Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).

Official Title

A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

Details

This study will have multiple parts: Part A, Part B, and Part C. Part B will be conducted if supported by evaluation in healthy volunteers in another Phase 1a Gilead study (GS-US-553-9018). Participants in Part C will be enrolled after review of preliminary safety and available efficacy data from Parts A and B through at least Day 7. GS-US-553-9018 is a Phase 1a randomized, blinded, placebo-controlled, single- and multiple-dose study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of remdesivir administered by inhalation.

Keywords

COVID-19 Respiratory Aspiration Remdesivir (RDV)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection first confirmed by polymerase chain reaction (PCR) (Parts A and B) or by nucleic acid testing or direct antigen testing (Part C) with sample collected ≤ 4 days prior to randomization
  • Coronavirus disease 2019 (COVID-19) symptom onset ≤ 7 days prior to randomization
  • Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air

You CAN'T join if...

  • Ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for COVID-19
  • Prior or current hospitalization for COVID-19 or need for hospitalization
  • Treatment of COVID-19 with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including intravenous (IV) remdesivir (RDV) or administration of any SARS-CoV-2 (or COVID-19) vaccine
  • Patients chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded
  • Requiring oxygen supplementation
  • Positive pregnancy test
  • Breastfeeding female
  • Known hypersensitivity to the study treatment, its metabolites, or formulation excipient
  • Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (Parts A and B only)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC Davis Health/Medical Center
    Sacramento California 95817 United States
  • Aurora FDRC Inc.
    Costa Mesa California 92627 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • Elevated Health
    Huntington Beach California 92648 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04539262
Phase
Phase 1/2
Study Type
Interventional
Last Updated