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

a study on COVID-19

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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. Participants in the study will be treated with either a study drug or with placebo.

Official Title

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

Details

This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The study is designed to transition from phase 2 to phase 3 in the same trial, with or without a pause in enrollment, depending on the speed of enrollment and interim results. For promising agents with limited availability, a phase 3 evaluation may occur at a later time. Up to two dose levels of the same agent may be assessed. Agents may also enter directly into phase 3 evaluation if sufficient safety and efficacy data are available from outside the trial.

Keywords

Coronavirus Covid19 COVID-19 COVID 19 Coronaviridae Infections Coronavirus Infections RNA Virus Infections Virus Diseases Nidovirales Infections SARS-CoV-2 SARS Coronavirus ACTIV-2 ACTIV2 ACTIV-2 Drug

Eligibility

You can join if…

Open to people ages 18 years and up

  • Signed informed consent.
  • Positive test for COVID-19 up to 7 days before participation in study.
  • Able to begin study treatment no later than 10 days from self-reported onset of

COVID-19 related symptom(s):

  • fever or feeling feverish
  • cough
  • shortness of breath or difficulty breathing at rest or when active
  • sore throat
  • body pain or muscle pain/aches
  • fatigue
  • headache
  • chills
  • blocked nose/nasal congestion
  • runny nose
  • loss of taste or smell
  • nausea or vomiting
  • diarrhea
  • temperature ≥ 38°C (100.4°F)
  • One or more of the following signs/symptoms within 48 hours of participating in the study:
  • fever or feeling feverish
  • cough
  • shortness of breath or difficulty breathing at rest or when active
  • sore throat
  • body pain or muscle pain/aches
  • fatigue
  • headache
  • chills
  • blocked nose/nasal congestion
  • runny nose
  • loss of taste or smell
  • nausea or vomiting
  • diarrhea
  • temperature ≥ 38°C (100.4°F)
  • Oxygen levels of ≥92% when resting (measured by study staff within 48 hours of participating in the study), unless participant is receiving long-term supplementary oxygen for an underlying lung condition.
  • Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.

You CAN'T join if...

  • History of or current hospitalization for COVID-19.
  • Current need for hospitalization or immediate medical attention.
  • Any use of the following medications up to 30 days before participating in the study:
  • Hydroxychloroquine (except for long-term autoimmune diseases)
  • Chloroquine and/or ivermectin (unless used for parasitic infection)
  • Remdesivir, systemic and inhaled steroids (unless used for long-term conditions)
  • HIV protease inhibitors (unless used long-term for HIV infection)
  • Receipt of plasma from a person who recovered from COVID-19 any time before participating in the study.
  • Receipt of a SARS-CoV-2 vaccine any time before participating in the study.
  • Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases).
  • Receipt of systemic steroids (e.g. prednisone, dexamethasone) or inhaled steroids up to 30 days before participating in the study, unless this is a stable dose for a long-term condition.
  • Known allergy/sensitivity or hypersensitivity to study drug or placebo.
  • Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Locations

  • University of California Irvine (Site 1083), 843 Health Sciences Road accepting new patients
    Orange California 92868 United States
  • St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd. accepting new patients
    Fullerton California 92835-3820 United States
  • Atella Clinical Research (Site 1111), 5451 La Palma Avenue accepting new patients
    La Palma California 90623 United States
Contact us about this trial