Remdesivir Clinical Evidence Phase 3 Studies

Without a doubt, there is limited evidence to go off of for the treatment of SARS-CoV-2. While we continue to wrestle with the foundations of evidence-based medicine, we’re also recognizing the need to prioritize ongoing clinical trials and collectively assess and critically appraise the literature at hyper-speed. With that in mind, we must begin a review of the evidence before it is even published.

That is why I’ve outlined the ongoing Phase 3 studies of remdesivir as outlined on both the Gilead site as well as clinicatrials.gov.

Moderate Disease Gilead Study

“Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment” – ClinicalTrials.gov Identifier: NCT04292730

Design

Randomized, parallel assignment, open-label Phase 3 study.

Patients

Target population: 600 participants

Inclusion criteria:

  • Adults 18 Years and older, and able to provide written informed consent
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
  • Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
  • Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
  • Radiographic evidence of pulmonary infiltrates

Exclusion criteria:

  • Enrolled 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
  • Requiring mechanical ventilation at screening
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min

Intervention

Group 1: Remdesivir (RDV) for 5 Days + Standard care

  • Day 1: RDV 200 mg
  • Day 2-5: RDV 100 mg

Group 2: RDV for 10 days + Standard care

  • Day1: RDV 200 mg
  • Day 2-10: RDV 100 mg

Group 3: Standard care only

Comparison

Standard care: defined as therapy per local written guidelines or policies.

Outcome

  • Primary Outcome: the proportion of participants discharged by day 14
  • Secondary Outcome Measures: the proportion of participants treatment-emergent adverse events leading to study drug discontinuation

Status

Currently enrolling in the USA (California, Illinois, Washington, Massachusetts, Rhode Island), Hong Kong, South Korea, Taiwan, and Singapore.

Severe Disease Gilead Study

“Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)” – ClinicalTrials.gov Identifier: NCT04292899

Design:

Randomized, parallel assignment, open-label Phase 3 study.

Patients:

Target population: 400 participants

Inclusion criteria:

  • Adults 18 Years and older, and able to provide written informed consent
  • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
  • Currently hospitalized with fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
  • Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening
  • Radiographic evidence of pulmonary infiltrates

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
  • Requiring mechanical ventilation at screening
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Creatinine clearance < 50 mL/min

Intervention

Group 1: Remdesivir (RDV) for 5 Days + Standard care

  • Day 1: RDV 200 mg
  • Day 2-5: RDV 100 mg

Group 2: RDV for 10 days + Standard care

  • Day1: RDV 200 mg
  • Day 2-10: RDV 100 mg

Comparison

Active comparison between the two RDV regimens

Outcome

  • Primary Outcome: Composite outcome of the proportion of participants with normalization of fever and oxygen saturation through day 14. (fever normalization: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) > 94% sustained for at least 24 hours.)
  • Secondary Outcome Measures: the proportion of participants treatment-emergent adverse events leading to study drug discontinuation

Status

Currently enrolling in the USA (California, Illinois, Washington, Massachusetts, Rhode Island), Hong Kong, South Korea, Taiwan, and Singapore.
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