patients Hospitalized | To evaluate the proportion of patients requiring hospitalization during the study compared to the {Standard of Care + placebo} group An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Efficacy results are only available for the 305 patients randomized at the time of the interim analysis. |
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Inclusion Criteria:
Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR, with at least one associated risk factor. Considered risk factors are:
Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature ≥ 37.8 C oral/tympanic, or ≥ 38.2 C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.
Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric CUA, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier Saint Pierre | Brussels | 1000 | Belgium | |||
| Hôpital Erasme |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABX464 | ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC) |
| FG001 | Placebo | Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2021 | Jan 14, 2022 |
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Phase 2/3, randomized, double blind, placebo-controlled study
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Blinded treatment bottles
| Drug |
Placebo 50mg QD for 28 days + Standard of Care |
|
| 28 days |
| Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale | 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | 28-day treatment period |
| Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | at each study visit during the 28-day treatment period |
| Rate of Patients Requiring Oxygen Supplementation | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | 28-day treatment period |
| Time to Hospitalization | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | 28-day treatment period |
| Time to Assisted Ventilation and Oxygen Supplementation | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | 28-day treatment period |
| Change From Baseline in microRNA-124 Levels | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | at each study visit during the 28-day treatment period |
| Change From Baseline in CRP, Troponin I & T and D-dimer | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | at each study visit during the 28-day treatment period |
| SARS-CoV-2 Viral Load | Nasopharyngeal sample and/or in blood An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | at each study visit during the 28-day treatment period |
| Number and Rates of Participants With Treatment Emergent Adverse Event | Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event | From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period) |
| Brussels |
| 1070 |
| Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa ClÃnica Carlos Borborema | Manaus | Amazonas | 69040-000 | Brazil |
| Centro Oncológico de Roraima - CECOR - NAP | Boa Vista | Roraima | 69310-000 | Brazil |
| Hospital das Clinicas da FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro | Rio de Janeiro | 21040-360 | Brazil |
| Conjunto Hospitalar do Mandaqui | São Paulo | 02401-400 | Brazil |
| Hôpital Nord | Amiens | 80000 | France |
| Centre Hospitalier Départemental de Vendée | La Roche-sur-Yon | 85000 | France |
| Centre Hospitalier Universitaire de Nice | Nice | 06003 | France |
| Hôpital Saint-Antoine | Paris | 75571 | France |
| Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Fondazione IRCCS CÃ Granda - Ospedale Maggiore Policlinico - Infectious Diseases | Milan | Lombardy | 20122 | Italy |
| Ospedale San Paolo | Milan | Lombardy | 20142 | Italy |
| Ospedale Luigi Sacco, AO-PU | Milan | Lombardy | 20157 | Italy |
| Ospedale di Vittorio Veneto - Medecina generale | Vittorio Veneto | Treviso | 31029 | Italy |
| Ospedale A. Manzonidi Lecco - ASST Lecco | Lecco | 23900 | Italy |
| Ospedale Niguarda | Milan | 20162 | Italy |
| Consultorio médico | Mérida | Yucatán | 97070 | Mexico |
| Centro de Prevención y Rehabilitación de Enfermedades Pulmon | Nuevo León | 64460 | Mexico |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| H.G.U. Alicante | Alicante | 03010 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABX464 | ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC) |
| BG001 | Placebo | Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | Subjects will be assessed as responders if they did not receive oxygen supplementation through IMV and NIV during the treatment period, and they are alive at the end of the 28-days treatment period. Non responders are subjects who receive oxygen supplementation (through IMV and NIV during the treatment period) and/or who die during the 28-days treatment period. The use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation). Descriptive statistics will be presented by treatment arm. | An interim analysis was triggered when the first 305 patients were randomized in the study. Randomization was not discontinued during the interim analysis. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Efficacy results are only available for the 305 patients randomized at the time of the interim analysis. | Posted | Count of Participants | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Rate of Patients Hospitalized | To evaluate the proportion of patients requiring hospitalization during the study compared to the {Standard of Care + placebo} group An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Efficacy results are only available for the 305 patients randomized at the time of the interim analysis. | Number of patients randomized at time of Interim analysis | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale | 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | 28-day treatment period |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | at each study visit during the 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Rate of Patients Requiring Oxygen Supplementation | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Hospitalization | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Assisted Ventilation and Oxygen Supplementation | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in microRNA-124 Levels | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | at each study visit during the 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CRP, Troponin I & T and D-dimer | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | at each study visit during the 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | SARS-CoV-2 Viral Load | Nasopharyngeal sample and/or in blood An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | Posted | at each study visit during the 28-day treatment period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number and Rates of Participants With Treatment Emergent Adverse Event | Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event | Analysis of safety was performed on the safety data set consisting in all patients who received at least one dose of ABX464 in the study. A total of 505 patients were included in the Safety Analysis Set. | Posted | Count of Participants | Participants | From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period) |
|
|
49 days
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABX464 | ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC) | 6 | 335 | 36 | 335 | 115 | 335 |
| EG001 | Placebo | Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC) | 4 | 170 | 20 | 170 | 27 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| covid-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Covid-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Severe acute respiratory syndrome | Infections and infestations | Systematic Assessment |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrintestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Oxygen saturation decreased | Investigations | Systematic Assessment |
| ||
| Hepatic artery embolism | Hepatobiliary disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Coronavirus infection | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diiarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Abivax | +33 1 53 83 09 63 | info@abivax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2021 | Jan 14, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623073 | ABX464 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Brazil |
|
| Italy |
|
| Mexico |
|
| United Kingdom |
|
| Germany |
|
| Spain |
|
| France |
|
| Peru |
|
| Missing |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|