ACTIV-2: A Study for Outpatients With COVID-19

Summary

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Conditions

• Coronavirus
• Covid19

Interventions

BIOLOGICAL

bamlanivimab 7000mg

Administered by single IV infusion. Participants are no longer being randomized to this intervention.

BIOLOGICAL

BRII-196+BRII-198

1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.

BIOLOGICAL

AZD7442 (IV)

300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.

BIOLOGICAL

AZD7442 (IM)

Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.

DRUG

SNG001

1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.

DRUG

Camostat

200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.

BIOLOGICAL

BMS-986414 + BMS-986413

Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.

BIOLOGICAL

SAB-185 (3,840 Units/kg)

Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.

BIOLOGICAL

SAB-185 (10,240 Units/kg)

Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.

DRUG

CASIRIVIMAB + IMDEVIMAB

600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.

DRUG

Placebo for Bamlanivimab 7000mg

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for Bamlanivimab 700mg

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for BRII-196+BRII-198

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for SNG001

Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.

DRUG

Placebo for Camostat

200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.

DRUG

Placebo for SAB-185 (low dose)

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for BMS-986414 + BMS-986413

Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.

DRUG

Placebo for AZD7442 (IV)

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for AZD7442 (IM)

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

DRUG

Placebo for SAB-185 (high dose)

Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

BIOLOGICAL

bamlanivimab 700mg

Administered by single IV infusion. Participants are no longer being randomized to this intervention.

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

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

  collaborator NETWORK

• Brii Biosciences Limited

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Sagent Pharmaceuticals

  collaborator INDUSTRY

• Synairgen Research Ltd.

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• SAb Biotherapeutics, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• David Smith, MD, MAS · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-19

Primary Completion

2022-04-07

Completion

2023-06-20

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• Canada
• Guatemala
• Mexico
• Philippines
• Puerto Rico
• South Africa

Study Locations