Name (Synonyms) | Correlation | |
---|---|---|
drug730 | NO-Immunosuppressive Wiki | 0.30 |
drug110 | Azithromycin 250 MG Oral Capsule Wiki | 0.30 |
drug967 | Rintatolimod Wiki | 0.30 |
drug949 | Recombinant Interferon Alfa-2b Wiki | 0.30 |
drug695 | Mesenchymal cells Wiki | 0.30 |
drug258 | Chemotherapy Wiki | 0.30 |
drug1116 | TAK-981 Wiki | 0.30 |
drug147 | Best Practice Wiki | 0.30 |
drug165 | Biospecimen Collection Wiki | 0.30 |
drug1343 | modification of the planned therapeutic management Wiki | 0.30 |
drug568 | Immunoglubulins Wiki | 0.30 |
drug570 | Immunosuppressive Wiki | 0.30 |
drug821 | Pacebo: Calcium citrate Wiki | 0.30 |
drug864 | Placebo oral capsule Wiki | 0.21 |
drug345 | Data Collection Wiki | 0.21 |
drug527 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.17 |
drug506 | Hydroxychloroquine (HCQ) Wiki | 0.17 |
drug752 | Nitazoxanide Wiki | 0.17 |
drug1168 | Tocilizumab Wiki | 0.14 |
drug612 | Ivermectin Wiki | 0.12 |
drug262 | Chloroquine Wiki | 0.11 |
drug1067 | Standard of care Wiki | 0.09 |
drug865 | Placebo oral tablet Wiki | 0.06 |
Name (Synonyms) | Correlation | |
---|---|---|
D009369 | Neoplasms, NIH | 1.00 |
D019337 | Hematologic Neoplasms NIH | 0.40 |
D001943 | Breast Neoplasms NIH | 0.30 |
D010051 | Ovarian Neoplasms NIH | 0.30 |
D014846 | Vulvar Neoplasms NIH | 0.30 |
D002583 | Uterine Cervical Neoplasms NIH | 0.30 |
D009196 | Myeloproliferative Disorders NIH | 0.30 |
D014594 | Uterine Neoplasms NIH | 0.30 |
D014625 | Vaginal Neoplasms NIH | 0.30 |
D007676 | Kidney Failure, Chronic NIH | 0.17 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.17 |
D003324 | Coronary Artery Disease NIH | 0.17 |
D020521 | Stroke NIH | 0.15 |
D008173 | Lung Diseases, Obstructive NIH | 0.13 |
D007239 | Infection NIH | 0.06 |
D003141 | Communicable Diseases NIH | 0.03 |
D011014 | Pneumonia NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001909 | Leukemia HPO | 0.37 |
HP:0100615 | Ovarian neoplasm HPO | 0.30 |
HP:0010784 | Uterine neoplasm HPO | 0.30 |
HP:0100650 | Vaginal neoplasm HPO | 0.30 |
HP:0005547 | Myeloproliferative disorder HPO | 0.30 |
HP:0030416 | Vulvar neoplasm HPO | 0.30 |
HP:0030079 | Cervix cancer HPO | 0.30 |
HP:0003002 | Breast carcinoma HPO | 0.30 |
HP:0001677 | Coronary artery atherosclerosis HPO | 0.17 |
HP:0006510 | Chronic obstructive pulmonary disease HPO | 0.17 |
HP:0001297 | Stroke HPO | 0.15 |
HP:0006536 | Obstructive lung disease HPO | 0.13 |
HP:0002090 | Pneumonia HPO | 0.02 |
There are 11 clinical trials
The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in dose escalation and cancer treatment expansions, and to assess change in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID expansion.
Description: CRS will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants who Experience Cytokine Release Syndrome CRS) Time: Up to 36 monthsDescription: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR) through the study (approximately 3 years), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors and Response Evaluation Criteria in Lymphoma (RECIL) for participants with lymphoma.
Measure: Dose Escalation and Cancer Treatment Expansions: Overall Response Rate (ORR) Time: From the first dose until best response is achieved (up to approximately 3 years)Description: DOR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.
Measure: Dose Escalation and Cancer Treatment Expansions: Duration of Response (DOR) Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to approximately 3 years)Description: DCR is defined as percentage of participants who achieve stable disease (SD) or better greater than (>) 6 weeks during the study in response-evaluable population, as determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.
Measure: Dose Escalation and Cancer Treatment Expansions: Disease Control Rate (DCR) Time: From the first dose until best response is achieved (up to approximately 3 years)Description: PFS will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.
Measure: Dose Escalation and Cancer Treatment Expansions: Progression-free Survival (PFS) Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to approximately 3 years)Description: TTR will be determined by the investigator according to RECIST V1.1 for participants with solid tumors and RECIL for participants with lymphoma.
Measure: Dose Escalation and Cancer Treatment Expansions: Time to Response (TTR) Time: From the date of first study drug administration to the date of first documented PR or better (up to approximately 3 years)Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.
Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs Time: Up to 9 monthsDescription: CRS will be graded as per ASTCT Consensus Grading for CRS.
Measure: COVID-19 Expansion: Number of Participants who Experience CRS Time: Up to 9 monthsDescription: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS) Time: Up to 9 monthsDescription: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).
Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating Time: Up to 9 monthsDescription: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.
Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from the first dose of TAK-981 to viral load negativity (below level of detection).
Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours Time: Up to 9 monthsA novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here we investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.
Description: Incidence rate of SARS-CoV-2 infection within the whole period of the study.
Measure: SARS-CoV-2 infection Time: through study completion, an average of 3 months.Description: Tumor response by determining changes (PD, SD, PR, CR) according to Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1
Measure: Tumor response Time: 6 weeks after enrollment.Description: Safety and tolerability of chemotherapy as measured by the Common Terminology Criteria for Adverse Events (version 4.0)
Measure: Safety and tolerability Time: through study completion, an average of 3 months.Description: Patient-reported outcomes are measured using the EORTC quality of life questionnaire core-30 (QLQ-C30).
Measure: Patient-reported outcomes Time: through study completion, an average of 3 months.The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.
Description: modification of the planned therapeutic management
Measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy) Time: Day OThis is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.
Description: The percentage of HM patients with COVID-19 who died.
Measure: To evaluate mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.
Measure: To evaluate potential predictive biochemical parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.
Measure: To evaluate potential predictive HM-related parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality
Measure: To evaluate COVID severity as predictive parameter of mortality. Time: At 2 months from study initiationDescription: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)
Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity Time: At 6 months from study initiationDescription: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.
Measure: Definition of complete clinical picture of COVID-19 in HM Time: At 2 months from study initiationDescription: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.
Measure: Evolution of HM Time: At 2 months from study initiationDescription: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).
Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics Time: At 2 months from study initiationThis phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
Measure: 7-day length of invasive mechanical ventilation (MV) Time: Up to 7 daysDescription: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: 30-day mortality rate Time: Up to 30-day after randomizationDescription: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of intensive care (ICU) transfer Time: Up to 2 yearsDescription: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of invasive mechanical ventilation Time: Up to 2 yearsDescription: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of tracheostomy Time: Up to 2 yearsDescription: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test
Measure: Length of ICU stay Time: Up to 2 yearsEVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.
Description: The primary endpoint of this study is the recurrence of COVID-19 within 3 months following the immunoassay-positive result obtained before the inclusion in the study. The recurrence is defined by the presence of symptoms confirmed either by a positive reverse transcription‐polymerase chain reaction (RT-PCR) result for SARS-CoV-2 or by the adjudication committee. Immunoassay will be said positive as per the predefined reference corresponding to the immunoassay.
Measure: To evaluate the ability of SARS-CoV-2 immunoassays, following a positive result, to identify patients with very low risk of recurrence of COVID-19 within 3 months. Time: 3 monthsDescription: The prevalence is the ratio between the number of immunoassay-positive patients and the number of patients tested over a predefined period, i.e the whole duration of the study and by 1-month intervals.
Measure: To estimate the prevalence of patients immunized to the SARS-CoV-2 virus in an oncology population over the whole study duration and within one-month periods. Time: 6 monthsDescription: Agreement between the different immunoassays and the centralized ELISA, using the centralized ELISA as benchmark.
Measure: To estimate the discordance rate between local immunoassay and a centralized ELISA in patients with a positive immunoassay, whatever the immunoassay. Time: 6 monthsDescription: COVID-19 recurrence within 6 months following an immunoassay-positive result.
Measure: To identify patients with very low risk of recurrence of COVID-19 within 6 months following a positive immunoassay result. Time: 6 monthsDescription: Quantitative and qualitative detection of SARS-CoV-2-related antibodies and immune serum markers at baseline, 2-3 months and 4-6 months post-inclusion, in a subgroup of 200 patients.
Measure: To characterize the evolution over time of the serologic response against SARS-CoV-2 (in a subgroup of patients). Time: 6 monthsThis phase II trial studies how well tocilizumab works in reducing the serious symptoms of and preventing future complications in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with a response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with the immune system attacking the body. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breath without a breathing machine (ventilator), and prevent patients from having more complications.
This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
Description: This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).
Measure: Incidence of adverse events (AEs) Time: Up to 30 days post treatment intiationDescription: ARDS will be defined by Berlin criteria.
Measure: Reduction of acute respiratory distress syndrome (ARDS) Time: Up to 30 days post treatment initiationDescription: The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.
Measure: 30-day mortality Time: At 30 days post treatment initiationDescription: Will be analyzed using quantitative polymerase chain reaction (PCR).
Measure: Kinetics of viral load in the peripheral blood and nasal swabs Time: During the course of treatment up to day 28Description: The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.
Measure: Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood Time: During the course of treatment up to day 28An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.
Description: Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
Measure: pulmonary embolism (PE) Time: 2 and a half monthsDescription: Incidence of cases reporting at least one fatal or non fatal thrombotic event reported in therapy of MPN
Measure: fatal or non fatal thrombotic event Time: 2 and a half monthsDescription: Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)
Measure: Continuous Positive Airway Pressure (CPAP) Time: 2 and a half monthsDescription: Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation
Measure: invasive ventilation Time: 2 and a half monthsDescription: Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)
Measure: admission in Intensive Care Unit (ICU) Time: 2 and a half monthsDescription: incidence of death
Measure: death Time: 2 and a half monthsDescription: Type of treatments and interventions applied for MPN during COVID-19 and any change reported in therapy of MPN
Measure: treatments and interventions applied for MPN Time: 2 and a half monthsDescription: Type of treatments and interventions applied for COVID-19
Measure: treatments and interventions applied for COVID-19 Time: 2 and a half monthsDescription: Odds Ratios (ORs) of the outcome and 95% Confidence Intervals (CIs) associated with patients' characteristics and treatments
Measure: thrombotic events association to patients characteristic and treatments Time: 2 and a half monthsThis study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
Description: Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.
Measure: Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity Time: Up to 2 yearsDescription: Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for subgroups of patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.
Measure: Effects of COVID-19 on cancer therapy and association with clinical outcomes Time: Up to 2 yearsDescription: Analysis will include time to development of antibodies, prevalence of cytokine abnormalities, and genome-wide association study (GWAS) to define genetic polymorphisms associated with severe COVID-19 disease/mortality.
Measure: Collection of blood specimens for future biomarker studies Time: Up to 2 yearsThe primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5. Time: 5 days of treatmentDescription: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)
Measure: Clinical evolution Time: up to 3 monthsDescription: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock
Measure: Proportion of patients progressing to a severe form Time: up to 3 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples
Measure: Evaluation of viral load drop Time: at day 10Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)
Measure: Tolerance of study treatment Time: up to 3 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: NK immunological study Time: at day 10 and day 30 after treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: Patient follow-up during 3 months : hematological status and associated therapy
Measure: Impact of the study treatment on the treatment of the hematological disease Time: up to 3 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: T immunological study Time: at day 10 and day 30 after treatment