Covid 19 Research using Clinical Trials (Home Page)
RemdesivirWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (51)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2414 | Remdesivir placebo Wiki | 0.32 |
| drug629 | Cenicriviroc Wiki | 0.23 |
| drug2897 | Therapeutic Plasma exchange Wiki | 0.23 |
| drug1325 | Hydroxychloroquine, Azithromycin Wiki | 0.23 |
| drug1648 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg Wiki | 0.23 |
| drug2383 | Recombinant Human Interferon α2b Spray Wiki | 0.23 |
| drug1728 | Merimepodib Wiki | 0.23 |
| drug523 | COVICU Wiki | 0.23 |
| drug2375 | Razuprotafib Wiki | 0.23 |
| drug1436 | Interferon beta-1a Wiki | 0.23 |
| drug761 | Convalescent Serum Wiki | 0.23 |
| drug1649 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg Wiki | 0.23 |
| drug561 | COVID-19 exposure Wiki | 0.23 |
| drug1373 | Icatibant Wiki | 0.23 |
| drug1329 | Hydroxychloroquine, Doxycycline Wiki | 0.23 |
| drug1650 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg Wiki | 0.23 |
| drug247 | Apremilast Wiki | 0.23 |
| drug3398 | oxygen treatment Wiki | 0.23 |
| drug411 | Biological sample and clinical data collection Wiki | 0.23 |
| drug129 | Abivertinib Wiki | 0.23 |
| drug2341 | RIA-device (Remote Investigation and Assessment) Wiki | 0.23 |
| drug1326 | Hydroxychloroquine, Clindamycin Wiki | 0.23 |
| drug2836 | Technology based social interactions Wiki | 0.23 |
| drug1438 | Interferon-Alpha2B Wiki | 0.23 |
| drug1328 | Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki | 0.23 |
| drug1734 | Mesenchymal stem cell therapy Wiki | 0.23 |
| drug1327 | Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki | 0.23 |
| drug1895 | No research related technology based social interactions Wiki | 0.23 |
| drug2 | (Standard of Care) SoC Wiki | 0.23 |
| drug480 | Bromhexine Hydrochloride Tablets Wiki | 0.23 |
| drug250 | Arbidol Hydrochloride Granules Wiki | 0.23 |
| drug1689 | Matching Placebo Wiki | 0.16 |
| drug2070 | Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki | 0.16 |
| drug2698 | Standard of Care Wiki | 0.12 |
| drug2928 | Tocilizumab Wiki | 0.12 |
| drug1543 | LY3819253 Wiki | 0.11 |
| drug1433 | Interferon Beta-1A Wiki | 0.11 |
| drug3235 | convalescent plasma Wiki | 0.11 |
| drug2427 | Reslizumab Wiki | 0.11 |
| drug1727 | Mepolizumab Wiki | 0.11 |
| drug1638 | Lung ultrasound Wiki | 0.10 |
| drug2122 | Placebo Wiki | 0.09 |
| drug376 | Baricitinib Wiki | 0.09 |
| drug1607 | Losartan Wiki | 0.08 |
| drug1605 | Lopinavir/ritonavir Wiki | 0.07 |
| drug1743 | Methylprednisolone Wiki | 0.06 |
| drug2707 | Standard of care Wiki | 0.05 |
| drug1087 | Favipiravir Wiki | 0.05 |
| drug752 | Convalescent Plasma Wiki | 0.05 |
| drug1284 | Hydroxychloroquine Wiki | 0.05 |
| drug2311 | Questionnaire Wiki | 0.04 |
Correlated MeSH Terms (17)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008569 | Memory Disorders NIH | 0.23 |
| D004408 | Dysgeusia NIH | 0.13 |
| D009202 | Cardiomyopathies NIH | 0.13 |
| D000544 | Alzheimer Disease NIH | 0.11 |
| D003289 | Convalescence NIH | 0.10 |
| D018352 | Coronavirus Infections NIH | 0.10 |
| D060825 | Cognitive Dysfunction NIH | 0.07 |
| D000857 | Olfaction Disorders NIH | 0.06 |
| D016638 | Critical Illness NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D007239 | Infection NIH | 0.05 |
| D002318 | Cardiovascular Diseases NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.03 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.02 |
Correlated HPO Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002354 | Memory impairment HPO | 0.23 |
| HP:0001638 | Cardiomyopathy HPO | 0.13 |
| HP:0002511 | Alzheimer disease HPO | 0.11 |
| HP:0001268 | Mental deterioration HPO | 0.07 |
| HP:0000458 | Anosmia HPO | 0.06 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.04 |
| HP:0002090 | Pneumonia HPO | 0.03 |
There are 19 clinical trials
Clinical Trials
1 A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Mild and Moderate COVID-19.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate COVID-19.
NCT04252664 COVID-19 SARS-CoV-2 Drug: Remdesivir Drug: Remdesivir placebo
Primary Outcomes
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalisation and alleviation criteria: Fever - <37°C, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 daysSecondary Outcomes
Description: baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Measure: All cause mortality Time: up to 28 daysDescription: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measure: Frequency of respiratory progression Time: up to 28 daysMeasure: Time to defervescence (in those with fever at enrolment) Time: up to 28 days
Measure: Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) Time: up to 28 days
Measure: Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnoea at enrolment rated as severe or moderate,) Time: up to 28 days
Measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation Time: up to 28 days
Measure: Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen Time: up to 28 days
Measure: Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve. Time: up to 28 days
Measure: Frequency of requirement for mechanical ventilation Time: up to 28 days
Measure: Frequency of serious adverse events Time: up to 28 days
2 A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Severe COVID-19.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with severe COVID-19.
NCT04257656 COVID-19 Remdesivir SARS-CoV-2 Drug: Remdesivir Drug: Remdesivir placebo
Primary Outcomes
Description: The primary endpoint is time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 ꞊ discharged; 6 ꞊ death) or live discharge from hospital. Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Measure: Time to Clinical Improvement (TTCI) [Censored at Day 28] Time: up to 28 daysSecondary Outcomes
Description: Clinical status, assessed by the ordinal scale at fixed time points (days 7, 14, 21, and 28).
Measure: Clinical status Time: days 7, 14, 21, and 28Description: Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
Measure: Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours. Time: up to 28 daysMeasure: All cause mortality Time: up to 28 days
Measure: Duration (days) of mechanical ventilation Time: up to 28 days
Measure: Duration (days) of extracorporeal membrane oxygenation Time: up to 28 days
Measure: Duration (days) of supplemental oxygenation Time: up to 28 days
Measure: Length of hospital stay (days) Time: up to 28 days
Measure: Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens Time: up to 28 days
Measure: Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. Time: up to 28 days
Measure: Frequency of serious adverse drug events Time: up to 28 days
3 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.
NCT04280705 COVID-19 Other: Placebo Drug: Remdesivir
Primary Outcomes
Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Measure: Time to recovery Time: Day 1 through Day 29Secondary Outcomes
Measure: Change from baseline in alanine transaminase (ALT) Time: Day 1 through Day 29Measure: Change from baseline in aspartate transaminase (AST) Time: Day 1 through Day 29
Measure: Change from baseline in creatinine Time: Day 1 through Day 29
Measure: Change from baseline in glucose Time: Day 1 through Day 29
Measure: Change from baseline in hemoglobin Time: Day 1 through Day 29
Measure: Change from baseline in platelets Time: Day 1 through Day 29
Measure: Change from baseline in prothrombin time (PT) Time: Day 1 through Day 29
Measure: Change from baseline in total bilirubin Time: Day 1 through Day 29
Measure: Change from baseline in white blood cell count (WBC) with differential Time: Day 1 through Day 29
Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) from baseline Time: Day 1 through Day 29Description: 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: Clinical status using ordinal scale Time: Day 3 through Day 29Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Time: Day 1 through Day 29Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measure: Cumulative incidence of serious adverse events (SAEs) Time: Day 1 through Day 29Description: For any reason.
Measure: Discontinuation or temporary suspension of investigational therapeutics Time: Day 1 through Day 10Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Measure: Incidence of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29
Measure: Incidence of new oxygen use Time: Day 1 through Day 29
Measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29
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: Mean change in the ordinal scale Time: Day 1 through Day 29Description: 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: Percentage of subjects reporting each severity rating on an 8-point ordinal scale Time: Day 15Description: Date and cause of death (if applicable).
Measure: Subject 14-day mortality Time: Day 1 through Day 15Description: Date and cause of death (if applicable).
Measure: Subject 29-day mortality Time: Day 1 through Day 29Description: 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: Time to an improvement of one category using an ordinal scale Time: Day 1 through Day 29Description: 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: Time to an improvement of two categories using an ordinal scale Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 294 A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.
NCT04292730 COVID-19 Drug: Remdesivir Drug: Standard of Care
Primary Outcomes
Description: The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. 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 low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized.
Measure: The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 Time: Day 11Secondary Outcomes
Measure: Proportion of Participants experiencing Treatment-Emergent Adverse Events Time: First dose date up to 10 days plus 30 days5 A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
NCT04292899 COVID-19 Drug: Remdesivir Drug: Standard of Care
Primary Outcomes
Description: The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. 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 low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized.
Measure: The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 14 Time: Day 14Secondary Outcomes
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to 10 days plus 30 days6 Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
NCT04302766 Coronavirus Disease 2019 Drug: Remdesivir MeSH:Coronavirus Infections
7 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 (this treatment arm has been ceased since June 29, 2020) + Lopinavir/Ritonavir plus interferon ß-1a versus SoC (this treatment arm has been ceased since June 29, 2020) + Hydroxychloroquine (this treatment arm has been ceased since May 24, 2020). 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
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. Time to an improvement of two categories from admission on an ordinal scale. Time to discharge (categories 1 or 2 of ordinal scale) from admission. 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 118 The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.
NCT04321616 SARS-CoV Infection COVID 19 Acute Respiratory Distress Syndrome ARDS Drug: Hydroxychloroquine Drug: Remdesivir Other: (Standard of Care) SoC MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury
Primary Outcomes
Description: All cause in-hospital mortality
Measure: In-hospital mortality Time: 3 weeksSecondary Outcomes
Measure: Occurrence and duration of mechanical ventilation Time: 3 weeksMeasure: Occurrence and duration of intensive care unit (ICU) treatment Time: 3 weeks
Measure: Duration of hospital admittance Time: 1 month
Measure: 28 Day mortality Time: 3 weeks
Measure: Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen Time: 3 weeks
Measure: Occurrence of co-infections Time: 3 weeks
Measure: Occurrence of organ dysfunction Time: 3 months
Other Outcomes
Measure: Inflammatory and anti-inflammatory mediators as assessed in serum and plasma Time: Throughout hospitalizationMeasure: Markers of extracellular matrix remodeling Time: Throughout hospitalization and 3 months after remission
Measure: Markers of endothelial activation Time: Throughout hospitalization
Measure: Markers of platelet activation Time: Throughout hospitalization
9 Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection
The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
NCT04323761 SARS-CoV2 Infection Drug: Remdesivir MeSH:Infection Communicable Diseases
10 The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level. The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases. The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.
NCT04349410 CoVid 19 Positive Drug: Hydroxychloroquine, Azithromycin Drug: Hydroxychloroquine, Doxycycline Drug: Hydroxychloroquine, Clindamycin Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose. Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose. Drug: Remdesivir Drug: Tocilizumab Drug: Methylprednisolone Drug: Interferon-Alpha2B Drug: Losartan Drug: Convalescent Serum
Primary Outcomes
Description: Measured improvement in tissue as measured using FMTVDM
Measure: Improvement in FMTVDM Measurement with nuclear imaging. Time: 72 hoursSecondary Outcomes
Description: Extubation
Measure: Ventilator status Time: 7 daysDescription: Self explanatory
Measure: Survival status Time: 30 days11 Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.
This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.
NCT04365725 COVID-19 Drug: Remdesivir MeSH:Infection
Primary Outcomes
Description: Study the prognostic factors of the clinical course of patients on Day 15 under treatment with remdesivir. Clinical progress will be categorized using a 7-point ordinal scale.
Measure: Clinical course on Day 15. Time: 15 daysSecondary Outcomes
Description: Explore the prognostic factors of the clinical course of patients on Day 3
Measure: Clinical course on Day 3. Time: 3 daysDescription: Explore the prognostic factors of the clinical course of patients on Day 8
Measure: Clinical course on Day 8 Time: 8 daysDescription: Explore the prognostic factors of the clinical course of patients on Day11
Measure: Clinical course on Day 11. Time: 11 daysDescription: Explore the prognostic factors of the clinical course of patients on D29.
Measure: Clinical course on Day 29. Time: 29 daysDescription: Duration of treatment with remdesivir
Measure: Duration of treatment Time: 29 daysDescription: PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; Glasgow score; creatinine.
Measure: Sepsis-related Organ Failure Assessment score Time: Day 3, 8, 11, 15 and 29Description: Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir
Measure: Duration without mechanical ventilation Time: 29 daysDescription: Mortality at 29 days after initiation of treatment with remdesivir.
Measure: Mortality Time: 29 daysDescription: Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).
Measure: cumulative incidence of grade 3 and 4 adverse events (AEs). Time: 29 days12 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-2)
ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
NCT04401579 COVID-19 Other: Placebo Drug: Remdesivir Drug: Baricitinib
Primary Outcomes
Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Measure: Time to recovery Time: Day 1 through Day 29Secondary Outcomes
Measure: Change from baseline in alanine transaminase (ALT) Time: Day 1 through Day 29Measure: Change from baseline in aspartate transaminase (AST) Time: Day 1 through Day 29
Measure: Change from baseline in creatinine Time: Day 1 through Day 29
Measure: Change from baseline in glucose Time: Day 1 through Day 29
Measure: Change from baseline in hemoglobin Time: Day 1 through Day 29
Measure: Change from baseline in platelets Time: Day 1 through Day 29
Description: PT reported as international normalized ratio (INR).
Measure: Change from baseline in prothrombin time (PT) Time: Day 1 through Day 29Measure: Change from baseline in total bilirubin Time: Day 1 through Day 29
Measure: Change from baseline in white blood cell count (WBC) with differential Time: Day 1 through Day 29
Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) from baseline Time: Day 1 through Day 29Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Time: Day 1 through Day 29Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measure: Cumulative incidence of serious adverse events (SAEs) Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Description: Measured in days
Measure: Duration of oxygen use Time: Day 1 through Day 29Description: For any reason.
Measure: Incidence of discontinuation or temporary suspension of investigational therapeutics Time: Day 1 through Day 10Measure: Incidence of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29
Measure: Incidence of new oxygen use Time: Day 1 through Day 29
Measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29
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: Mean change in the ordinal scale Time: Day 1 through Day 29Description: 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: Participant's clinical status at Day 15 by ordinal scale Time: Day 15Description: 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: Percentage of subjects reporting each severity rating on an 8 point ordinal scale Time: Days 3, 5, 8, 11, 22, and 29Description: Date and cause of death (if applicable).
Measure: Subject 14-day mortality Time: Day 1 through Day 15Description: Date and cause of death (if applicable).
Measure: Subject 28-day mortality Time: Day 1 through Day 29Description: 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: Time to an improvement of one category using an ordinal scale Time: Day 1 through Day 29Description: 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: Time to an improvement of two categories using an ordinal scale Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 29Measure: Change from baseline in C-reactive protein (CRP) Time: Day 1 through Day 29
Measure: Change from baseline in d-dimer concentration Time: Day 1 through Day 29
13 A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.
NCT04409262 COVID-19 Pneumonia Drug: Remdesivir Drug: Tocilizumab Drug: Placebo MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Measure: Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Day 28 Time: Day 28
Secondary Outcomes
Measure: Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of Time: Up to Day 28
Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status Time: Up to Day 28
Measure: Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Days 7, 14, and 21 Time: Days 7, 14, and 21
Measure: Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline Time: Up to Day 28
Measure: Ventilator-Free Days from Randomization to Day 28 Time: Up to Day 28
Measure: Proportion of Participants Requiring Initiation of Intensive Care Unit (ICU) Care Post-baseline Time: Up to Day 28
Measure: Duration of ICU Stay in Days Time: Up to Day 28
Description: For participants entering the study already in ICU or on mechanical ventilation, clinical failure is defined as a one-category worsening on the ordinal scale, withdrawal or death.
Measure: Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) Time: Up to Day 28
Measure: Mortality Rate on Days 7, 14, 21, 28, and 60 Time: Days 7, 14, 21, 28, and 60
Measure: Time to Recovery, Defined as Time from Randomization to the Time when a Category of 2, Non-ICU Hospital Ward (or "Ready for Hospital Ward") not Requiring Supplemental Oxygen, or Better is Observed Time: Up to Day 28
Measure: Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or Time: Up to Day 28
Measure: Duration of Supplemental Oxygen Use Time: Up to Day 28
Other Outcomes
Measure: Percentage of Participants with Adverse Events (AEs) Time: Up to Day 28
Measure: Proportion of Participants with any Post-Treatment Infection Time: Up to Day 28
Measure: Plasma Concentration of Remdesivir Time: Up to Day 28
14 A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)
Primary Outcomes
Measure: Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Day 28 Time: Day 28Secondary Outcomes
Measure: Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of Time: Up to Day 28Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status Time: Up to Day 28
Measure: Clinical Status as Assessed by the Investigator Using a 7-Category Ordinal Scale of Clinical Status on Days 7, 14, and 21 Time: Days 7, 14, and 21
Measure: Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline Time: Up to Day 28
Measure: Ventilator-Free Days from Randomization to Day 28 Time: Up to Day 28
Measure: Proportion of Participants Requiring Initiation of Intensive Care Unit (ICU) Care Post-baseline Time: Up to Day 28
Measure: Duration of ICU Stay in Days Time: Up to Day 28
Description: For participants entering the study already in ICU or on mechanical ventilation, clinical failure is defined as a one-category worsening on the ordinal scale, withdrawal or death.
Measure: Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) Time: Up to Day 28Measure: Mortality Rate on Days 7, 14, 21, 28, and 60 Time: Days 7, 14, 21, 28, and 60
Measure: Time to Recovery, Defined as Time from Randomization to the Time when a Category of 2, Non-ICU Hospital Ward (or "Ready for Hospital Ward") not Requiring Supplemental Oxygen, or Better is Observed Time: Up to Day 28
Measure: Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or Time: Up to Day 28
Measure: Duration of Supplemental Oxygen Use Time: Up to Day 28
Other Outcomes
Measure: Percentage of Participants with Adverse Events (AEs) Time: Up to Day 28Measure: Proportion of Participants with any Post-Treatment Infection Time: Up to Day 28
Measure: Plasma Concentration of Remdesivir Time: Up to Day 28
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.
NCT04410354 COVID-19 Drug: Merimepodib Drug: Matching Placebo Drug: Remdesivir
Primary Outcomes
Description: Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure
Measure: Number of subjects not hospitalized or, if hospitalized, free of respiratory failure Time: Day 0 to Day 28Description: Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug
Measure: Adverse Events Time: Day 0 to Day 56Secondary Outcomes
Description: Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities
Measure: National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale Time: Day 0 to Day 28Description: Duration of fever
Measure: Temperature Time: Day 0 to Day 37Description: Number of deaths
Measure: Death Time: Day 0 to Day 56Description: Need and duration of mechanical ventilation
Measure: Mechanical ventilation Time: Day 0 to Day 56Description: Duration of vasopressor support
Measure: Vasopressor Support Time: Day 0 to Day 56Description: Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula
Measure: Oxygen Therapy Time: Day 0 to Day 37Description: Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test
Measure: Cessation of Viral Shedding Time: Day 0 to Day 37Description: Change in SpO2/FiO2
Measure: Change in Oxygen Saturation/Fraction of Inspired Oxygen Time: Day 0 to Day 3715 A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19
The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
NCT04431453 COVID-19 Drug: Remdesivir
Primary Outcomes
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up AssessmentMeasure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up Assessment
Description: Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.
Measure: Plasma Concentrations of Remdesivir (RDV) and Metabolites Time: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hoursSecondary Outcomes
Measure: Change From Baseline in Oxygenation Use Time: Baseline, up to Day 30 Follow-up AssessmentMeasure: Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Time: Baseline, up to Day 30 Follow-up Assessment
Description: The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. 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 low flow supplemental oxygen 5.) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6.) Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration) 7.) Not hospitalized.
Measure: Clinical Improvement on a 7-point Ordinal Scale Time: First dose date up to 10 daysMeasure: Time (days) to Discharge From Hospital Time: First dose date up to Day 30 Follow-up Assessment
Description: Confirmed negative PCR is defined by 2 consecutive negative PCR results.
Measure: Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result Time: First dose date up to 10 daysMeasure: Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Time: Baseline, up to 10 days or up to the first confirmed negative PCR results (whichever comes first)
Measure: Bilirubin Concentrations in < 14-day-old Participants Time: First dose date up to 10 days
Description: The PEWS is measured by 3 components, including 1.) behavior, 2.) perfusion assessed by capillary refill and heart rate, and 3.) respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranges between zero to 9 point, with 9 point representing the highest severity level.
Measure: Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale Time: First dose date up to 10 daysDescription: Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.
Measure: Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) Time: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hoursMeasure: Proportion of Participants With Concomitant Use of Medications other than RDV for Treatment of Coronavirus Disease 2019 (COVID-19) Time: First dose date up to Day 30 Follow-up Assessment
16 I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients
The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.
NCT04488081 COVID-19 Drug: Remdesivir Drug: Cenicriviroc Drug: Icatibant Drug: Razuprotafib Drug: Apremilast MeSH:Critical Illness
Primary Outcomes
Description: Time to achieve durable change in COVID-19 to ordinal level 4 or less for at least 48 hours
Measure: Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19 Time: Up to 28 daysSecondary Outcomes
Description: % of COVID-19 level 5 who never progress to COVID-19 level 6/7
Measure: Improvement in disease severity Time: Up to 60 daysDescription: Ventilator-free Days
Measure: Health care utilization Time: Up to 60 daysDescription: Total grade 3 or higher AEs by arm and total number of patients with grade 3 or higher AEs by arm. ● Total grade 3 or higher AEs of special interest by arm and total number of patients with grade 3 or higher AEs of special interest by arms (based upon lab assessments)
Measure: Frequency of serious AEs Time: Up to 60 daysDescription: Mortality at 28 days after study enrollment
Measure: Mortality Time: Up to 28 days17 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-3)
ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
NCT04492475 COVID-19 Drug: Interferon beta-1a Other: Placebo Drug: Remdesivir
Primary Outcomes
Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Measure: Time to recovery Time: Day 1 through Day 29Secondary Outcomes
Measure: Change from baseline in alanine aminotransferase (ALT) Time: Day 1 through Day 29Measure: Change from baseline in aspartate aminotransferase (AST) Time: Day 1 through Day 29
Measure: Change from baseline in C-reactive protein (CRP) Time: Day 1 through Day 29
Measure: Change from baseline in creatinine Time: Day 1 through Day 29
Measure: Change from baseline in d-dimer concentration Time: Day 1 through Day 29
Measure: Change from baseline in hemoglobin Time: Day 1 through Day 29
Measure: Change from baseline in international normalized ratio (INR) Time: Day 1 through Day 29
Measure: Change from baseline in platelets Time: Day 1 through Day 29
Measure: Change from baseline in total bilirubin Time: Day 1 through Day 29
Measure: Change from baseline in white blood cell count (WBC) with differential Time: Day 1 through Day 29
Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) from baseline Time: Day 1 through Day 29Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Time: Day 1 through Day 29Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measure: Cumulative incidence of serious adverse events (SAEs) Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of invasive mechanical ventilation Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of non invasive ventilation/high flow oxygen use Time: Day 1 through Day 29Description: Measured in days
Measure: Duration of oxygen use Time: Day 1 through Day 29Description: For any reason.
Measure: Incidence of discontinuation or temporary suspension of investigational therapeutics Time: Day 1 through Day 10Measure: Incidence of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29
Measure: Incidence of new oxygen use Time: Day 1 through Day 29
Measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29
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: Mean change in the ordinal scale Time: Day 1 through Day 29Description: 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: Participant's clinical status at Day 15 by ordinal scale Time: Day 15Description: 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: Percentage of subjects reporting each severity rating on an 8 point ordinal scale Time: Days 3, 5, 8, 11, 22, and 29Description: Date and cause of death (if applicable).
Measure: Subject 14-day mortality Time: Day 1 through Day 15Description: Date and cause of death (if applicable).
Measure: Subject 28-day mortality Time: Day 1 through Day 29Description: 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: Time to an improvement of one category using an ordinal scale Time: Day 1 through Day 29Description: 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: Time to an improvement of two categories using an ordinal scale Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 29Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Measure: Time to recovery for participants not on mechanical ventilation (baseline ordinal score of 4, 5, or 6) Time: Day 1 through Day 2918 Role of Investigational Therapies Alone or in Combination to Treat Moderate, Severe and Critical COVID-19
Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).Investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going to quarantine or dying after exposure to large doses of viral inoculums. Investigators recommend that institutions should register for Clinical trials and consider emergency use of TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available evidence, preferably as part of clinical trial.Since the outbreak of corona virus disease (COVID-19), main treatment modalities have been antivirals, interferons, glucocorticoids, anti-coagulants and supportive treatment in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline / chloroquine sulphate, azithromycin, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small and remain in the experimental phase with currently no effective / specific antiviral with robust scientific evidence as regards the mortality reduction in COVID-19.In an attempt to treat COVID-19, investigator will use different investigational treatment either alone or in combination to see mortality and morbidity benefit on the basis of limitted evidence available so far. These investigational modalities include Therapeutic plasma exchange (TPE), Convalescent Plasma (CP), Remdesivir, Tocilizumab and Mesenchymal stem cell (MSC) therapy in addition to standard supportive treatment.
NCT04492501 Covid19 Cytokine Release Syndrome Critical Illness ARDS Procedure: Therapeutic Plasma exchange Biological: Convalescent Plasma Drug: Tocilizumab Drug: Remdesivir Biological: Mesenchymal stem cell therapy MeSH:Critical Illness
Primary Outcomes
Description: death or recovery
Measure: survival Time: 28 daysSecondary Outcomes
Description: duration in days
Measure: duration of hospitalization Time: 28 daysDescription: duration in days to normalize symptoms and laboratory parameters
Measure: Time to resolution of cytokine release storm Time: 28 daysDescription: Time in days to turn PCR negative
Measure: Time of viral clearance Time: 45 daysDescription: incidence of Post Covid lung fibrosis
Measure: Complications Time: 90 days19 A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
NCT04501978 Covid19 Drug: LY3819253 Drug: Placebo Drug: Remdesivir
Primary Outcomes
Description: Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Measure: Pulmonary ordinal outcome (Stage 1) Time: Day 5Description: Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Measure: Pulmonary+ ordinal outcome (Stage 1) Time: Day 5Description: Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Measure: Time from randomization to sustained recovery (Stage 2) Time: Up to Day 90Secondary Outcomes
Measure: All-cause mortality Time: Thru Day 90Measure: Composite of time to sustained recovery and mortality Time: Thru Day 90
Measure: Days alive outside short-term acute care hospital Time: Up to Day 90
Description: Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Measure: Pulmonary ordinal outcome Time: Days 1-7, 14 and 28Description: Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Measure: Pulmonary+ ordinal outcome Time: Days 1-7Description: Total of: Respiratory rate (breaths per minute) scored from 0 to +3; Oxygen saturation (%) scored from 0 to +3; Any supplemental oxygen scored from 0 to +2; Temperature scored from 0 to +3; Systolic BP scored from 0 to +3; Heart rate (beats per minute) scored from 0 to +3.; and AVPU (alert, voice, pain, unresponsive) scored from 0 to +3. A higher score denotes a worse outcome.
Measure: Change in New Early Warning (NEW) Score Time: Baseline to Day 5Measure: Incidence of clinical organ failure Time: Thru Day 28
Measure: Composite of death or serious clinical COVID-19 related events Time: Thru Day 90
Measure: Composite of cardiovascular events and thromboembolic events Time: Thru Day 90
Measure: Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death Time: Thru Days 5 and 28
Measure: Incidence of infusion reactions Time: Thru Day 0
Measure: Composite of SAEs or death Time: Thru Day 90
Measure: Change in SARS-CoV-2 neutralizing antibody levels Time: Baseline to Days 1, 3, 5, 28 and 90
Measure: Change in overall titers of antibodies Time: Baseline to Days 1, 3, 5, 28 and 90
Measure: Change in neutralizing antibody levels Time: Baseline to Days 1, 3, 5, 28 and 90