A Trial of Remdesivir in Adults With Mild and Moderate COVID-19

NCT04252664 | Suspended Phase 3 DMC

• 1 other identifier: CAP-China remdesivir 1
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Time to Clinical recoveryTime to Clinical Recovery (TTCR)

  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.

  up to 28 days

Secondary Outcomes (10)

• All cause mortality

  up to 28 days

• Frequency of respiratory progression

  up to 28 days

• Time to defervescence (in those with fever at enrolment)

  up to 28 days

• Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate)

  up to 28 days

• 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,)

  up to 28 days

Study Arms (2)

Remdesivir group

EXPERIMENTAL

active remdesivir

Drug: Remdesivir

Control group

PLACEBO COMPARATOR

Placebos matched remdesivir

Drug: Remdesivir placebo

Interventions

Remdesivir DRUG

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

Also known as: GS-5734

Remdesivir group

Remdesivir placebo DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at time of signing Informed Consent Form
• Laboratory (RT-PCR) confirmed COVID-19.
• Lung involvement confirmed with chest imaging
• Hospitalised with:
• Fever - ≥36.7℃ -axilla or Oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal or
• And at least one of Respiratory rate \>24/min Or Cough
• ≤8 days since illness onset
• Willingness of study participant to accept randomization to any assigned treatment arm.
• Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.

You may not qualify if:

• 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.
• Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
• SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio \<300mgHg
• Known allergic reaction to remdesivir
• 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
• Pregnant or breastfeeding, or positive pregnancy test in a predose examination
• Will be transferred to another hospital which is not the study site within 72 hours.
• Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.

Sponsors & Collaborators

• Capital Medical University: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Jin Yin-tan hospital

Wuhan, Hubei, 100013, China

Location

Related Publications (2)

• Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

  PMID: 36695483 DERIVED

• Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.

  PMID: 34350582 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 12, 2020
• Primary Completion: April 10, 2020
• Study Completion: April 27, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

CN (1)