Covid 19 Research using Clinical Trials (Home Page)
Standard careWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2135 | SARS-CoV-2 convalescent plasma treatment Wiki | 0.38 |
| drug1123 | Hydroxychloroquine plus Nitazoxanide Wiki | 0.38 |
| drug1249 | Intravenous Immunoglobulin Wiki | 0.38 |
| drug2423 | TD139 Wiki | 0.38 |
| drug255 | Awake Prone Positioning Wiki | 0.38 |
| drug2440 | Taking biological samples Wiki | 0.38 |
| drug659 | Convalescent plasma (CP) Wiki | 0.38 |
| drug2891 | methylprednisolone therapy Wiki | 0.38 |
| drug554 | Chest MRI Wiki | 0.38 |
| drug1566 | Nafamostat Mesilate Wiki | 0.27 |
| drug2457 | Telemedicine Wiki | 0.22 |
| drug1372 | Lopinavir/ritonavir Wiki | 0.12 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011665 | Pulmonary Valve Insufficiency NIH | 0.15 |
| D008180 | Lupus Erythematosus, Systemic NIH | 0.15 |
| D008171 | Lung Diseases, NIH | 0.10 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D011014 | Pneumonia NIH | 0.04 |
| D007239 | Infection NIH | 0.04 |
| D013577 | Syndrome NIH | 0.04 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
| D003141 | Communicable Diseases NIH | 0.03 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002725 | Systemic lupus erythematosus HPO | 0.15 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.15 |
| HP:0002088 | Abnormal lung morphology HPO | 0.10 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 7 clinical trials
Clinical Trials
1 Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.
NCT04244591 COVID-19 Infections Drug: methylprednisolone therapy Other: Standard care MeSH:Infection
Primary Outcomes
Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomizationSecondary Outcomes
Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 7 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 7 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 7 days after randomizationDescription: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 14 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 14 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 14 days after randomizationDescription: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
Measure: Clearance of noval coronavirus Time: 14 days after randomizationDescription: All-cause mortality
Measure: All-cause mortality Time: 30 days after randomization2 A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
NCT04261426 2019-nCoV Drug: Intravenous Immunoglobulin Other: Standard care MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Clinical improvement based on the 7-point scale Time: 28 days after randomization
Description: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomization
Description: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomization
Secondary Outcomes
Description: Number of deaths during study follow-up
Measure: 28-day mortality Time: Measured from Day 0 through Day 28
Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measure: Duration of mechanical ventilation Time: Measured from Day 0 through Day 28
Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measure: Duration of hospitalization Time: Measured from Day 0 through Day 28
Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Measure: Proportion of patients with negative RT-PCR results Time: 7 and 14 days after randomization
Description: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Proportion of patients in each category of the 7-point scale Time: 7,14 and 28 days after randomization
Description: Proportion of patients with different inflammation factors in normalization range.
Measure: Proportion of patients with normalized inflammation factors Time: 7 and 14 days after randomization
Description: Frequency of Adverse Drug Events
Measure: Frequency of Adverse Drug Events Time: Measured from Day 0 through Day 28
Description: Frequency of Serious Adverse Drug Events
Measure: Frequency of Serious Adverse Drug Events Time: Measured from Day 0 through Day 28
3 Clinical Trial Evaluating Safety and Efficacy of Hydroxychloroquine and Nitazoxanide Combination as Adjuvant Therapy in Covid-19 Newly Diagnosed Egyptian Patients: A Tanta University Hope
Primary Outcomes
Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Clinical improvement based on the 7-point scale Time: 28 days after randomizationDescription: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomizationSecondary Outcomes
Description: Number of deaths during study follow-up
Measure: 28-day mortality Time: Measured from Day 0 through Day 28Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measure: Duration of mechanical ventilation Time: Measured from Day 0 through Day 28Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measure: Duration of hospitalization Time: Measured from Day 0 through Day 28Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Measure: Proportion of patients with negative RT-PCR results Time: 7 and 14 days after randomizationDescription: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Proportion of patients in each category of the 7-point scale Time: 7,14 and 28 days after randomizationDescription: Proportion of patients with different inflammation factors in normalization range.
Measure: Proportion of patients with normalized inflammation factors Time: 7 and 14 days after randomizationDescription: Frequency of Adverse Drug Events
Measure: Frequency of Adverse Drug Events Time: Measured from Day 0 through Day 28Description: Frequency of Serious Adverse Drug Events
Measure: Frequency of Serious Adverse Drug Events Time: Measured from Day 0 through Day 28In December 2019, a new infectious respiratory disease emerged in Wuhan, Hubei province, China. An initial cluster of infections was linked to Huanan seafood market, potentially due to animal contact. Subsequently, human-to-human transmission occurred and the disease, now termed coronavirus disease 19 (COVID-19) rapidly spread within China and all over the world. A novel coronavirus, SARS-coronavirus 2 (SARS-CoV-2), which is closely related to SARS-CoV, was detected in patients and is believed to be the etiologic agent of the new lung disease. The causative agent of the current COVID-19 pandemic, SARS-CoV-2, is a single stranded positive sense RNA virus that is closely related to severe acute respiratory syndrome coronavirus (SARS-CoV).
NCT04361318 COVID-19 Combination Product: Hydroxychloroquine plus Nitazoxanide Other: Standard care
Primary Outcomes
Description: PCR analysis of COVID-19 RNA in patients
Measure: Number of patients with COVID-19-negative PCR Time: within 10 days to become PCR negativeSecondary Outcomes
Description: improved breaths per minute for the patients
Measure: Number of patients with improved respiratory rate Time: within 30 daysDescription: Change in PaO2 in mmHg of the patients
Measure: Number of patients with improved PaO2 Time: within 30 daysDescription: Serum IL6 in pg/mL of the patients
Measure: Number of patients with normalized Serum IL6 Time: within 30 daysDescription: Serum TNFα in pg/mL of the patients
Measure: Number of patients with normalized Serum TNFα Time: within 30 daysDescription: Serum iron in microgram/dL of the patients
Measure: Number of patients with normalized Serum iron Time: within 30 daysDescription: Serum ferritinin microgram/L of the patients
Measure: Number of patients with normalized Serum ferritin Time: within 30 daysDescription: International normalized ratio "INR" for prothrombin time of 2
Measure: Number of patients with normalized International normalized ratio "INR" for prothrombin time Time: within 30 daysDescription: CBC for lymphocyte count in cells/microliter
Measure: Number of patients with normalized complete blood count "CBC" Time: within 30 daysDescription: Mortality rate [number of dead patients/total number of treated patients]
Measure: The Mortality rate among treated patients Time: within 30 days4 Use of Telemedicine for Follow-up of Systemic Lupus Erythematosus ("TeleSLE") in the COVID-19 Outbreak: a Pragmatic Randomised Controlled Trial
Background Patients with systemic lupus erythematosus (SLE) might be more susceptible to Covid-19 due to the underlying disease, co-morbidities and the use of immunosuppressive drugs. The investigators hypothesize that telemedicine (TM) can be an effective mode of health-care delivery minimizing the risk of SARS-CoV-2 exposure, while maintaining disease control in these patients. Objectives The primary aim of this study is to evaluate the effectiveness to achieve remission or lupus low disease activity state (LLDAS) using TM delivered care compared to conventional in-person outpatient follow-up in SLE. The secondary objectives are to compare the patient reported outcomes and cost between the two modes of health care delivery. Study design This is a 12-months single centered pragmatic randomized controlled study. A total of 150 enrolled patients with SLE being followed at the Prince of Wales Hospital rheumatology clinics will be randomized to either TM (TM group) or standard care (SC group) in a 1:1 ratio. Patients in the TM group will receive scheduled follow-ups via videoconferencing using a custom-made mobile app. SC group patients will continue conventional standard in-person outpatient care. The disease and patient reported outcomes as well as the health care related costs will be compared. Expected outcomes Data from this study will support the notion that TM based care is as effective as conventional in-person care in achieving disease remission or LLDAS, as well as addressing psychosocial implications to ensure the best possible care for our patients in a cost-effective manner during this pandemic.
NCT04368299 SLE Other: Telemedicine Other: Standard care MeSH:Lupus Erythematosus, Systemic
HPO:Systemic lupus erythematosus
Primary Outcomes
Measure: The percentage of patients in remission or LLDAS at one year. Time: 1 year
Secondary Outcomes
Measure: Direct and indirect costs after one year. Time: 1 year
Description: LupusQoL evaluates 8 domains including physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Questionnaire has a 5-point Likert response format (0=all the time, 1=most of the time, 2=a good bit of the time, 3=occasionally, and 4=never). Higher score means better quality of life.
Measure: The change of Lupus Quality of Life (LupusQoL) at one year. Time: 1 year
Description: They are in a 5-point Likert response format (0=strongly disagree, 1=disagree, 2=neutral, 3=agree, and 4=strongly agree). Higher score means more confident and satisfied.
Measure: Patient confidence and satisfaction score at one year. Time: 1 year
Measure: Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year. Time: 1 year
Measure: Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year. Time: 1 year
Description: HAQ-DI covers various common daily activities to assess disability.It consists of 8 questions. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). Higher score means higher disability.
Measure: The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year. Time: 1 year
Description: HADS was developed to assess anxiety and depression in medical patients. Each domain has 7 items. Each item are answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher score means more likely the patient has anxiety or depression.
Measure: The change of (Hospital Anxiety and Depression Scale) HADS at one year. Time: 1 year
5 Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
Primary Outcomes
Measure: The percentage of patients in remission or LLDAS at one year. Time: 1 yearSecondary Outcomes
Measure: Direct and indirect costs after one year. Time: 1 yearDescription: LupusQoL evaluates 8 domains including physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Questionnaire has a 5-point Likert response format (0=all the time, 1=most of the time, 2=a good bit of the time, 3=occasionally, and 4=never). Higher score means better quality of life.
Measure: The change of Lupus Quality of Life (LupusQoL) at one year. Time: 1 yearDescription: They are in a 5-point Likert response format (0=strongly disagree, 1=disagree, 2=neutral, 3=agree, and 4=strongly agree). Higher score means more confident and satisfied.
Measure: Patient confidence and satisfaction score at one year. Time: 1 yearMeasure: Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year. Time: 1 year
Measure: Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year. Time: 1 year
Description: HAQ-DI covers various common daily activities to assess disability.It consists of 8 questions. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). Higher score means higher disability.
Measure: The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year. Time: 1 yearDescription: HADS was developed to assess anxiety and depression in medical patients. Each domain has 7 items. Each item are answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher score means more likely the patient has anxiety or depression.
Measure: The change of (Hospital Anxiety and Depression Scale) HADS at one year. Time: 1 yearProne positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
NCT04395144 Coronavi Coronavirus Infection COVID Severe Acute Respiratory Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Distress Syndrome ARDS Lung Diseases Procedure: Awake Prone Positioning Procedure: Standard care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Pulmonary Valve Insufficiency Syndrome
HPO:Abnormal lung morphology Pulmonary insufficiency
Primary Outcomes
Measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death Time: Up to 28 days after randomization
Secondary Outcomes
Measure: Intubation rate Time: Up to 28 days after randomization
Measure: Mortality Time: Up to 28 days after randomization
Measure: Days spent on mechanical ventilation Time: Until discharge, up to 24 weeks after randomization
Measure: Days spent in the ICU Time: Until discharge, up to 24 weeks after randomization
Measure: Hospital stay (in days) Time: From admission to discharge, up to 24 weeks after randomization
Other Outcomes
Description: Total time spent in prone position, as recorded by nursing or respiratory therapists
Measure: Time in prone position Time: Up to 28 days post randomization
Description: Daily evolution of oxygenation
Measure: Oxygenation (SpO2/FiO2 ratio) Time: Until HFNC weaning, or up to 14 days after randomization, whichever is first
6 Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
Primary Outcomes
Measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death Time: Up to 28 days after randomizationSecondary Outcomes
Measure: Intubation rate Time: Up to 28 days after randomizationMeasure: Mortality Time: Up to 28 days after randomization
Measure: Days spent on mechanical ventilation Time: Until discharge, up to 24 weeks after randomization
Measure: Days spent in the ICU Time: Until discharge, up to 24 weeks after randomization
Measure: Hospital stay (in days) Time: From admission to discharge, up to 24 weeks after randomization
Other Outcomes
Description: Total time spent in prone position, as recorded by nursing or respiratory therapists
Measure: Time in prone position Time: Up to 28 days post randomizationDescription: Daily evolution of oxygenation
Measure: Oxygenation (SpO2/FiO2 ratio) Time: Until HFNC weaning, or up to 14 days after randomization, whichever is firstThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
NCT04425837 Sars-CoV2 Covid-19 Biological: SARS-CoV-2 convalescent plasma treatment Other: Standard care
Primary Outcomes
Description: Death of the patient (yes/no)
Measure: Mortality Time: Up to 30 days after the study enrollmentDescription: Presence of any of the following adverse events (yes/no): Nonhemolytic febrile reactions Allergic reactions Acute hemolytic reactions Non-immune hemolysis Acute transfusion-related lung damage Transfusion-related circulatory overload Metabolic reactions Hypotensive reactions Delayed hemolytic reactions Post transfusion purple Graft versus host disease Bacterial contamination of blood components Viral infections Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
Measure: Adverse events Time: Up to 30 days after the study enrollmentDescription: Admitted to intensive care units (ICUs) (yes/no)
Measure: ICU admission Time: Up to 30 days after the study enrollmentDescription: Mechanical ventilation requirement (yes/no)
Measure: Mechanical ventilation Time: Up to 30 days after the study enrollmentSecondary Outcomes
Description: Intensive care unit length of stay
Measure: ICU length Time: Up to 30 days after the study enrollmentDescription: D dimer reduction below 1mcg / ml
Measure: Reduction of D Dimer Time: Assessment at day 30 after study enrollmentDescription: Reduction of LDH below 350 IU / L
Measure: LDH reduction Time: Assessment at day 30 after study enrollmentDescription: Reduction of troponin level to than 8 pg / mL
Measure: Reduction of Troponin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in ferritin level below 1025 mcg / L
Measure: Decrease in ferritin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in procalcitonin level below 0.1ng / ml
Measure: Decrease in procalcitonin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in CRP level bellow <8 mg / L
Measure: Decrease in CRP Time: Assessment at day 30 after study enrollmentDescription: Increase in lymphocyte count greater than 0.6 x 10-9 / L
Measure: Increase in lymphocyte count Time: Assessment at day 30 after study enrollmentDescription: Increase in PaO2 / Fio2 greater than 200
Measure: Increase in PaO2 / Fio2 Time: Assessment at day 30 after study enrollmentDescription: Scale of 24 points, greater number indicates worst outcome
Measure: Decrease in Sequential Organ failure assessment (SOFA ) score Time: Assessment at day 30 after study enrollmentDescription: Extracorporeal membrane oxygenation requirement (ECMO)
Measure: Extracorporeal membrane oxygenation (ECMO) Time: Assessment at day 30 after study enrollmentDescription: Decrease in the percentage of lung infiltration
Measure: Lung infiltration Time: Assessment at day 30 after study enrollment7 Rapid Experimental Medicine for COVID-19 - DEFINE COVID-19
COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus, SARS CoV2 and is a serious condition with high mortality in hospitalised patients, for which there is no currently approved treatment other than supportive care. Urgent investigation of potential treatments for this condition is required. This protocol describes an overarching and adaptive trial designed to provide safety, pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biological surrogates of efficacy which may support further development and deployment of candidate therapies in larger scale trials of COVID-19 positive patients receiving normal standard of care. Given the spectrum of clinical disease, community based infected patients or hospitalised patients can be included. Products requiring parenteral administration will only be investigated in hospitalised patients. Patients will be divided into cohorts, a) community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computed tomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiring assisted ventilation. Participants may be recruited from all three of these cohorts, depending on the experimental therapy, its route of administration and mechanism of action. The relevant cohort(s) for any given therapy will be detailed in the therapy-specific appendix. Candidate therapies can be added to the protocol and previous candidates removed from further investigation as evidence emerges. The trial will be monitored by an independent Data Monitoring Committee (DMC) to ensure patient safety. Each candidate cohort will include a small cohort of patients randomised to candidate therapy or existing standard of care management dependent on disease stage at entry. Cohort numbers will be defined in the protocol appendices. This is a Phase IIa experimental medicine trial and as such formal sample size calculations are not appropriate.
NCT04473053 COVID-19 Drug: Nafamostat Mesilate Drug: TD139 Other: Standard care
Primary Outcomes
Description: Measure vital signs (blood pressure/heart rate/temperature and respiratory rate)
Measure: The safety of the candidate therapies in COVID-19 patients by measuring physiological changes in the circulatory and respiratory system. Time: Up to 16 days post treatmentDescription: Record number of participants With treatment-related adverse events
Measure: The safety of the candidate therapies in COVID-19 patients by recording the number of treatment related adverse events. Time: Up to 90 days post treatmentSecondary Outcomes
Description: Measure maximum plasma concentration [Cmax] in blood samples.
Measure: Measuring the PK of the proposed trial treatments in COVID-19 patients. Time: 6 monthsDescription: Change in expression or activity of coagulation markers in serial blood samples taken before, during and after treatment.
Measure: Measure a change in the expression of key coagulation biomarkers in the blood of COVID-19 patients during and after treatment period. Time: 6 monthsDescription: Change in expression or activity of inflammatory cytokines in serial blood samples taken before, during and after treatment.
Measure: Measure a change in the expression of key cytokines in the blood of COVID-19 patients during and after treatment period. Time: 6 monthsDescription: Record changes in National Early Warning Score (NEWS) 2 score. Scale is from 0-20, with a higher number indicating a higher risk of morbidity.
Measure: To evaluate the improvement or deteroriation of patients in each treatment arm. Time: 16 daysDescription: Duration (days) of oxygen use
Measure: To evaluate the number of oxygen-free days. Time: 16 daysDescription: Duration (days) of ventilation
Measure: To evaluate incidence of any form of new ventilation use. Time: 16 daysDescription: Duration of ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use.
Measure: To evaluate ventilator-free days Time: 16 daysDescription: SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death
Measure: Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2) Time: 16 daysDescription: Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal/saliva swab while hospitalised on Days 1, 3, 5, 8, 11, 15.
Measure: To evaluate SARS-CoV-2 viral load. Time: 15 daysDescription: Duration of total hospital stay • Duration to discharge following treatment
Measure: To evaluate time to discharge Time: 16 daysDescription: Record requirement for renal dialysis or haemofiltration
Measure: To evaluate the use of renal dialysis or haemofiltration for each treatment arm. Time: 16 days