Drug Treatment Study for Outpatients With COVID-19

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Official Study Title: Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID or ACTIV-2)

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 and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks. Study visits may be required after week 24 depending on the study agent.

What does the study involve?

People participating in ACTIV-2 will have frequent study visits at a research clinic or their home. In both Phase 2 and Phase 3, participants will be seen at the start of the study, then one month, three months, and six months later.  diary.

Who can participate?

  • Adults 18 years and older

Participants must have/be

  • Signed an informed consent.
  • Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen collected ≤240 hours (10 days) prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory
  • Positive test for COVID-19 up to 7 days before participation in study.
  • Able to begin study treatment no later than 8 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:
    • 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 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°)
    • Oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
    • 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.

Where is it taking place?

See the ACTIV-2.org for a list of locations or visit clinicaltrials.gov search query NCT04518410.

Steps to participate

Visit ACTIV-2.org and or call the call center at 877-345-8813. The call center representative ask will ask a few questions and connect volunteers with the appropriate clinical research site.

Visit ClinicalTrials.gov for details.

Contact Information

Website: www.activ-2.org 

Call Center phone number: 877-345-8813

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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