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Outpatients With COVID-19 Research Study Participants
UT Health
Houston, TX
job expired on 1/1/2021
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.
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