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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:

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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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