As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit.

GS-US-540-5774

Overall study
Study Sites (1)

Acronym	ISRCTN	EudraCT	NCT (clinicaltrials.gov)	DRKS
GS-US-540-5774		2020-000842-32	NCT04292730

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

Status: Active

Purpose / Objectives

Primary Outcome

To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11

Secondary Outcomes

To evaluate the safety and tolerability of RDV compared to SOC

Diagnosis

COVID-19 infection

Target population

Inclusion criteria

Willing and able to provide written informed consent (participants ≥18 years of age) or assent (participants ≥ 12 and < 18 years of age, where locally and nationally approved) prior to performing study procedures. For participants ≥12 and <18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures
Aged ≥ 18 years (at all sites), or aged ≥12 and <18 years of age weighing ≥40 kg (where permitted according to local law and approved nationally and by the relevant IRB/IEC)
SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
Currently hospitalized and requiring medical care for COVID-19
SpO2 > 94% on room air at screening
Radiographic evidence of pulmonary infiltrates
Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.

Exclusion criteria

Participation in any other clinical trial of an experimental agent treatment for COVID-19
Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
Requiring mechanical ventilation at screening
ALT or AST > 5 x ULN
Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age
Positive pregnancy test (Protocol Appendix 3)
Breastfeeding woman
Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Study design

Phase III
Open Label
Randomized

Intervention

Two part open-label study: part A consists of 3 treatment groups, part B is a single group

Part A: Remdesivir (RDV), 5 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

Part A: Remdesivir, 10 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Part A: Continued SOC Therapy

Participants will receive continued standard of care therapy.

Part B: Extension Treatment, Remdesivir 5 or 10 days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Clinical Trials