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GS-US-540-5773

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
GS-US-540-57732020-000841-15NCT04292899

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

Patient attributes

Inclusion criteria

  1. 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
  2. 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])
  3. SARS-CoV-2 infection confirmed by PCR ≤ 4 days before  randomization
  4. Currently hospitalized
  5. SpO2 > 94% on room air or requiring supplemental oxygen at  screening
  6. Radiographc evidence of pulmonary infiltrates
  7. 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

  1. Participation in any other clinical trial of an experimental treatment for COVID-19
  2. 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
  3. Evidence of multiorgan failure
  4. Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO.
  5. ALT or AST > 5 x upper limit of normal (ULN)
  6. 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
  7. Positive pregnancy test (Protocol; Appendix 3)
  8. Breastfeeding woman
  9. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Trial design

  • Phase III
  • Randomized
  • Parallel
  • Open Label

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

 

Documents (password protected)

Responsibilities in overall trial

Gilead Sciences, Inc.