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Remdesivir placeboWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug266 Azithromycin 500 milligram (mg) oral Tablet Wiki 0.71
drug2067 Remdesivir Wiki 0.37
drug2765 blood sample Wiki 0.29
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D018450 Disease Progression NIH 0.18
D014777 Virus Diseases NIH 0.09
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 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

No related HPO nodes (Using clinical trials)