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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04257656
Other study ID # CAP-China remdesivir 2
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 6, 2020
Est. completion date April 10, 2020

Study information

Verified date April 2020
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.

Whilst the outbreak is likely to have started from a zoonotic transmission event associated with a large seafood market that also traded in live wild animals, it soon became clear that person-to-person transmission was also occurring. The number of cases of infection with COVID-19 identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Mathematical models of the expansion phase of the epidemic suggested that sustained person-to-person transmission is occurring, and the R-zero is substantially above 1, the level required for a self-sustaining epidemic in human populations.

The clinical spectrum of COVID-19 illness appears to be wide, encompassing asymptomatic infection, a mild upper respiratory tract infection, and severe viral pneumonia with respiratory failure and even death. Although the per infection risk of severe disease remains to be determined, case-fatality risk of 11-14% has been reported in several initial studies of seriously ill patients and case-fatality has been estimated approximately at 2% overall. Also the large number of cases in Wuhan has resulted in a large number of patients hospitalised with pneumonia requiring supplemental oxygen and sometimes more advance ventilator support.

This new coronavirus, and previous experiences with SARS and MERS-CoV, highlight the need for therapeutics for human coronavirus infections that can improve clinical outcomes, speed recovery, and reduce the requirements for intensive supportive care and prolonged hospitalisation.

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remdesivir
RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Remdesivir placebo
RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.

Locations

Country Name City State
China Bin Cao Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

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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