Clinical Trials
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-540-5773
- Overall study
- Study Sites (1)
Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
GS-US-540-5773 | 2020-000841-15 | NCT04292899 |
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
Status: Active
Purpose / Objectives
Primary Outcome
To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14
Secondary Outcomes
To evaluate the safety and tolerability of RDV
Diagnosis
- COVID-19 infection
Target population
Inclusion criteria
- Willing and able to provide written informed consent, or with a legal
representative who can provide informed consent, or enrolled under ICH
E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
investigator (participants ≥ 18 years of age), or willing and able to
provide 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 institutional review board [IRB] or independent ethics committee [IEC])
- SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
- Currently hospitalized
- SpO2 > 94% on room air or requiring supplemental oxygen at screening
- Radiographc 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 treatment for COVID-19
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
- Evidence of multiorgan failure
- Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO.
- ALT or AST > 5 x upper limit of normal (ULN)
- 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
- Parallel
Intervention
Part A: Remdesivir (RDV), 5 Days (Not Mechanically Ventilated)
Participants who are not mechanically ventilated 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 (Not Mechanically Ventilated)
Participants who are not mechanically ventilated 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 B: Remdesivir, 5 or 10 Days (Extension)
Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Part B: Remdesivir 10 days (Mechanically Ventilated)
Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
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