Outpatients With COVID-19 Research Study Participants
Company: UT Health
Location: Houston , TX
Category: Clinical Research Studies, General
Job Type: Full Time
Posted: 10/7/2020

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

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.



Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No


Inclusion Criteria

  • 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 thr   oat
    • body pain or m   uscle pain/aches
    • fatigue   
    • headache   
    • chills   
    • blocked nose   /nasal congestion
    • runny nose   
    • loss of taste or sm   ell
    • nausea or vomiting   
    • diarrhea   
    • temperature ≥ 3   8°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.


Exclusion Criteria

  • 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.

Houston, TX
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