Covid 19 Research using Clinical Trials (Home Page)
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (19)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1040 | vaccine candidate MVA-MERS-S Wiki | 0.35 |
| drug193 | Chloroquine analog (GNS651) Wiki | 0.35 |
| drug48 | Anakinra and Ruxolitinib (overcome stage 3) Wiki | 0.35 |
| drug505 | Mesenchymal cells Wiki | 0.35 |
| drug219 | Continuous renal replacement therapy Wiki | 0.35 |
| drug47 | Anakinra alone (stages 2b/3) Wiki | 0.35 |
| drug512 | Mindfulness-based "STOP touching your face" practice Wiki | 0.35 |
| drug647 | Prazosin Wiki | 0.35 |
| drug812 | TAK-981 Wiki | 0.35 |
| drug543 | New QIAstat-Dx fully automatic multiple PCR detection platform Wiki | 0.35 |
| drug671 | Questionnaires Wiki | 0.25 |
| drug555 | Nivolumab Wiki | 0.25 |
| drug330 | HB-adMSCs Wiki | 0.25 |
| drug428 | Interferon Beta-1A Wiki | 0.20 |
| drug854 | Tocilizumab Wiki | 0.18 |
| drug478 | Lopinavir/ritonavir Wiki | 0.11 |
| drug691 | Remdesivir Wiki | 0.11 |
| drug360 | Hydroxychloroquine Wiki | 0.09 |
| drug82 | Azithromycin Wiki | 0.08 |
Correlated MeSH Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009362 | Neoplasm Metastasis NIH | 0.35 |
| D019337 | Hematologic Neoplasms NIH | 0.20 |
| D007249 | Inflammation NIH | 0.16 |
| D009369 | Neoplasms, NIH | 0.13 |
| D018352 | Coronavirus Infections NIH | 0.08 |
| D007239 | Infection NIH | 0.06 |
| D013577 | Syndrome NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D014777 | Virus Diseases NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
There are 8 clinical trials
Clinical Trials
1 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019
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.
NCT03648372 Neoplasms Lymphoma Hematologic Neoplasms Coronavirus Disease Drug: TAK-981 Drug: Standard of care MeSH:Coronavirus Infections Hematologic Neoplasms Neoplasms
HPO:Hematological neoplasm Leukemia Neoplasm
Primary Outcomes
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs) Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Dose Limiting Toxicities (DLTs) Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More Serious Adverse Events (SAEs) Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Laboratory Values Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Vital Sign Measurements Time: Up to 36 months
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 months
Measure: COVID-19 Expansion: Number of Participants With >=2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 months
Secondary Outcomes
Measure: Dose Escalation and Cancer Treatment Expansions, Cmax: Maximum Observed Plasma Concentration for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Terminal Disposition Phase Half-life (t1/2z) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Total Clearance After Intravenous Administration (CL) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Description: 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)
Measure: Dose Escalation and Cancer Treatment Expansions: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Post-dose Skin or Tumor Biopsies Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose Skin or Tumor Biopsies at Each Dose Level Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)
Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs Time: Up to 9 months
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 months
Measure: COVID-19 Expansion: Number of Participants Based on Duration of TEAEs Time: Up to 9 months
Description: 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 months
Description: 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 months
Description: 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 months
Description: 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 months
Measure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30 Time: Days 3, 5, 8, 11, 15, and 30
Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria Time: Up to 9 months
Measure: COVID-19 Expansion: Duration of Hospitalization Time: Up to 9 months
Description: 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 months
Description: 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 months
Measure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days Time: Days 30 and 90
2 A Retrospective Study of Evaluating Safety and Efficacy of Tocilizumab Compared to Continuous Renal Replacement Therapy in Controlling CRS Triggered by COVID-19
Primary Outcomes
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs) Time: Up to 36 monthsMeasure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Dose Limiting Toxicities (DLTs) Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More Serious Adverse Events (SAEs) Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Greater Than or Equal to (>=) Grade 3 TEAEs Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Laboratory Values Time: Up to 36 months
Measure: Dose Escalation and Cancer Treatment Expansions: Number of Participants With Clinically Significant Vital Sign Measurements Time: Up to 36 months
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 monthsMeasure: COVID-19 Expansion: Number of Participants With >=2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 months
Secondary Outcomes
Measure: Dose Escalation and Cancer Treatment Expansions, Cmax: Maximum Observed Plasma Concentration for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)Measure: Dose Escalation and Cancer Treatment Expansions, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Terminal Disposition Phase Half-life (t1/2z) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Total Clearance After Intravenous Administration (CL) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981 Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)
Description: 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)Measure: Dose Escalation and Cancer Treatment Expansions: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Post-dose Skin or Tumor Biopsies Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)
Measure: Dose Escalation and Cancer Treatment Expansions: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose Skin or Tumor Biopsies at Each Dose Level Time: Up to Cycle 1 (approximately 3 weeks) (Cycle length =21 days)
Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs Time: Up to 9 months
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 monthsMeasure: COVID-19 Expansion: Number of Participants Based on Duration of TEAEs Time: Up to 9 months
Description: 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 monthsMeasure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30 Time: Days 3, 5, 8, 11, 15, and 30
Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria Time: Up to 9 months
Measure: COVID-19 Expansion: Duration of Hospitalization Time: Up to 9 months
Description: 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 monthsMeasure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days Time: Days 30 and 90
Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.
NCT04306705 Covid-19 SARS Cytokine Storm Cytokine Release Syndrome Tocilizumab Drug: Tocilizumab Other: Standard of care Procedure: Continuous renal replacement therapy MeSH:Syndrome
Primary Outcomes
Description: This is a composite outcome measure. Criteria for fever normalization: Temperature < 36.6 °C armpit, < 37.2 °C oral sustained for at least 72 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) > 94% sustained for at least 72 hours.
Measure: Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14 Time: First dose date up to 14 daysSecondary Outcomes
Description: Measured in days
Measure: Duration of hospitalization Time: Up to 28 daysDescription: Criteria for: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 72 hours.
Measure: Proportion of Participants With Normalization of Fever Through Day 14 Time: First dose date up to 14 daysDescription: Blood routine test
Measure: Change from baseline in white blood cell and differential count Time: Day 1 through Day 28Description: Oropharyngeal or anal swabs
Measure: Time to first negative in 2019 novel Corona virus RT-PCR test Time: Up to 28 daysDescription: Date and cause of death (if applicable).
Measure: All-cause mortality Time: up to 12 weeksDescription: Serum hsCRP
Measure: Change from baseline in hsCRP Time: Day 1 through Day 28Description: Serum inflammatory cytokines
Measure: Change from baseline in cytokines IL-1β, IL-10, sIL-2R, IL-6, IL-8 and TNF-α Time: Day 1 through Day 28Description: Flow cytometry for peripheral whole blood
Measure: Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells Time: Day 1 through Day 28 (if applicable)3 Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults
This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC + Lopinavir/Ritonavir plus interferon ß-1a versus SoC + Hydroxychloroquine. Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
NCT04315948 Corona Virus Infection Drug: Remdesivir Drug: Lopinavir/ritonavir Drug: Interferon Beta-1A Drug: Hydroxychloroquine Other: Standard of care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
Primary Outcomes
Description: 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.
Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale Time: Day 15Secondary Outcomes
Description: Time to an improvement of one category from admission on an ordinal scale. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.
Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale Time: Days 3, 5, 8, 11, 15 and 29Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.
Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Time: Days 3, 5, 8, 11, 15 and 29Measure: Number of oxygenation free days in the first 28 days Time: 29 days
Measure: Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Ventilator free days in the first 28 days Time: 29 days
Measure: Incidence of new mechanical ventilation use during the trial. Time: 29 days
Description: • Duration of hospitalization (days).
Measure: Hospitalization Time: 29 daysDescription: Rate of mortality
Measure: Mortality Time: In hospital, Day 28, Day 90Measure: Cumulative incidence of serious adverse events (SAEs) Time: 29 days
Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: 29 days
Measure: Number of participants with a discontinuation or temporary suspension of study drugs (for any reason) Time: 29 days
Measure: Changes from baseline in blood white cell count Time: 29 days
Measure: Changes from baseline in haemoglobin Time: 29 days
Measure: Changes from baseline in platelets Time: 29 days
Measure: Changes from baseline in creatinine Time: 29 days
Measure: Changes from baseline in blood electrolytes (including kaliemia) Time: 29 days
Measure: Changes from baseline in prothrombine time Time: 29 days
Measure: Changes from baseline in international normalized ratio (INR) Time: 29 days
Measure: Changes from baseline in glucose Time: 29 days
Measure: Changes from baseline in total bilirubin Time: 29 days
Measure: Changes from baseline in alanine aminotransferase (ALT) Time: 29 days
Measure: Changes from baseline in aspartate aminotransferase (AST) Time: 29 days
Other Outcomes
Measure: Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29Measure: Quantitative SARS-CoV-2 virus in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29
Measure: Quantitative SARS-CoV-2 virus in blood Time: Days 3, 5, 8 and 11
Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of lopinavir Time: Days 1, 3, 5, 8 and 11Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of hydroxychloroquine Time: Days 1, 3, 5, 8 and 114 A Prospective, Controlled, Randomized, Multicenter Study to Compare the Efficacy of a Chloroquine Analog (GNS561), an Anti PD-1 (Nivolumab) and an Anti-interleukine-6 Receptor (Tocilizumab) Versus Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of a chloroquine analog (GNS561), an anti PD-1 (nivolumab) and an anti-interleukine-6 receptor (tocilizumab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: - COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-PD1 vs standard of care (randomization ratio 1:1:1). - COHORT 2 (moderate/severe symptoms): GNS561 vs anti-IL6 vs standard of care (randomization ratio 1:1:1).
NCT04333914 SARS-CoV-2 (COVID-19) Infection Advanced or Metastatic Hematological or Solid Tumor Drug: Chloroquine analog (GNS651) Drug: Nivolumab Drug: Tocilizumab Other: Standard of care MeSH:Infection Communicable Diseases Neoplasm Metastasis
Primary Outcomes
Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.
Measure: 28-day survival rate Time: 28 days from randomizationSecondary Outcomes
Description: Time to clinical improvement defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale (WHO-ISARIC) or live discharge from the hospital, whichever comes first.
Measure: Time to clinical improvement Time: 28 days from randomizationDescription: Clinical status will be assessed using a 7-point ordinal scale : 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.
Measure: Clinical status Time: Day 7, Day 14, Day 28Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.
Measure: Mean change in clinical status from baseline to days Time: Day 7, Day 14, Day 28Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Measure: Overall survival Time: 3 months (i.e. at the the time of last patient last visit)Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).
Measure: Length of stay in Intensive Care Unit Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)
Measure: Duration of mechanical ventilation or high flow oxygen devices Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)
Measure: Duration of hospitalization Time: 3 months (i.e. at the the time of last patient last visit)Measure: Rate of throat swab negativation Time: Day 7, Day 14, Day 28
Measure: Quantitative SARS-CoV-2 virus in throat swab and blood samples Time: Day 7, Day 14, Day 28
Measure: Rate of secondary infection by other documented pathogens Time: Day 7, Day 14, Day 28 (if available)
Description: Changes from baseline in neutrophils count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: 3 months (i.e. at the the time of last patient last visit)Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.
Measure: Cost-Effectiveness Analyses (CEA) Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in lymphocytes count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in platelets count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in hemoglobin count (g/dL)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in CRP count (mg/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in pro-inflammatory cytokine (IL6)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)5 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection
This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin
NCT04335552 SARS-CoV-2 Other: Standard of care Drug: Hydroxychloroquine Drug: Azithromycin MeSH:Infection
Primary Outcomes
Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: World Health Organization (WHO) ordinal scale measured at 14 days after enrollment Time: Day 14Secondary Outcomes
Measure: Rates of death during the index hospitalization Time: Index hospitalization, up to 46 daysMeasure: Number of days on mechanical ventilation for patients who were on mechanical ventilation at baseline Time: Baseline
Measure: Proportion of patients not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation during the index hospitalization Time: Index hospitalization, up to 46 days
Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: WHO ordinal scale measured at 28 days after enrollment Time: Day 28Measure: Hospital length of stay in days for the index hospitalization Time: Index hospitalization, up to 46 days
Measure: Rates of all-cause study medication discontinuation Time: Index hospitalization, up to 46 days
Measure: Rates of severe adverse events Time: Day 14
6 Alpha-1 Adrenergic Receptor Antagonism to Prevent COVID-19 Cytokine Storm Syndrome and Acute Respiratory Distress Syndrome: A Randomized Study Comparing the Efficacy of Prazosin vs. Standard of Care for SARS-CoV-2 Infection
The purpose of this study is to assess the efficacy and safety of prazosin to prevent cytokine storm syndrome and severe complications in hospitalized patients with Coronavirus disease 2019 (COVID-19).
NCT04365257 COVID-19 Drug: Prazosin Other: Standard of care
Primary Outcomes
Description: Number of participants in each arm who expire.
Measure: Death Time: up to day 60Description: Number of participants in each arm who are hospitalized and requiring mechanical ventilation and/or high flow nasal cannula and/or ICU/CCU admission (or equivalent) and/or ECMO.
Measure: Hospitalized, requiring mechanical ventilation and/or high flow nasal cannula and/or ICU/CCU admission (or equivalent) and/or ECMO Time: up to day 60Description: Number of participants in each arm who are hospitalized and requiring supplemental oxygen, not requiring ICU/CCU level care (or interventions listed under Outcome 2).
Measure: Hospitalized, requiring supplemental oxygen, not requiring ICU/CCU level care (or interventions listed under Outcome 2) Time: up to day 60Description: Number of participants in each arm who develop grade 3 and 4 adverse events during the study period.
Measure: Cumulative incidence of grade 3 and 4 adverse events Time: up to day 60Description: Number of participants in each arm who develop serious adverse events during the study period.
Measure: Number of participants with serious adverse events Time: up to day 60Description: Number of participants in each arm who develop symptomatic hypotension (systolic blood pressure <90 mmHg) or hypotension requiring cessation of prazosin.
Measure: Incidence of symptomatic hypotension or hypotension requiring cessation of prazosin Time: up to day 60Secondary Outcomes
Description: Number of participants with laboratory abnormalities in peripheral blood (Lymphopenia, leukocytosis, anemia, thrombocytopenia, creatinine, AST/ALT, troponin I, pro-BNP, D-dimer, ferritin, interleukin (IL-6), soluble IL-2 receptor.
Measure: Number of participants with laboratory abnormalities in peripheral blood Time: up to day 60Description: Number of days with laboratory abnormalities in peripheral blood (Lymphopenia, leukocytosis, anemia, thrombocytopenia, creatinine, AST/ALT, troponin I, pro-BNP, D-dimer, ferritin, interleukin (IL-6), soluble IL-2 receptor.
Measure: Duration of laboratory abnormalities in peripheral blood Time: up to day 60Description: Number of participants with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Measure: Number of participants with laboratory abnormalities in plasma Time: up to day 60Description: Number of days with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Measure: Duration of laboratory abnormalities in plasma Time: up to day 607 Interleukin-1 (IL-1) and Interferon Gamma (IFNg) Inhibition During COVID 19 Inflammation: Randomized, Controlled Study Assessing Efficacy and Safety of Anakinra and Ruxolitinib
During SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.
NCT04366232 Covid-19 Drug: Anakinra alone (stages 2b/3) Drug: Anakinra and Ruxolitinib (overcome stage 3) Other: Standard of care MeSH:Inflammation
Primary Outcomes
Description: At least 3 parameters are met including CRP and/or Ferritin among: CRP: decrease > 50% Ferritinemia: decrease > 1/3 Serum creatinine: decrease > 1/3 AST/ALT: decrease > 50% Eosinophils > 50 /mm3 Lymphocytes > 1000 /mm3
Measure: Biological criteria Time: 7 days from enrolmentSecondary Outcomes
Description: Time to become afebrile for a minimum period of 48 hours, without antipyretics
Measure: Time to become afebrile Time: 28 days from enrolmentDescription: Number of days without mechanical ventilation
Measure: Duration of oxygen therapy (days) Time: 28 days from enrolmentDescription: Evolution from clinical stage 2b/3 to overcome stage 3 Admission in Intensive Care Unit
Measure: Number of days without mechanical ventilation Time: 28 days from enrolmentOther Outcomes
Measure: Number of bacterial and/or fungal sepsis Time: 28 days from enrolmentMeasure: Incidence of serious and non-serious adverse events Time: 28 days from enrolment
8 Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19
The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus. In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
NCT04366271 COVID Biological: Mesenchymal cells Drug: Standard of care
Primary Outcomes
Description: Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Measure: Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment Time: 28 daysSecondary Outcomes
Description: Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Measure: Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment Time: 14 daysDescription: Percentage of patients death due to any cause at 28 days of treatment
Measure: Mortality from any cause at 28 days Time: 28 daysDescription: Number of days without mechanical respirator and without vasopressor treatment for 28 days
Measure: Days without mechanical respirator and without vasopressor treatment for 28 days Time: 28 daysDescription: Percentage of patients alive without mechanical ventilation and without vasopressors on day 28
Measure: Patients alive without mechanical ventilation and without vasopressors on day 28 Time: 28 daysDescription: Percentage of patients alive and without mechanical ventilation on day 14
Measure: Patients alive and without mechanical ventilation on day 14 Time: 14 daysDescription: Percentage of patients alive and without mechanical ventilation on day 28
Measure: Patients alive and without mechanical ventilation on day 28 Time: 28 daysDescription: Percentage of patients alive and without vasopressors on day 28
Measure: Patients alive and without vasopressors on day 28 Time: 28 daysDescription: Number of days without vasopressors for 28 days
Measure: Days without vasopressors for 28 days Time: 28 daysDescription: Percentage of patients cured at 15 days
Measure: Patients cured at 15 days Time: 15 daysDescription: Percentage of patients with each adverse event
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 year