Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Remdesivir (RDV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04539262

GS-US-553-9020

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
• 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
• COVID-19 symptom onset ≤ 7 days prior to randomization
• Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air

Key Exclusion Criteria:

• 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) RDV or administration of any SARS-CoV-2 (or COVID-19) vaccine

  • Participants 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 8 patient groups, including a placebo group

Remdesivir (RDV), Part A

Experimental group

Description:

Participants will receive inhaled RDV 31 mg administered daily for 5 days.

Treatment:

Drug: Remdesivir (RDV)

RDV + Placebo, Part A

Experimental group

Description:

Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days.

Treatment:

Drug: Remdesivir (RDV)

Drug: Placebo

Placebo, Part A

Placebo Comparator group

Description:

Participants will receive placebo to match inhaled RDV in Part A daily for 5 days.

Treatment:

Drug: Placebo

RDV, Part B

Experimental group

Description:

Participants will receive inhaled RDV 62 mg administered daily for up to 5 days.

Treatment:

Drug: Remdesivir (RDV)

RDV + Placebo, Part B

Experimental group

Description:

Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days.

Treatment:

Drug: Remdesivir (RDV)

Drug: Placebo

Placebo, Part B

Placebo Comparator group

Description:

Participants will receive placebo to match inhaled RDV in Part B daily for 5 days.

Treatment:

Drug: Placebo

RDV, Part C

Experimental group

Description:

Participants will receive inhaled RDV 39 mg administered daily for 5 days.

Treatment:

Drug: Remdesivir (RDV)

Placebo, Part C

Placebo Comparator group

Description:

Participants will receive placebo to match inhaled RDV in Part C daily for 5 days.

Treatment:

Drug: Placebo