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History of Changes for Study: NCT04252664
A Trial of Remdesivir Treatment in Moderately Ill Patients With 2019-nCoV Infection
Latest version (submitted April 13, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2020 None (earliest Version on record)
2 February 3, 2020 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Design, Study Status, Study Description, Study Identification, Eligibility and Sponsor/Collaborators
3 February 20, 2020 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures and Oversight
4 April 13, 2020 Recruitment Status, Contacts/Locations, Study Status, Study Description, Study Identification, Eligibility, Outcome Measures and Conditions
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Study NCT04252664
Submitted Date:  January 31, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CAP-China remdesivir 1
Brief Title: A Trial of Remdesivir Treatment in Moderately Ill Patients With 2019-nCoV Infection
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 Moderately Ill 2019-nCoV Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Not yet recruiting
Study Start: February 3, 2020
Primary Completion: February 3, 2020 [Anticipated]
Study Completion: April 27, 2020 [Anticipated]
First Submitted: January 31, 2020
First Submitted that
Met QC Criteria:
January 31, 2020
First Posted: February 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 31, 2020
Last Update Posted: February 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Capital Medical University
Responsible Party: Principal Investigator
Investigator: Bin Cao
Official Title: Professor
Affiliation: China-Japan Friendship Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Given no specific antiviral therapy for 2019-nCoV infection and the ready availability of remdesvir as a potential antiviral agent, we conduct a randomized, controlled, double blind trial to evaluate the efficacy and safety of remdesivir in patients with 2019-nCoV pneumonia.
Detailed Description:
Open or close this module Conditions
Conditions: 2019-nCoV
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 270 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Remdesivir group
active remdesivir
Drug: Remdesivir
RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Placebo Comparator: Control group
Placebos matched remdesivir
Drug: Remdesivir
RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of composite advers outcomes
[ Time Frame: 14 days ]

Defined as SPO2≤ 94% without oxygen supplementation, PaO2/FiO2 <300mmHg or a respiratory rate ≤24 breaths per min without supplemental oxygen
Secondary Outcome Measures:
1. time to recovery
[ Time Frame: 28 days ]

Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen).
2. rate of no fever
[ Time Frame: 14 days ]

3. rate of no cough
[ Time Frame: 14 days ]

4. rate of no dyspnea
[ Time Frame: 14 days ]

5. rate of no requring supplemental oxygen
[ Time Frame: 14 days ]

6. rate of undectable viral RNA
[ Time Frame: 14 days ]

7. rate of mechanical ventilation
[ Time Frame: 28 days ]

8. rate of ICU admission
[ Time Frame: 28 days ]

9. rate of serious adverse event
[ Time Frame: 28 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age ≥18 years at time of signing Informed Consent Form
  2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV novel coronavirus.
  3. Lung involvement confirmed with chest imaging
  4. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
  5. Willingness of study participant to accept randomization to any assigned treatment arm.
  6. 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. SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg
  4. Known allergic reaction to remdesivir
  5. Pregnant or breastfeeding, or positive pregnancy test in a predose examination
  6. Will be transferred to another hospital which is not the study site within 72 hours
Open or close this module Contacts/Locations
Central Contact Person: Bin Cao, Professor
Telephone: +8613911318339
Email: caobin_ben@163.com
Central Contact Backup: Yeming Cao, Doctor
Email: wwyymm_love@163.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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