ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Summary

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606)

Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)

Conditions

• Covid19

Interventions

BIOLOGICAL

Remdesivir

Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.

DRUG

Remdesivir Placebo

Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.

BIOLOGICAL

Aviptadil

Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr.

DRUG

Aviptadil Placebo

Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.

DRUG

Corticosteroid

In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Sponsors & Collaborators

• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

  collaborator NETWORK

• University of Copenhagen

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• Kirby Institute

  collaborator OTHER_GOV

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  collaborator NETWORK

• US Department of Veterans Affairs

  collaborator FED

• Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

  collaborator UNKNOWN

• NeuroRx, Inc.

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Samuel Brown, MD · Intermountain Medical Center/University of Utah

• Prof. James Neaton · INSIGHT Statistical and Coordinating Centre, University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-20

Primary Completion

2022-08-22

Completion

2022-11-20

FDA Drug

Yes

Countries

• United States

Study Locations