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RemdesivirWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (39)


Name (Synonyms) Correlation
drug2068 Remdesivir placebo Wiki 0.37
drug266 Azithromycin 500 milligram (mg) oral Tablet Wiki 0.26
drug1471 Merimepodib Wiki 0.26
drug1477 Mesenchymal stem cells Wiki 0.26
drug118 Active COVID-19 disease Wiki 0.26
drug1131 Hydroxychloroquine, Doxycycline Wiki 0.26
drug1528 Multifrequency Bioimpedance Spectroscopy Wiki 0.26
drug1855 Placebo solution Wiki 0.26
drug1479 Messaging Wiki 0.26
drug782 Docetaxel Wiki 0.26
drug1223 Interferon-Alpha2B Wiki 0.26
drug1533 MuscleSound Ultrasound Wiki 0.26
drug1130 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 0.26
drug1958 Q-NRG Metobolic Cart Device Wiki 0.26
drug1127 Hydroxychloroquine, Azithromycin Wiki 0.26
drug330 Berzosertib Wiki 0.26
drug656 Convalescent Serum Wiki 0.26
drug2065 Relaxation Therapy Wiki 0.26
drug2 (Standard of Care) SoC Wiki 0.26
drug1129 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 0.26
drug1319 Laboratory Biomarker Analysis Wiki 0.26
drug1128 Hydroxychloroquine, Clindamycin Wiki 0.26
drug522 Carboplatin Wiki 0.18
drug595 Cognitive Behavioral Therapy Wiki 0.18
drug960 Follow up Wiki 0.18
drug824 Eculizumab Wiki 0.18
drug1485 Methylprednisolone Sodium Succinate Wiki 0.18
drug1441 Matching Placebo Wiki 0.18
drug1219 Interferon Beta-1A Wiki 0.13
drug2765 blood sample Wiki 0.11
drug2319 Standard of Care Wiki 0.10
drug315 Baricitinib Wiki 0.10
drug2527 Tocilizumab Wiki 0.10
drug1374 Losartan Wiki 0.09
drug1372 Lopinavir/ritonavir Wiki 0.08
drug1484 Methylprednisolone Wiki 0.08
drug1822 Placebo Wiki 0.07
drug2326 Standard of care Wiki 0.06
drug1086 Hydroxychloroquine Wiki 0.05

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D001010 Anxiety, Separation NIH 0.26
D000072861 Phobia, Social NIH 0.26
D016584 Panic Disorder NIH 0.26
D000379 Agoraphobia NIH 0.26
D010698 Phobic Disorders NIH 0.18
D011471 Prostatic Neoplasms NIH 0.15
D002277 Carcinoma NIH 0.12
D018352 Coronavirus Infections NIH 0.11
D018450 Disease Progression NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D004194 Disease NIH 0.05
D001008 Anxiety Disorders NIH 0.04
D014777 Virus Diseases NIH 0.03
D011014 Pneumonia NIH 0.03
D007239 Infection NIH 0.03
D013577 Syndrome NIH 0.03
D055371 Acute Lung Injury NIH 0.03
D012127 Respiratory Distress Syndrome, Newborn NIH 0.03
D012128 Respiratory Distress Syndrome, Adult NIH 0.02
D003141 Communicable Diseases NIH 0.02

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000756 Agoraphobia HPO 0.26
HP:0012125 Prostate cancer HPO 0.15
HP:0030731 Carcinoma HPO 0.12
HP:0002090 Pneumonia HPO 0.03

There are 15 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 days

Secondary 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 days

Description: 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 days

Measure: 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 days

Secondary 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 28

Description: 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 days

Measure: 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 29

Secondary Outcomes

Measure: Change from baseline in alanine transaminase (ALT)

Time: Day 1 through Day 29

Measure: 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 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: Clinical status using ordinal scale

Time: Day 3 through Day 29

Description: 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 29

Description: 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 29

Description: For any reason.

Measure: Discontinuation or temporary suspension of investigational therapeutics

Time: Day 1 through Day 10

Description: Measured in days.

Measure: Duration of hospitalization

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 29

Measure: 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 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: Percentage of subjects reporting each severity rating on an 8-point ordinal scale

Time: Day 15

Description: Date and cause of death (if applicable).

Measure: Subject 14-day mortality

Time: Day 1 through Day 15

Description: Date and cause of death (if applicable).

Measure: Subject 29-day mortality

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: Time to an improvement of one category using an ordinal scale

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: Time to an improvement of two categories using an ordinal scale

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: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 29

4 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 11

Secondary Outcomes

Measure: Proportion of Participants experiencing Treatment-Emergent Adverse Events

Time: First dose date up to 10 days plus 30 days

5 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 14

Secondary Outcomes

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

Time: First dose date up to 10 days plus 30 days

6 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 15

Secondary 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 29

Description: • 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 29

Measure: 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 days

Description: Rate of mortality

Measure: Mortality

Time: In hospital, Day 28, Day 90

Measure: 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, 29

Measure: 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 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 hydroxychloroquine

Time: Days 1, 3, 5, 8 and 11

8 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 weeks

Secondary Outcomes

Measure: Occurrence and duration of mechanical ventilation

Time: 3 weeks

Measure: 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 hospitalization

Measure: 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 hours

Secondary Outcomes

Description: Extubation

Measure: Ventilator status

Time: 7 days

Description: Self explanatory

Measure: Survival status

Time: 30 days

11 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 days

Secondary Outcomes

Description: Explore the prognostic factors of the clinical course of patients on Day 3

Measure: Clinical course on Day 3.

Time: 3 days

Description: Explore the prognostic factors of the clinical course of patients on Day 8

Measure: Clinical course on Day 8

Time: 8 days

Description: Explore the prognostic factors of the clinical course of patients on Day11

Measure: Clinical course on Day 11.

Time: 11 days

Description: Explore the prognostic factors of the clinical course of patients on D29.

Measure: Clinical course on Day 29.

Time: 29 days

Description: Duration of treatment with remdesivir

Measure: Duration of treatment

Time: 29 days

Description: 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 29

Description: Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir

Measure: Duration without mechanical ventilation

Time: 29 days

Description: Mortality at 29 days after initiation of treatment with remdesivir.

Measure: Mortality

Time: 29 days

Description: 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 days

12 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 29

Secondary Outcomes

Measure: Change from baseline in alanine transaminase (ALT)

Time: Day 1 through Day 29

Measure: 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 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 29

Description: 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 29

Description: 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 29

Description: Measured in days.

Measure: Duration of hospitalization

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 29

Description: Measured in days

Measure: Duration of oxygen use

Time: Day 1 through Day 29

Description: For any reason.

Measure: Incidence of discontinuation or temporary suspension of investigational therapeutics

Time: Day 1 through Day 10

Measure: 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 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: Participant's clinical status at Day 15 by ordinal scale

Time: Day 15

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: Percentage of subjects reporting each severity rating on an 8 point ordinal scale

Time: Days 3, 5, 8, 11, 22, and 29

Description: Date and cause of death (if applicable).

Measure: Subject 14-day mortality

Time: Day 1 through Day 15

Description: Date and cause of death (if applicable).

Measure: Subject 28-day mortality

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: Time to an improvement of one category using an ordinal scale

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: Time to an improvement of two categories using an ordinal scale

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: Time to discharge or to a National Early Warning Score (NEWS) of 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 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)

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 28

Description: 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 56

Secondary 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 28

Description: Duration of fever

Measure: Temperature

Time: Day 0 to Day 37

Description: Number of deaths

Measure: Death

Time: Day 0 to Day 56

Description: Need and duration of mechanical ventilation

Measure: Mechanical ventilation

Time: Day 0 to Day 56

Description: Duration of vasopressor support

Measure: Vasopressor Support

Time: Day 0 to Day 56

Description: Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula

Measure: Oxygen Therapy

Time: Day 0 to Day 37

Description: 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 37

Description: Change in SpO2/FiO2

Measure: Change in Oxygen Saturation/Fraction of Inspired Oxygen

Time: Day 0 to Day 37

15 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 Assessment

Measure: 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 hours

Secondary Outcomes

Measure: Change From Baseline in Oxygenation Use

Time: Baseline, up to Day 30 Follow-up Assessment

Measure: 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 days

Measure: 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 days

Measure: 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 days

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 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 hours

Measure: 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


Related HPO nodes (Using clinical trials)