COVID-19 Clinical Trial
Official title:
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.
Verified date | April 2020 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 237 |
Est. completion date | April 10, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years at time of signing Informed Consent Form 2. Laboratory (RT-PCR) confirmed COVID-19. 3. Lung involvement confirmed with chest imaging 4. Hospitalized with a SaO2/SPO2=94% on room air or Pa02/Fi02 ratio <300mgHg 5. =12 days since illness onset 6. Willingness of study participant to accept randomization to any assigned treatment arm. 7. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study. Exclusion Criteria: 1. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. 2. Severe liver disease (e.g. Child Pugh score = C, AST>5 times upper limit) 3. Pregnant or breastfeeding, or positive pregnancy test in a predose examination 4. Patients with known severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis 5. Will be transferred to another hospital which is not the study site within 72 hours. 6. Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation. |
Country | Name | City | State |
---|---|---|---|
China | Bin Cao | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Clinical Improvement (TTCI) [Censored at Day 28] | 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. |
up to 28 days | |
Secondary | Clinical status | Clinical status, assessed by the ordinal scale at fixed time points (days 7, 14, 21, and 28). | days 7, 14, 21, and 28 | |
Secondary | Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours. | Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours. | up to 28 days | |
Secondary | All cause mortality | up to 28 days | ||
Secondary | Duration (days) of mechanical ventilation | up to 28 days | ||
Secondary | Duration (days) of extracorporeal membrane oxygenation | up to 28 days | ||
Secondary | Duration (days) of supplemental oxygenation | up to 28 days | ||
Secondary | Length of hospital stay (days) | up to 28 days | ||
Secondary | Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens | up to 28 days | ||
Secondary | Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. | up to 28 days | ||
Secondary | Frequency of serious adverse drug events | up to 28 days |
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