Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2022-04-29
2023-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Subsequent cohorts will receive AT-752/placebo either twice a day (BID) or TID
Study Groups
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AT-752 750-mg TID for 5 days
Tablet; 750-mg, Three (3) times a day for 5-days
AT-752
AT-752 for 5 days
Placebo
Placebo for 5 days
AT-752 Dose A for 5 days
Tablet; Dose A, for 5-days
AT-752
AT-752 for 5 days
Placebo
Placebo for 5 days
AT-752 Dose B for 5 days
Tablet; Dose B, for 5-days
AT-752
AT-752 for 5 days
Placebo
Placebo for 5 days
Interventions
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AT-752
AT-752 for 5 days
Placebo
Placebo for 5 days
Eligibility Criteria
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Inclusion Criteria
* Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours
* Live/work in or recent travel to dengue endemic area
* Positive test confirming Dengue (DENV) on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay
* Negative rapid diagnostic test result for Coronavirus (SARS-CoV-2) and Influenza A and B
Exclusion Criteria
* Has previously received any investigational or approved vaccine for dengue
* Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection (from medical history)
* Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite (for long-acting antivirals)
* Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders
* Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease
* Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids (inhaled or topical corticosteroids are allowed) or any current disease or condition
* Evidence of severe dengue disease
* Confirmed or suspected Coronavirus (SARS-CoV-2) infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening
* Other clinically significant medical conditions or laboratory abnormalities, as described in the protocol.
18 Years
55 Years
ALL
No
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Belo Horizonte, , Brazil
Atea Study Site
Campo Grande, , Brazil
Atea Study Site
Cuiabá, , Brazil
Atea Study Site
Manaus, , Brazil
Atea Study Site
Natal, , Brazil
Atea Study Site
Porto Velho, , Brazil
Atea Study Site
Recife, , Brazil
Atea Study Site
Ribeirão Preto, , Brazil
Atea Study Site
Rio de Janeiro, , Brazil
Atea Study Site
São José do Rio Preto, , Brazil
Atea Study Site
São Paulo, , Brazil
Atea Study Site
Aguazul, , Colombia
Atea Study Site
Antioquia, , Colombia
Atea Study Site
Cali, , Colombia
Atea Study Site
Girardot, , Colombia
Atea Study Site
Yopal, , Colombia
Atea Study Site
Machala, , Ecuador
Atea Study Site
Guwahati, , India
Atea Study Site
Kanpur, , India
Atea Study Site
Lucknow, , India
Atea Study Site
Sūrat, , India
Atea Study Site
Kuala Terengganu, , Malaysia
Atea Study Site
Perai, , Malaysia
Atea Study Site
Ica, , Peru
Atea Study Site
Iquitos, , Peru
Atea Study Site
Iloilo City, , Philippines
Atea Study Site
Las Piñas, , Philippines
Atea Study Site
Quezon City, , Philippines
Atea Study Site
Kaohsiung City, , Taiwan
Atea Study Site
Bangkok, , Thailand
Atea Study Site
Khon Kaen, , Thailand
Atea Study Site
Hanoi, , Vietnam
Countries
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Provided Documents
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Document Type: Study Protocol: Original Protocol
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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AT-02A-002
Identifier Type: -
Identifier Source: org_study_id
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